Adverse drug reactions symptoms and conditions

After you read a representative sampling of this website's testimonials, you certainly ask yourself inter alia: Can this be true? Did thousands of people inject an antibiotic from the fluoroquinolone family, which crippled them for longer or for shorter? Most of us, I suspect, never really get beyond the initial litmus test: Did this medicine poison me or save me? (The answer depends, of course, upon the age, gender, medical condition, and most importantly, the DNA make-up of the individual patient. For hundreds of thousands of patients this antibiotic is a boon. For thousands of other misfortunes this antibiotic is a disaster.) But there is another important question here.

Who gains from self-revelation? To be sure individual sufferers gain certain emotional catharsis from posting their adverse drug reactions (ADRs) to levaquin. E-postings are one-way anonymous tracks that form ruts on a well-traveled trail of tears. Unless these postings are hoaxes written by mischievious gnomes, then they consitute prima facie evidence for a causal link between levaquin injection and sundry crippling ADRs.

Curiously, this e-forum cannot be used as a tool for organizing thousands of potential litigants who might coalesce under a class action lawsuit. Yes, we can analyze each other's anonymous revelations to see if they muster our respective sense of the "ring-of-truth" re: levaquin toxicity, and we may contact each other one-on-one, but no-one can harness this intoxicating communication's technology to reach simultaneously all respondents en masse as a bloc.

So, who wins? The emotionally unburdened e-poster who learns belatedly that s/he is not alone and that prescription medicine likely caused more pain than the underlying malady for which s/he is being treated? Or big pharma that continues to manufacture and market a medication that poses downside risk to many consumers who unwittingly incur more damage than therapeutic value?

Indeed, who wins in a forum where consumers anonymously reveal their symptoms and unconfirmed suspicions? The answer is big pharma wins. Pharmaceutical companies data-mine our postings to estimate the frequency and bredth of ADRs about which consumers complain. House statisticians estimate the ratio of active complainants : silent complainants, i.e., the ratio of complaints who show up on this website to the far heftier percentage of complainants who never post on this website because either they are technology-challenged or they are incurious. House actuarians proceed to estimate how much operating profits their employers must set aside to cover losses in out-of-court settlements or in awards made to plaintiffs in class action lawsuits.

I think this is how the game is played in a behavioral sink where billions are made in a deregulated marketplace that allows predators and prey to interact anonymously. Sorry to be such a downer, but I fathom only the desperate plight of tens of thousands of levaquin consumers for whom no monetary award ever will compensate them adequately for their suffering, and the hundreds of millions of dollars at stake in court awards if consumers ever brought to bear their aggregate numbers and draw a bead on their big pharma tormenters.

I think it a true horror and shame that pharmaceutical companies have not devised a test which determines in advance which patient safely may consume levaquin and which patient's DNA places him or her at risk. I suspect the genome technology is available, but would dig too deeply into big pharm's bottom line. The economics of "parachutes-for-everyone" is infeasible. We are all guinea pigs in a B-grade movie featuring Russian roulette, billion-dollar pay-offs, and an FDA that pretends not to know.

I started singulair a week ago in order to treat my allergies and mild asma. At first, I did not realize that I had headaches and head pressure due to its adverse reactions. On Friday night after my dinner I got very bad vertigo, and I did not take singulair for a day. Believe it or not my vertigo and headache went away. Tonight, I tried it again, and my ear and head pain came back.
I am calling my doctor tomorrow and stopping it right away.
Thank you all sharing your experiences.
V.

Has anyone been in contact with any doctors, hospitals, or researchers who are willing to recognize that Singulair targets a receptor CysLT1, with known genetic variations? As you know, I have been posting that I know of researchers who are doing work about how the genetic variations can determine the efficacy of Singulair. If genetic variations cause differences in efficacy, then, of course, these variations can also cause unpleasant to very serious side effects. These seems to be some kind of disconnect. How can the genetic component be recognized in the area of efficacy and ignored in the area of adverse drug reactions?

The United Kingdom's Medicines and Healthcare Products Regulatory Agency posts medication adverse event reports on their website.

safety information, reporting safety problems, medicines, reporting suspected adverse drug reactions, drug analysis prints (DAPs), search for "montelukast"

This is my third posting. At this URL thousands of people have recounted how they were were poisoned by medicine that was supposed to make them well. Reading these accounts is like watching a science fiction horror film. One after another over the course of five years since medicines.com began posting their respective experiences, another hapless victim falls headlong into the levaquin trap. It's like watching cars crash on a fog-filled highway. Suggestible doctors rely upon marketing representations by pharmaceutical reps. Doe-eyed patients fill with confidence their doctors' prescriptions. A small percentage of these presciptees --- what % we likely will never know --- suffers severe adverse reactions that change their lives forever. There are several thousand accounts of adverse drug reactions (ADRs) re: levaquin on this website alone. There must be ten times that number of computer illiterates or incurious who experienced ADRs but who never posted their stories on medicines.com. Insofar as Levequin poisoning can appear many months after the prescription-taker discontinued taking his/her prescription, one wonders separately how many people became blind-sided by symptoms which the ADR sufferer never remotely traced back to quinolones. Suddenly out-of-the-blue a hapless victim is felled by symptoms that require exhaustive medical testing. No-one intended this DNA-changing drug to create full employment for medical personnel. Ironically Levaquin poisoning has created a pharmaceutical aftermarket for medical professionals who occupy a no-lose proposition: Either Levaquin will cure what ails you now, or consequent Levaquin poisoning will put you at the head of the line for additional testing. The right hand unwittingly prescribes a poison while the left hand tests you and treats you for a possible antidote! It's really a half-wit's delight with possibly deadly consequences. The FDA bows to the invisible hand of deregulation and social Darwinism: What doesn't kill you makes you better. If enough people complain about their ADRs, the FDA might or might not post a black box warning about the prescription drug's adverse effect. But unaddressed is the crucial link between commission-incented pharmaceutical marketing reps and their prey ---- harried doctors who are too busy to read the contraindications' fine print. Big pharmacy knows well the drill, and has earmarked a percentage of company profits and set them aside to cover the inevitable lawsuits from crippled Levqauin consumers and/or their heirs. Big pharma's profits exceed big pharma's court-mandated awards. The hubaballo dies-down about the time the FDA has weighed-in with warnings and after big pharma has retired its belatedly discredited antibiotic in favor of marketing a **miracle** new generation replacement. It's Sisyphus (look it up) all over! It's hard not to be cynical and bitter. This is the equivalent of taking incoming "friendly fire" in the medical profession. With ADRs like these who needs illness? Just take the medicine and proceed right to sick.

Comment: What is behind the ignorance and denial found within the medical community regarding the true safety profile of the fluoroquinolones?

An editorial in response to the FDA's recent addition of "Black Box Warnings" to the fluoroquinolone class.

Written by the Director of the Fluoroquinolone Toxicity Research Foundation, Mr. David T. Fuller.

The Fluoroquinolone Toxicity Research Foundation continues to collect post-marketing reports regarding the non-abating nature of the severe and crippling adverse drug reactions associated with fluoroquinolone therapy via the Internet. Ever since the research forum went on line, the Fluoroquinolone Toxicity Research Forum hosted by Yahoo has received thousands of reports, including numerous associated fatalities. The homepage for the Fluoroquinolone Toxicity Research Foundation, www.fqresearch.org has accumulated over 4000 medical journal entries, newspaper articles, post marketing reports, lawsuits and other such supporting data the clearly shows the rampant ignorance and denial within the medical community regarding the non-abating nature of such events.

For more than forty years, since the introduction of Nalidixic Acid in 1962, the victims of fluoroquinolone toxicity have been denied the medical care they so desperately need as their physicians have routinely failed to recognize, treat and report such events. Peripheral Neuropathy, spontaneous tendon rupture, severe and non abating joint and tendon damage, resulting from such toxicity, are all known, listed and published adverse drug reactions to these chemotherapeutic agents, commonly referred to as fluoroquinolones or quinolones. Yet the victims continue to be told by their physicians "it cannot be the drug".

Numerous news stories since the anthrax scare back in 2001 have documented such injuries, with the most recent being the death of the daughter of one member of the research forum, whose death was the direct result of such careless scripting of these toxic and dangerous drugs. Another forum, the quinolone adverse drug reaction forum, hosted by Yahoo since February 14, 1999, has accumulated over 57,000 such post regarding the damage this class of chemotherapeutic agents can and will do. The law firm of Sheller, Ludwig and Badey, one of the largest class action and medical malpractice firm in the Northeast, had filed a class action lawsuit against Bayer AG, the manufacturer of Cipro. This suit was filed on behalf of all those who have suffered such damage including the Capitol Hill Staff, the Washington Postal Workers, and the employees of the American Media who were exposed to Ciprofloxacin as a result of the Anthrax Scare. This suit was later withdrawn alleged to be the result of the astronomical cost of such litigation.

In spite of the overwhelming evidence of the non-abating nature of such injuries, the FDA continues to approve new drugs within this class together with new indications for those already on the market. Ignoring the 9,711 reports that include 806 associated deaths and 39,128 total reactions found within the AERS reports for Levofloxacin. (Levaquin Nov. 1997 - May 30, 2007) In 2004 these numbers were 5,276 reports, 473 associated deaths and 19,792 total reactions respectively. Together with the 8,766 reports which include 837 associated deaths and 40,395 total reactions for Ciprofloxacin found within the AERS reports as well. (Nov. 1, 1997 - June 5, 2007) Where as these numbers were 4,995 reports, 480 associated deaths and 20,890 total reactions in 2004. As well as the following:

Floxin: Nov. 1997 - May 30, 2007

Total reactions: 13,495

Total death outcomes by case: 311

Total individual safety reports: 2,962

Proquin (ciprofloxacin) Nov. 1, 1997 - June 5, 2007

Total reactions: 40,151

Total death outcomes by case: 831

Total individual safety reports: 8,688

Tequin: Nov. 1997 - June 5, 2007

Total reactions: 15,494

Total death outcomes by case: 196

Total individual safety reports: 5,307

Factive: Nov. 1997 - June 5, 2007

Total reactions: 1,979

Total death outcomes by case: 7

Total individual safety reports: 1,108

Avelox: Nov. 1997 - June 5, 2007

Total reactions: 30,160

Total death outcomes by case: 337

Total individual safety reports: 7,391

Almost fifty percent of such chemotherapeutic agents have been removed from clinical practice or their use severely curtailed, due to toxicity issues. Yet, Mr. MacCarthy, the 2001 Vice President of U.S. Medical Science at Bayer's West Haven facility stated in 2001"If you are telling me that someone had these effects and they were persisting, long term, months to years after treatment I would be surprised."

The members of the Fluoroquinolone Toxicity Research Foundation had been telling Mr. MacCarthy's employer exactly that for years prior to him making such a statement to the press. Those within the media who have an interest in interviewing those who "had these effects and they were persisting, long term, months to years after treatment" are welcomed to visit our website and forum. For we state unequivocally that Mr. MacCarthy was being less than forthright in the statements he had made back in 2001. Such documentation has been made available to the firm he works for year after year. The adverse reactions experienced by the members have shown to be both persistent and non-abating, "year after year", contrary to what Mr. MacCarthy had stated publicly. As one member of the forum so eloquently stated, "Mr. MacCarthy is mistakened"(sic) as we have the documentation as well as hundreds of such victims to prove all that we state here which is available for public scrutiny.”

Those within the media who have an interest in interviewing those who “had these effects and they were persisting, long term, months to years after treatment” are welcomed to visit this any one of the thousands of such websites found on the Internet as well. Mr. MacCarthy apparently could not be bothered to take the time to do so prior to making the comments that he had in 2001, in my humble opinion.

Here we are SEVEN years later, and we still continue to hear such denials from the manufacturers and the medical community even though these numbers have increased dramatically. Levaquin has been reported as having the most numerous, non-abating and severe adverse drug reactions associated with its use on Mediciations.com

A review of the online adverse drug reaction reporting forum: www.Medications.com (October 2002 – February 2004) revealed that Levaquin was associated with approximately 17% of ALL adverse drug reactions being reported to this site, irregardless of the drug being reported upon. Medications.com started receiving such reports as of October of 2002. Medications.com is an Internet community that allows people interested in commonly prescribed drugs to interact so that they can discuss the implications -- both positive and negative of using these important tools in modern medicine. Medications.com list over 4,500 drugs in common use to date, users have posted thousands of side effects and messages about many of these drugs.

The total number of adverse reactions, regardless of the drug mentioned, as of 2-11-2004, totals approximately 4,469. Levaquin, by far, received more such post than ANY other fluoroquinolone drug listed on this site. Of the 774 adverse reactions reported for all of the fluoroquinolones listed, 752 were for Levaquin. The only fatality listed for a fluoroquinolone was for Levaquin. 97.5% of all adverse reactions to the fluoroquinolones were reported for Levaquin. As such reports are received anonymously the verification of such reports was not feasible nor did we attempt this. But one can assume that receiving this many reports over a sixteen-month period that the majority of such reports are indeed valid. This study also lacks the necessary controls required to present the above as fact and as such should be viewed for debating purposes only.

A review of the side effects posted on Medications.com (October 2002 – February 2004) for the fluoroquinolones used in clinical practice in the United States revealed the following:

Avelox 8 post

Ciprofloxacin 7 post

Floxin 5 post

Levaquin 752 post w/(1) fatality

Tequin 2 post

The predominate adverse reactions reported for Levaquin are as follows:

Nuerotoxicity

Tendon Damage and or rupture

Insomnia

Non abating injury (multiskeletical)

Peripheral Neuropathy

Gastrointestinal

Anxiety and Panic attacks

Vision Problems

Rash, sweats, taste perversions, hearing loss

ALL of which those who suffer such reactions are being told by the treating physician to have no association with fluoroquinolone therapy. This trend is repeated on a number of adverse drug reaction forums dealing with the adverse drug reactions as they relate to the Fluoroquinolones. As the above data has not been verified other than visiting this site and doing a physical count the absolute accuracy has not been determined.

Since the time that this analysis was performed the numbers have increased so dramatically to the point that it is no longer feasible to even attempt such a comparison today. And yet the NUMBER ONE drug with the most adverse reactions, as well as the most severe adverse reactions, continues to be levaquin on that site.

In spite of the overwhelming evidence presented at that 62 Meeting of the Anti-Infective Drugs Advisory Committee that the fluoroquinolones cause irreversible joint damage in the pediatric population the FDA has recently added the use of Ciprofloxacin in the pediatric population, Treating children as young as one years of age. We are currently faced with a clear and present danger regarding these drugs as the FDA, ignoring the tragic results of such careless scripting, has now authorized this use knowing full well that the physician will continue to abuse their discretion.

I challenge the FDA to explain to me how they expect a child who cannot even walk or talk yet to register a complaint of joint and tendon pain. Numerous studies have indicated that such use in a pediatric patient runs the risk of crippling the child for life. One such patient has undergone numerous surgeries to repair this damage and remains crippled to this day. Yet additional clinical trials continue aided and abetted by the FDA, for other drugs in this class other than Ciprofloxacin. A disaster that is detailed within the 62nd meeting of the Anti-Infective Drugs Advisory Committee where it was so eloquently stated:

“…when we talk about the issue of arthropathy that potentially includes a number of things, ranging from simple effusion, for instance, of a knee joint, which might rapidly resolve after the conclusion of therapy, to a more permanent disability. ..” (sic)

“…in September of 1997 there is now a ciprofloxacin suspension which is available, and although it continues to have the same warning statements about arthropathy in juvenile animals and the potential concern in pediatric populations, obviously, the issue of off label use will extend over to pediatric populations in this formulation….”(sic)

“…An important safety question is, what adverse events should be monitored, and Doctor Goldberger alluded to this earlier. This is some of the examples I present. One is permanent lameness, reversible lameness, joint effusion, joint pain, and even latent articular disease or damage that may occur months or years following drug exposure, and there may be others….”(sic)

“…And, data submitted to the Agency, as well as data from the scientific literature, indicate that these lesions don't appear to be reversible…”(sic)

“…Doctor Stahlmann in Berlin is working on an idea that it may be an effect between the endocrines, the magnesium and the matrix and the quinolone. And that data is just coming out now. But as to the exact mechanism, I think you're right. I don't think we have a handle, as far as I know, on the exact mechanism. If there's anybody else that does, I'd sure like to hear it…”(sic)

“… Relating your personal experience, I was wondering about the potential for a delayed effect that in fact one might have a patient who had some histologic changes that would not be manifest clinically for many years. Is that a potential?” (sic)

“… I think it is a potential…”(sic)

“… In trying to assess toxicity with a very sensitive assay, obviously you've got tissue that you can look at in your animal models. There is some human data that were collected by Doctor Urs Schaad using MRI scanning in children and I'm wondering if you can correlate some of your histopathologic findings with MR in the animal model to give us an idea of how sensitive it would be sort of as a follow-up to Doctor Klein's question is the MR something that will be able to predict long-term outcomes, even if there are no clinical symptoms during therapy….”(sic)

“… That I don't know. I'll just be perfectly frank. I don't know. But on the slides I've seen from the animals from the chronic study, the repaired articular cartilage that is there is principally fibrocartilage yet it will provide the same joint margin and it has a calcified base and when we stain it with safrain O screen there's no proteoglycans there so it's going to make it an extremely chondromalaistic area and beyond the one year I can't tell you what the results will be…”(sic)

“…Anyway, it was by a group in Vienna where they looked at the articular cartilage of postmortem specimens of articular cartilage from kids with cystic fibrosis that had been on quinolones for a period of time and they found that there was damage in the chondrocytes….”(sic)

“…There were no deaths reported in U.S. pediatric zero to 18 year old cases where a flouroquinolone was reported as the suspect drug. However, there are eight deaths in the whole cohort of suspect and concomitant flouroquinolone drug reports in the system. Five of these deaths reported ciprofloxacin as a concomitant drug and not the suspect drug. These five were U.S. cases with ages ranging from seven months to six years. The remaining three deaths were all foreign, all 18 year old patients with either ofloxacin or norfloxacin reported as the suspect drug….”(sic)

“…There are 14 reports of arthropathy or arthralgia in the pediatric zero to 18 year old flouroquinolone reports. One report of a 14 year old girl had both ofloxacin and lomefloxacin as the suspect drug so there is an extra count because of the two flouroquinolones on this one report. This particular report indicates that a pediatric orthopedic surgeon diagnosed femoral anteversion as the cause for the girl's arthralgia, therefore you see it listed twice, and not the flouroquinolones. Most of the reports indicated that either an involved knee or elbow with or without other joints was involved….”(sic)

“…One interesting case which is not included on this slide for arthralgias was a 15 year old boy who received ofloxacin IV for an emergency appendectomy and had not grown more than his 70 inches in height over the last year. The 15th percentile for height for a 15 year old boy however is 66.5 inches and the expected growth rate is about two inches per year…”(sic)

“…Three patients had their seizure after the first dose of flouroquinolone, one on ciprofloxacin and the other two on ofloxacin, one of which had received ofloxacin several months earlier…”(sic)

“…The 15 psychiatric reports are a loose grouping of reports which include events ranging from euphoria to psychosis. The ages range from five to 18 years with the median at 15 years. There were two suicide attempts, one on ofloxacin and the other on norfloxacin, three reports of hallucination, one each on ciprofloxacin, ofloxacin and norfloxacin, and one report of aggressive behavior with confusion in a patient who had a psychiatric history and was on norfloxacin. The seven cases of photosensitivity were reported with lomefloxacin with one case on ciprofloxacin and two cases on ofloxacin. …”(sic)

“…I will mention that there were 152 U.S. cases aged zero to 18 years in the U.S. AERS system suspect flouroquinolones in the WHO line listing. The country with the most pediatric reports in the WHO foreign reports is the United Kingdom with 177 reports followed by Germany with 72 and France with 71. The rest of the countries had 20 or fewer reports….”(sic)

“…And with regards to muscular-skeletal events, 21 percent of the patients had an event in ciprofloxacin…”(sic)

“…We have focused our analysis on joint disorders and pefloxacin. 79 cases were reported and consist mainly of arthralgia. I don't know the pronunciation of hydrarthrosis -- 49 persons. It involved the knee in 52 cases, the wrist in 20 cases, the elbow in 20 cases, the shoulder in 6 cases, the ankle in 5 cases, and the hip once. It is associated with a functional discomfort in all cases, and when the duration of this discomfort is known, it can persist more than one month in 61 percent of these cases. But the outcome was favorable in 58 cases without discontinuation in two cases. …”(sic)

“…There have been sequelae in three cases with knee effusions persisting one year later in one case with discomfort following 8 months later in the second case. The third case is articular. It is a 17-year-old patient who experienced arthropathy and the drug was not suspected and the treatment was continued two following months. It leads to destructive arthropathy of the knees and the hip and prothesis was performed three years later. He was treated for a cerebral abscess. The outcome was unknown in 18 cases. In 9 cases, there was no follow-up. In the 9 last cases, we had a follow-up three months later and patients were not -- were still with disabilities and after we have no evolution….” (sic)

“… It is my understanding that one of the children had a joint replacement, is that correct?”

“ Pardon me?”

“ One of the children with the complications had an artificial joint replacement?”

“Yes.”

“…If an irreversible cartilaginous lesion can occur, it is very likely that is going to cause problems down the line and we can't even anticipate what they are like…” (sic)

In spite of the following proven horrendous side effects:

Permanent disability

Permanent lameness

Joint effusion

Joint pain

Latent articular disease or damage that may occur months or years following drug exposure

Lesions that don't appear to be reversible

Potential for a delayed effect that would not be manifest clinically for many years

Damage in the chondrocytes

Eight deaths (five of which involved Ciprofloxacin)

14 reports of arthropathy

Seizures

Stunted growth

Suicide attempts

Hallucinations

Photosensitivity

Knee effusions persisting one year later with destructive arthropathy of the knees and the hip

(And with regards to muscular-skeletal events, 21 percent of the patients had an event in

Ciprofloxacin)

As one member of this advisory committee stated “…If an irreversible cartilaginous lesion can occur, it is very likely that is going to cause problems down the line and we can't even anticipate what they are like…”

As such the FDA has no idea what risk these children face nor how to treat such events once they occur.

Yet in conclusion this committee stated “…We clearly want to encourage development of these drug for use in pediatrics…”.

Within the newest package insert for Ciprofloxacin we find peripheral neuropathy being added as a severe, non-abating adverse drug reaction. A disease state in which the peripheral nerves are so badly damaged the patient will spend the rest of their natural life in severe, non-abating pain for there is no treatment protocol available for such a disease state that offers any relief. But we see no “Black Box Warning” concerning this. Of additional concern is the fact that there are also ongoing clinical trials regarding the use of other chemotherapeutic agents within this class involving pediatric patients as young as six months of age.

For more than forty years since the introduction of Nalidixic Acid in 1962, severe and permanent injury to the patient has been documented. Not one year in the past twenty six has gone by without additional articles being published in the leading medical journals documenting the horrendous damage these drugs can and will do since the introduction of Nalidixic Acic. Now the FDA has given their blessing on the use of chemotherapeutic agents within the pediatric population.

The use of these drugs will NOT be restricted to the approved indications either. The FDA has stated “…obviously, the issue of off label use will extend over to pediatric populations …” So now a child with a minor ear ache or sore throat will risk being crippled for the rest of their lives and the FDA will continue to turn a blind eye to such abuse for it is NOT within the legal rights of the FDA to control how such drugs are used once they have been approved. The FDA has no say in the manner in which a physician chooses to utilized a drug once it has been approved.

As such we now look forward to a whole generation of pediatric patients being destroyed by the careless manner in which such drugs are utilized and the treating physician will continue to fail to recognize, treat and report such events. Just as they have been doing for the past forty six years. Numerous forums now exist on the Internet in which the adult patients have been reporting such severe reactions since 1999. We can all now look forward to the distraught parents of these children joining such forums as a direct result of this total and complete failure of the FDA to protect the health and welfare of the pediatric population. Ignoring their own research and the findings of their advisory committee, they have approved a proven dangerous and toxic drug for the use in children.

The Fluoroquinolone Toxicity Research Foundation continues to collect post-marketing reports regarding the non-abating nature of the severe and crippling (and at times fatal) adverse drug reactions associated with fluoroquinolone therapy via the Internet. Since one of the first such forums went on line back in 1999, over nine years worth of horror stories regarding the damage these drugs can and will do have been forwarded to the FDA. In spite of the overwhelming evidence of such severe and at times fatal adverse reactions, the FDA continues to refuse to take action. In a letter we received from the FDA, (circa 2004) Frances T. Gipson, FACHE Office of Executive Programs Center for Drug Evaluation and Research, stated that “…we will weigh all risks and benefits associated with Fluoroquinolone Class Drugs prior to taking any additional action…We will continue to monitor future adverse events reported to us.” To add insult to injury regarding such inaction by the FDA, Gipson also states “…It was also noted that the majority of those adverse events reported are well-known side effects of the Fluoroquinolone class of drugs…” Three years later (circa 2007) Public Citizen received a reply from the FDA to their petition seeking Black Box Warnings stating the very same thing almost word for word. So did the Attorney General of the State of Illinois in response to their petition filed a year earlier.

For more than forty six years, since the introduction of Nalidixic Acid in 1962, the victims of fluoroquinolone toxicity have been reporting such “well-known side effects”, only to be denied the medical care they so desperately need as their physicians have routinely failed to recognize, treat and report such events. Peripheral Neuropathy, spontaneous tendon rupture, severe and non abating joint and tendon damage, as well as fatalities resulting from such toxicity, are all known, listed and published adverse drug reactions to these chemotherapeutic agents, commonly referred to as fluoroquinolones or quinolones. Yet the victims continue to be told by their physicians “it cannot be the drug” and the FDA continues to “monitor future adverse events.” It surely does not get any sicker than this.

Numerous sites continue to be added to the Internet dealing with these reactions in an effort to draw media attention to those of us who are left outside the city gates, like lepers to be pitied and ignored. On any one of these sites you will find tens of thousands of case histories, posted in the very words of the victims themselves, which describe the horrific suffering they or their loved ones have endured as a direct result of the FDA’s failure to prevent such carnage. You will also find postings regarding those who have forfeited their lives due to the rampant ignorance regarding the adverse reactions associated with these chemotherapeutic agents.

The recent addition of this frivolous “Black Box Warning” only emphasizes the fact that such adverse reactions experienced by such victims have shown to be both persistent and non-abating, “year after year”, contrary to what Mr. MacCarthy had stated publicly seven years ago. The comments made within the video presented by the good doctor from John Hopkins emphasizes the fact that NOTHING has changed since then either when it comes to the rampant ignorance found within the medical community.

Since 1999, over nine years ago, we now have added over fifteen different sites to the Internet that deals with these issues. All dealing with what Mr. MacCarthy claimed to have no knowledge of. Perhaps he may wish to read the postings under “In Fond Memory Of” on the fqvictims site. It has been stated that “dead men tell no tales” but thanks to the efforts of those involved with bringing this new site on line; they have been given a chance to do exactly that. For you will find post after post detailing the horrendous manner in which such fatalities related to the careless and thoughtless use of these dangerous drugs, have occurred. No doubt Mr. MacCarthy has no knowledge of the permanent nature of such reactions either. Over a thousand documented fatalities, forty thousand severe adverse reactions, four thousand medical journal entries, fifteen new adverse reaction websites, nine years worth of post marketing reports, and the FDA continues to state that they intend to “continue to monitor future adverse events reported to us”. The victims continue to report the carnage, yet no one is listening. Perhaps with this “new” warning, somebody, somewhere, will. But somehow I rather doubt that we will find that they work at the FDA.

You would also note that Internet sites that published this new warning and allowed people to post a comment have been overwhelmed with patient’s complaints. I rather doubt that this would be taking place unless the drug in question is truly defective. People have far better things to do with their time I would imagine.

Mr. David T. Fuller

Director

Fluoroquinolone Toxicity Research Foundation

www.fqreseach.org

fqresearch@aol.com

davidtfull@aol.com

About the Fluoroquinolone Toxicity Research Foundation

The foundation is a non profit organization consisting of those who have suffered irreversible and non-abating injury as a direct result of fluoroquinolone therapy. The foundation is dedicated to presenting the research regarding these issues in the hope of preventing such injury to others and to make such research readily available to those who have shown a prior interest. We strive to present accurate and up to date information to the victims of such scripting abuse so that they may be in a position to receive the medical care such rampant ignorance has denied them. Such documentation is readily available via the forum or the homepage www.fqresearch.org

The author of this Editorial has NO financial ties whatsoever with anyone found within the legal or medical field. There are no known conflicts of interest to disclose, and the Foundation has never accepted any donations, of any kind, from any person, corporation, or special interest group since it's inception.

Levaquin is a wonderful drug and one of a very few that help men with prostatitis. If you have ever suffered with a prostatitis infection you know what i mean. No problems here with Leviquin.

I took Levaquin for a kidney infection 500 mg. I was inchy all over. stomach pain. sever neck pain, and pain all over I feel like I was hit by a truck. no energy. my eyes get all heavy like I haven't slept in weeks. Alls I do is sleep and when I do I wake up very confused. I've been taking naps in the day time which I've never been able to do even if I was sick. I don't feel normal like I'm drunk and I don't even drink my sister says I even sound drunk. I get headaches. I have bruises all over in the places that I had itched. I still have kidney pain it feels like it's flopping around in there. Sweat a lot at night time. My heart sometimes beats really fast then thunks hard and then slows down. anxiety attacks. I cry for no reason. I called my doctor and he said he don't think it's from the levaquin that people only get a couple side effects not this many and put me back on antibiotics.

I have been taking Levaquin for sinus infection after Augmentin didn't keep it from coming back. All I can say is that I am completely exhausted. I wonder if it is the drug or something else. No muscle pain. I don't know if I should stop taking it or continue. Tonight I was walking for exercise and couldn't finish because I thought I might faint. My heart was beating and I was shaking. Do you think it is the drug? HELP!

I started taking Singulair and the first two days I felt better, but by the 3rd day I started feeling like I was trying to get sick. By day 8 I was in the Emergency Room with a very rapid heartbeat (166 beats per minute), and a severe Upper Respiratory Infection. They did blood and urine work, chest x-rays, CAT Scan, etc. and found nothing wrong with me. I kept telling them that I was having a reaction to the Singulair, and even though they never actually admitted it, they did say it was possible. I KNOW it was Singulair. I will NEVER take it again. They need to take it off the market. I was in the hospital for 3 days because of this dangerous drug!

I would like to urge everyone to report adverse drug reactions to the FDA. Without a supporting data base, things move way too slowly and other people get hurt. I was doing some further work on quinolines/quinolones and ran across a medical researcher who starting writing about quinolones in 2001. The warnings that finally appeared on the quinolone drugs were placed in 2005. Let's do everything to keeping that from happening to parents.

Here is the researcher who wrote about quinolones so that you will have the reference.

******

I've noticed that NBC and The Weather Channel appear to be two of the biggest advertisers of Singulair. NBC can always be sure to have one on during the evening news, at least here where we live, on our local NBC channel. There for awhile, I was logging what time, and what channel I saw the ad. The ad only lists the basic side effects that aren't even dangerous. Merck must be paying NBC the big bucks because they still haven't dropped it. I don't know, should we bombard NBC with letters of negativity or boycott or something to get their attention on this murderous drug?

I don't think that anyone can predict a time frame for getting over an adverse drug reaction. Below is my opinion but I see a lot of evidence that it is basically shared by other people maybe not exactly as I state it.

Adverse drug reactions deplete many essential nutrients from our systems. Inflammatory response is very stressful on the body. It is sometimes a very big effort to work on the diet to put back what has been taken away. It can take a long time.

Quinolines particularly deplete B-vitamins, folic acid (B-9), calcium/magnesium/zinc and omega-3 fatty acid. Sometimes the blood-lab work shows elevated homocysteine which proves that the body has suffered inflammation. Cardiologists now use homocysteine levels to show whether someone is at risk for heart disease due to inflammation. Deficiencies of B-6, B-9, and B-12 are known to cause elevated homocysteine.

Here is the pharmaceutical company ZINGER. Now companies such as Merck and Pfizer are going to offer niacin products to lower cholesterol. Well, yeh, duh !. All of these drug reactions are causing depleted B vitamins which elevate cholesterol. Then after they have tried to kill us by depleting our B - vitamins, they want to sell us another pill to give the B vitamins back to us. How many people out there are on some kind of a pill with side effects that cause inflammation? What a business? It is win, win, win.

Quinolinic acid and neurotoxicity:

Montelukast contains a quinoline radical. Quinolinic acid, a well known damaging neurotoxin that kills neurons, can be produced from a quinoline and hydrogen peroxide. The body produces hydrogen peroxide for a numbers of reasons. White blood cells produce hydrogen peroxide when activated by antigens such as bacteria, virus, fungus etc. It is also produced under conditions when the body is stressed. It is also produced in the gastrointestinal track.

If we knew how montelukast could break up to free the quinoline radical, then we might be able to define a number of different scenarios under which hydrogen peroxide could cause montelukast to generate the neurotoxin quinolinic acid.

If we could prove that montelukast is capable of produce quinolinic acid under unusual circumstances (doesn't happen to everybody), then we would have a very good explanation for all of the psychiatric adverse drug reactions that are mentioned here which include hallucinations, anxiety, depression, suicidal ideations, night mares, etc. etc.

Anyone looking for answers should try to pursue the possibility that quinolinic acid is causing bad side effects. I wish that I was much better at chemistry. I am stuck here at the moment. I keep hoping that somebody else with more expertise will come here to tell us how it happens.

Sorry, I can't just walk away.

When you find patents or patent applications for certain purposes, then you know that your ideas are well founded. There are several patents for using an anti-malaria drug for asthma. I would bet that somebody had that idea all the way back to the 1960's. So it is very possibly no coincidence at all that a chloroquinoline or other quinoline ring would be part of montelukast's chemical structure.

Here is one of the patents.

******

It is well known that quinoline rings can be toxic to some people even very rapidly. As in this very extreme example.
--------------------------------------------------------------------------

PEDIATRICS Vol. 27 No. 1 January 1961, pp. 95-102 This Article

FATAL ACUTE CHLOROQUINE POISONING IN CHILDREN
Howard M. Cann M.D.1 and Henry L. Verhulst M.S.1

1 National Clearinghouse for Poison Control Centers, Accident Prevention Program, Public Health Service, U. S. Department of Health, Education, and Welfare
Four cases of acute chloroquine poisoning in children are presented. In three instances death occurred within 2 hours of ingestion of larger than therapeutic amounts of the drug. The rapid occurrence of death in acute chloroquine poisoning is probably explained by complete and rapid absorption of the drug from the gastrointestinal tract resulting in high blood concentrations which depress vasomotor function and respiration. Cardiac arrest follows and may be caused by the direct myocardial action of chloroquine, to anoxia, or to both. The similarity of the manifestations of acute chloroquine poisoning and those of acute quinine and quinidine poisoning suggests that acute toxicity may be attributed to the quinoline ring portion of these drugs.

----------------------------------------------------------------------------------

I don't think that we are seeing extreme examples. But we may be seeing less extreme immediate reactions or reactions where the toxicity builds up over time.

Quinoline rings are know to cause neurotoxicity. There are theories about how that happens. One of the theories is about blocking connexins which are gap junction proteins in the brains.

I don't know how montelukast could be breaking up so that it causes toxicity. Or if the problem is the how rapidly the liver enzymes can metabolize it. But there is plenty, plenty, plenty of clinical evidence that there is a quinoline ring culprit somewhere in the picture. Or some by-product of that causing problems.

Somehow it was decided that montelukast did not have the safety issues that the other drugs in the same category have. See this.

"The starting point in the development of montelukast appears to be a quinoline-containing structure, likely identified as a weak random screening lead (Figure 3). The Merck group hypothesized that this molecule was mimicking the olefin backbone of cysLTs, and that the addition of mimics for the acid and peptide regions of LTD4, might improve its potency. As a first step, the dithioacetal linkage first seen in some SmithKline compounds was incorporated; this led to a compound with greatly increased in vitro potency but poor oral bioavailability. When one of the carboxylic acids was replaced by an amide, forming MK-571, the new antagonist had even greater potency and good efficacy following oral administration. The enantiomers were resolved to yield MK-679 (verlukast), a compound with better clinical effects than MK-571, but whose clinical development was stopped for safety reasons. Further structure-activity relationship studies led to the development of montelukast (16), an antagonist that appears free of the safety concerns plaguing earlier members of this series."

If we can find out why the earlier versions were not safe and how they thought fixed it, then maybe we can find out what is going on with the quinoline ring in some people.

I would be very surprised if the FDA will address our concerns. Why does it always seem like they wait for enough people to die like in Vioxx? Wasn't Vioxx responsible for thousands of deaths?

Hopefully this will prove to the doubters that there are genetic reasons for the variation of efficacy and adverse side effective when taking Montelukast.

I have several areas of concern (concerned citizen is concerned). One of the main areas is the reliability of Montelukast due to differences in genetics among populations. The cysLT1 (Singulair) receptor is a GENE. As I said before, it would be possible to predict those patients for which Montelukast would and would not be effective and those patients whose gene expression profile would cause them to have unwanted side effectives.

I have been looking for a way to give reasonable proof of that which could be used to convince your doctors that Montelukast is not for everybody. I happened to locate a researcher who had invented and patented methods for predicting drug sensitivity and efficacy in inflammatory disease. I have quoted below from his patent application. He intended to provide a method for determining efficacy and drug sensitivity for pharmaceuticals which include leukotriene antagonists - Montelukast.

Quoted from:

Methods for predicting drug sensitivity in patients afflicted with an inflammatory disease
US Patent Issued on December 12, 2006

Methods are disclosed for predicting the efficacy of a drug for treating an inflammatory disease in a human patient, including: obtaining a sample of cells from the patient; obtaining a gene expression profile of the sample in the absence and presence of in vitro modulation of the cells with specific cytokines and/or mediators; and comparing the gene expression profile of the sample with a reference gene expression profile, wherein similarities between the sample expression profile and the reference expression profile predicts the efficacy of the drug for treating the inflammatory disease in the patient.

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The field of pharmacogenomics measures differences in the effect of medications that are caused by genetic variations. Such differences are manifested by differences in the therapeutic effects or adverse events of drugs. For most drugs, the genetic variations that potentially characterize drug-responsive patients from non-responders remain unknown.
---------------------------------------------------------

In another embodiment, the invention is directed to a method for predicting the efficacy in a human asthma patient of leukotriene antagonists including, but not limited to, montelukast (a.k.a., SINGULAIR™; Merck, Whitehouse Station, N.J.), zafirlukast (a.k.a., ACCOLATE™, AstraZeneca, Wilmington, Del.), and zileuton (a.k.a., ZYFLO™; Abbott Laboratories, Chicago, Ill.), comprising: obtaining a sample of cells from the patient; obtaining a gene expression profile from the sample in the absence and presence of in vitro modulation of the cells with specific mediators; and comparing the gene expression profile of the sample with a reference gene expression profile, wherein similarity in expression profiles between the sample and reference profiles predicts the efficacy in the human asthmatic patient of leukotriene antagonists.

Many of the cells involved in causing airway inflammation are known to produce signaling molecules within the body called "leukotrienes." Leukotrienes are responsible for causing the contraction of the airway smooth muscle, increasing leakage of fluid from blood vessels in the lung, and further promoting inflammation by attracting other inflammatory cells into the airways. Oral anti-leukotriene medications have been introduced to fight the inflammatory response typical of allergic disease. These drugs are used in the treatment of chronic asthma. Recent data demonstrates that prescribed anti-leukotriene medications can be beneficial for many patients with asthma, however, a significant number of patients do not respond to anti-leukotriene drugs.

--------------------------------------------------

The genes selected are those that have been determined to be differentially expressed in either a disease, drug-responsiveness, or drug-sensitive cell relative to a normal cell and confer power to predict the response to the drug. By comparing tissue samples from patients with these reference expression profiles, the patient's susceptibility to a particular disease, drug-responsiveness, or drug-resistance can be determined.

http://www.patentstorm.us/patents/7148008-description.html

The inventor's website: Hakon Hakonarson M.D. The Children's Hospital of Philadelphia

http://stokes.chop.edu/research/profiles/?ID=251

Health insurance companies starting to use databases to identify possible adverse drug reactions problems.

Data Mining Prescribed To Ensure Drug Safety

WellPoint's "Safety Sentinel System" may help the FDA and drug makers identify medication safety problems much earlier by analyzing patient clinical and claims data.

By Marianne Kolbasuk McGee
InformationWeek
April 16, 2008 03:58 PM

http://www.informationweek.com/news/business_intelligence/mining/showArticle.jhtml?articleID=207300005

I don't work for another pharmaceutical company. I don't have any competing interests. People keep asking me that. Why? Is everything about competition and money? I am getting sick of being asked that.

Frankly, I don't see how anybody could go up against all of the high powered lawyers that Merck can hire. If anybody wanted to speak about how this could happen, Merck would have people going through their doctoral dissertations looking for plagerism. Plaintiffs would have Merck detectives outside their houses hiding in the bushes. Merck private detectives would interview their friends and teachers.

All I wanted to do was to show parents and patients that they are not the only complaints. These complaints have been reported before. Whether they resulted in any serious warnings to Merck doesn't really make a difference because people know how they feel or how their child feels on Singulair.

There is nothing that we can do, in my opinion, but to believe in ourselves. We might trying writing to Queen Beatrix of the Netherlands that the American sufferers must have Dutch brains--which allow montelukast to penetrate the blood brain barrier and can she do anything for us? This is ridiculous that we should be getting these responses from doctors.

From the Netherlands 2006.
In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptoms before they started montelukast, the short latency, and recovery after withdrawal of the drug all strengthen our hypothesis that depressive symptoms are an ADR related to the use of montelukast. According to the Marketing Authorisation Holder of montelukast, depression will be added to the product information.

Mechanism: The mechanism of montelukast-induced depressive symptoms is unknown. However, montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .

http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

I was just asked by Dr. ???, if these European reports lead to change in product information in these countries. I did post that I thought that we should try to find that out. I don't have access to that information. But I do see that the Netherlands did require that depression be added to the product information. It doesn't say the date but Merck agreed.

Artie wanted to tell us about the blood brain barrier. Where are you Artie?

The report says:

In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptoms before they started montelukast, the short latency, and recovery after withdrawal of the drug all strengthen our hypothesis that depressive symptoms are an ADR related to the use of montelukast. According to the Marketing Authorisation Holder of montelukast, depression will be added to the product information.

Mechanism: The mechanism of montelukast-induced depressive symptoms is unknown. However, montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .

From the Netherlands 2006.

This is the html version of the file http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

Page 1
Nederlands Bijwerkingen Centrum LarebMei 2007Montelukast and depressive symptomsIntroductionMontelukast (Singulair®)is a leukotriene receptor antagonist available on the Dutchmarket since 1998. It is indicated for the treatment ofasthma as combination therapy forpatients with light to moderate forms of chronic asthma which cannot be adequately controlledby inhalation corticosteroids and short-acting ß-agonists. For asthma patients for whommontelukast is indicated as asthma treatment it can also relieve symptoms of seasonal allergicrhinitis. Montelukast is also indicated in asthma prevention, if exercise-inducedbronchoconstriction is the main factor

Reports On September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depressive reactions associated with theuse of montelukast.Patient A is a female aged 55 who used montelukast 10 mg once daily for asthma associated with COPD. Concomitant medication included ipratropiumbromideinhalation, salmeterol inhalation, fluticasone inhalation, acetylcysteine, budesonide nose spray and desloratadine. Two weeks after montelukast therapy was initiated the patient experienced nightmares, a depressive symptoms, fatigue and increased dyspnoea. When montelukast was withdrawn, the first three symptoms resolved. It is not known if the dyspnoea resolved. The reporting pneumonologist stated that the increased dyspnoea also could be a sign of progressing COPD. Patient B, reported by a pneumonologist, is a female aged 39 who used montelukast 10 mg once daily for asthma. Concomitant medication included salmeterol/fluticasone inhalation, mebeverine and psyllium seed. One week afterstarting montelukast treatment the patient experienced chest discomfort, malaise,depressive symptoms and dizziness. Montelukast was withdrawn, patient outcomeis unknown. Patient C, reported by a pharmacist, is a male aged 46 who used montelukast 10mg once daily for asthma. Concomitant medication included omeprazole,salbutamol inhalation and budesonide/formoterol inhalation. Six days after starting montelukast treatment the patient got in a depressed state. The patient continued to use montelukast for four weeks but the depression did not resolve. When montelukast was withdrawn, the patient recovered. Patient D, reported by a pharmacist, is a female aged 59 who used montelukast 10mg once daily for mild to moderate asthma. Concomitant medication included mometasone nose spray, salmeterol/fluticason inhalation, oxazepam and paroxetine. Three days after starting treatment with montelukast the patient experienced insomnia and aggravation of her depression. When montelukast was withdrawn the symptoms resolved.

Page 2
Nederlands Bijwerkingen Centrum LarebMei 2007 Other sources of information drugs are known to cause depressive symptoms. However montelukasthas not been associated with depressive symptoms earlier . A Medline searchbased on the MeSH terms montelukast, leukotriens, depressive disorder and mood disorders did not yield any relevant publication. DatabasesOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depression associated with the use ofmontelukast (ROR 2.1 95% CI 0.8 - 5.7). The same day the database of the WHO contained 3466 reports on montelukast, 43 of these concerned depression (ROR1.2 95% CI 0.9 – 1.6)MechanismThe mechanism of montelukast-induced depressive symptoms is unknown.However montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .Discussion and conclusionLareb received four reports of depressive symptoms in patients using montelukast.Possible confounding includes that asthma itself has been associated with the development of depression . Inhalated corticosteroids can also exert effects onthe central nervous system. Fluticason in combination with salmeterol which isused by patients A, B and D, is associated with hyperactivity and irritability where as budesonide, which is used by patient C also has been associated with depression . The latency of montelukast-induced depressive symptoms variesfrom 3-14 days. In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptomsbefore they started montelukast, the short latency, and recovery after withdrawal ofthe drug all strengthen our hypothesis that depressive symptoms are an ADRrelated to the use of montelukast. According to the Marketing Authorisation Holderof montelukast, depression will be added to the product information.

NORWAY:

Here is an example of a very severe reaction to montelukast in 1998. It shows how they investigate adverse drug reactions in European countries. This one is from Norway. It documents the case. Tells about what happened. Gives the supporting evidence. And makes a conclusion.

http://ndt.oxfordjournals.org/cgi/content/full/15/7/1054

If anyone has any access to databases that can describe the history of drug licensing in other countries and whether Merck had to amend product statements, this is worth investigating. I do know that montelukast was at least not initially licensed for seasonal allergies in the United Kingdom when the FDA granted approval in the US. As of 2006, seasonal allergies were not on the approved listed in the UK.

More to add to the files:

Safety of leukotriene antagonists
United Kingdom — The Medicines Control Agency
has published a review of adverse drug reactions to
a new class of asthma drugs, leukotriene antagonists.
Zafirlukast and moltelukast, competitive cysteinyl
leukotriene type-1 receptor antagonists, were
both marketed for the first time in 1998.
Cysteinyl leukotrienes are inflammatory mediators
and potent constrictors of bronchial smooth muscle
that attract human eosinophils and cause airway
oedema, mucus hypersecretion and reduced
mucociliary clearance. By blocking this action, leukotriene
antagonists can improve respiratory function
and lessen symptoms in patients with asthma.
The pharmacological action of leukotrienes is quite
complex and varying side effects have been
reported. Zafirlukast inhibits the hepatic cytochrome
P4502C9, and interacts with warfarin, theophyllin,
terfenadine, acetylsalicylic acid and erythromycin.
Montelukast is metabolized by hepatic cytochrome
P450CYP3A4 and co-administration of such drugs
as phenytoin, phenobarbitone and rifampicin, which
induce this enzyme, result in a marked reduction in
plasma levels.
Side-effects identified during clinical trials were
headache, abdominal pain, nausea, diarrhoea,
gastro-enteritis, influenza, pharyngitis, sinusitis,
cough, nasal congestion, dizziness, fatigue and insomnia.
Since marketing of montelukast, 173 reports
of 317 suspected adverse drug reactions
have been received in the United Kingdom. These
include oedema (50), psychiatric reactions, including
including agitation/restlessness (15), allergy, including
anaphylaxis, angioedema and urticaria (10), chest
pain (7), tremor (5), mouth dryness (5), vertigo (4)
and arthralgia (3).
Reference: Current Problems in Pharmacovigilance,
Volume 24, August 1998.
https://www.who.ch/druginformation/vol12/12-4.pdf

I just got a very condescending private message from a doctor on this site who said that while my articles from Europe are very helpful that I don't know what I am talking about and that I could mislead the public. Then I see how many parents and patients got a condescending attitude from their own doctors.

Well the public has been mislead but it is not my fault. I don't see any experts in this field stepping up to the plate to acknowledge that these side effects exist, have been reported by authorities in other countries, and that these experts are interested in learning why they are happening. This is an extremely widely prescribed medication that involves the lives of millions.

Merck's research director was quoted as saying that they know of no mechanisms by which these side effects could be related to psychiatric adverse drug reactions. That was a flat out LIE. So what if I quoted you a research article from China that was very complicated and yes, could possibly be misinterpreted by somebody? I just needed to give you an example. The only expert so far that had the guts to give you a truthful statement was Dr. J. Douglas Bremner. Thankfully, he corrected a misunderstanding about saying that it was "unclear."

I hope that we will all hang in there and something will be said by somebody, anybody on this site that will make the FDA listen and investigate Singulair (montelukast) all the way back to the very original studies done in test tubes not on people. And, then take a new look at it from the standpoint of what we now know about human genetics. I guess I will keep repeating myself about one size does not fit all.

I would also PRAY that all clinical studies on Singulair (montelukast) would be suspended until the FDA decides why these side effects occur. And that they would issue a statement to doctors to make conservative decisions regarding treatment with Singulair until the results of the investigation have been reported.

I hope that nobody thinks that I am trying to mislead anyone. The answers are either unknown or being hidden by Merck. How would I know the answers? I don't work for Merck. How many other people are out there trying to translate articles in foreign languages to see what's going on? American doctors are calling Merck and being assured that there is nothing to these claims.

I wonder how many experts there are that just don't want to be another Jeffrey Wigand or don't know what is wrong?

I know that I am ranting but somebody should do it.

My 13 year old son has been on Singulair for about 4 years. I considered it a wonder drug because he would always get sick from his asthma. For the past couple of years my son has been very inattentive. I blew it off as the preteen hormones. It wasn't until recently his dad made a comment about him never smiling or enjoying things they use to do together. If you saw any of his recent photos compared to his past pics, he appear dazed and depressed. I would always ask he's okay, any new changes in school. OMG! I can't believe they are marketing this medicine to our children.

He always complained of stomach upsets, really bad headaches every week, pain in his legs and hallucinations. I know this sounds crazy, but I would have never considered it may be the medicine, but after reading the blogs, I'm starting to realize it could be contributed to Singulair. It's been two days since I've taken him off Singulair and I can only hope and pray his asthma does not flair up like it has in the past. I also pray that Merck is reading these blogs and will take Singulair off the market until a more detailed research is conducted. I at one time looked at Singulair as being the greater good for my son's asthma, but it's not worth risking my son's mental health. I wonder if Merck would give this medicine to there children?

Follow up to my post earlier today...

I took the my son to the doctor this morning and he was somewhat dismissive of the recent reports on Singulair...says he's had a lot of kids on the drug and never heard a peep about side effects until last week when the report on suicidal tendencies showed up. He did advise that when these kinds of behavior changes happen after a new drug is started he would recommend that we stop taking the drug no matter what it was, but I still felt uncomfortable with his response to us.

I felt like he was accusing me of making it up or only coming up with it because of recent news and message board posts. In fact, I made the appointment BEFORE I saw the posts. I was worried about his behavior BEFORE I saw the posts. It's just that seeing the stories from everyone else basically confirmed my suspicions that it might be the drug causing the problems.

I feel like I definitely wasted OVER AN HOUR waiting for a doctor to spend five minutes making me feel small.

Last night was the last time my son will take the drug, and I don't care what the doctors think of me.

I know that many here would like the FDA to take a very serious took at the problem. I personally don't see how a review of their data is going to make any difference at all. But, if there are experts who can propose a model of the pathways of cell signalling that include the possibility that these symptoms can occur (and under what circumstance), then maybe the problem will look like something much more than statistics.

This is not my field. But I tried to follow the possible pathways to see if I could identify a possible area of concern. Then I looked for someone who had written in the area and read their abstract. A place to start may be to get an opinion from those who know something about "normal homeostasis of the mast cell." Singular blocks the cysteinyl leukotriene receptor 1 which is a site on the outer membrane of the mast cell (other cells also). The mast cell which is produced in the bone marrow is released in a immature state and matures after it arrives at it's destination. The mast cell does not become active unless it's receptor sites come in contact with the activating agent. So, what happens when a receptor site on the mast cell is suppressed by Singular, a receptor antagonist.

You see, I don't have a clue what the signals are that tell the bone marrow to make mast cells (or what the signals are that tell them where to go after they are made in the bone marrow). Does Singular interfere with something that tells the bone marrow what to do? If Singular does interfere with that process, then what is happening and what period of time does it take to happen? Could we wonder whether Singular is interfering with the NUMBER of mast cells that are produced over time? And, of course, maybe there is some OTHER kind of explanation for why the adverse drug reactions are happening. But, at this level, I got lost and can't go any further.

Maybe this group would be interested in the Singulair problems or could suggest somebody else?

http://www.edata-center.com/journals/2ff21abf44b19838,0a1257122f661a7e,0d8ee7116ef23452.html

I apologize if this lead doesn't produce any results but at least it could be a place to start.