Food and drug administration symptoms and conditions

I URGE YOU TO PLEASE SUBMIT ANY ADVERSE EVENTS OF THIS TERRIBLE KENALOG DRUG TO THE FDA--JUST CLICK THIS LINK AND COMPLETE THE FORM: http://www.fda.gov/medwatch/. The FDA is responsible for assuring safety of medications. Therefore, it is imperative that the FDA recognize the adverse effects to provide any credibility to a class action suit. Please consider forwarding your case to the FDA to force them into action and begin addressing these atrocities.

Here's my case: I am also a victim of having the Kenalog injection administered over a year ago to alleviate poison ivy itching symptoms. Prior to having the injection, I was not informed of any side effects. Not only did the injection not alleviate the symptoms, but has resulted in a discolored and uncomfortable indentation in my left buttock area and psychological anguish because of disfigurement of my body. It is over a year later and the indent remains and continues to cause discomfort. The dermatologist who administered the injection stated that there was nothing I could do to reverse such effects. I reported my case to the FDA (Food and Drug Administration) Med Watch and strongly urge others to report their adverse event to the FDA (see link above).

Commenting on the post earlier today. I decided to look into the Norplant (see below for more details) Now i found that development of my Mirena was done in part by the maker of the Norplant? Which has been pulled in the US and the UK after 50,000 people filed a class action suit (which was settle out of court)

Development and studies of the Mirena Coil began in the 1970s. Schering Health distributes Mirena outside the United States, while Berlex distributes it inside the United States. Both companies have worked with the Population Council, a that has worked with other contraceptive manufacturers (including Wyeth, maker of Norplant).
Mirena was first marketed commercially in Finland in 1990, but not approved by the U.S. Food and Drug Administration until 2000. It is intended to initially release 20 micrograms of levonorgestral per day and may be used for five years. Sound familiar?
Norplant is a form of birth control was first approved in 1983 in Finland. The original Norplant consisted of a set of six small (2.4 mm x 34 mm) silicone capsules, each filled with 36 mg of levonorgestrel (a progestin used in many birth control pills) implanted subdermally in the upper arm and effective for five years. The original (6 capsule) Norplant's production has been phased out; USAID's contract ran until December 2006.
The original (6 capsule) Norplant was approved by the FDA in 1990 and marketed in the United States in 1991 by Wyeth Pharmaceuticals. Norplant distribution in the United States ended in 2002; limited supplies still remained in the U.S. until 2004. Norplant was withdrawn from the UK market in 1999.
Side effects
After three months of using Norplant, women will need to schedule a follow-up appointment to monitor blood pressure and discuss any concerns. Side effects may include irregular menstrual periods for the first approximately three months, including periods lasting longer than normal, bleeding or spotting between periods, heavy bleeding, or going with no period for the mentioned period of time. Common side effects include weight gain, nervousness, anxiety, nausea, vomiting, mastalgia, dizziness, dermatitis/rash, hirsutism, scalp-hair loss, headache, depression, and acne. Sometimes, pain, itching or infection at the site of the implant will occur. Ovarian cysts may also occur, but usually do not require treatment, although they can cause pain even if benign.
Norplant discontinued in the United States
By 1996, more than 50,000 women had filed lawsuits, including 70 class actions, against Wyeth and/or its subsidiaries, or doctors who prescribed Norplant. Wyeth never lost a Norplant lawsuit.
On August 26, 1999, after winning 3 jury verdicts, 20 pretrial summary judgments and the dismissal of 14,000 claims, Wyeth offered out-of-court cash settlements of $1,500 each to about 36,000 women who contended that they had not been adequately warned about possible side effects of Norplant such as irregular menstrual bleeding, headaches, nausea and depression. Wyeth said that most of the plaintiffs experienced routine side effects described in Norplant's labeling information. About 32,000 women accepted the out-of-court $1,500 settlements.
At least they warned the user of these side effects and the no longer offer Norplant in the US

October 2, 2008, 7:26 pm
FDA Contract: Prescription for a Big Headache
Alicia Mundy reports on drug regulation.

It’s unusual for a regulator and the industry it regulates to share the same public relations firm.

But that’s just what’s happened with the Food and Drug Administration and the pharmaceutical industry’s lobbying arm.

Qorvis Communications, an influential PR group in Washington, was hired this year by the FDA as a subcontractor to help heal the agency’s ailing image with a $300,000 “FDA 2008 Public Awareness Campaign.” Qorvis, however, has been working for the Pharmaceutical Research and Manufacturers of America, the Washington-based lobby for drug makers, since 2006.

Ironically, the FDA has been under fire for being too lax in enforcing drug safety regulations with PhRMA’s members – and the big effort to burnish its reputation has backfired.
Qorvis also has been representing UST Inc., whose U.S. Smokeless Tobacco unit is the largest American maker of chewing tobacco, which supports a controversial bill in Congress that would allow the FDA to regulate the tobacco industry. The FDA commissioner has opposed the bill. UST is being acquired by Altria Group...........................this was in yesterdays Wall Street Journal...maybe if they did their job right they wouldn't need a publi relations group to up its image,maybe if they separated themselves from the drug companies we would believe them

WASHINGTON, Sept 17 (Reuters) - The U.S. Food and Drug Administration appears to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers, a top Democratic lawmaker said on Wednesday.

The head of the U.S. House of Representatives Oversight and Government Reform Committee questioned how the FDA set its priorities given recent controversies over its handling of safety issues, including tracking tainted foods and inspecting drug manufacturers.

A 2007 list of top projects includes plans to offer advice to companies on promoting products, as well as guidance on offering reprints of journal articles to physicians, California Democrat Henry Waxman said in a letter to FDA Commissioner Andrew von Eschenbach.

The agency also planned to change its regulations to protect device makers from lawsuits as long as their products are FDA-approved with a so-called preemption clause.

"All appear to prioritize industry desires over consumer protection," Waxman wrote.

The FDA has come under fire in recent years following a string of highly-publicized safety scares, starting with the 2004 withdrawal of Merck & Co Inc's (MRK.N: Quote, Profile, Research, Stock Buzz) painkiller Vioxx following heart problems.

The risk of suicide with antidepressants and other drugs, as well as tainted batches of blood-thinner heparin and bacteria-laced produce such as spinach and hot peppers have also fueled concerns.

Asked if it had any response, FDA spokeswoman Heidi Rebello said the agency would comment directly to Waxman
THE DAYS OF RECKONING ARE COMING

I am also a victim of having the Kenalog injection administered over a year ago to alleviate poison ivy itching symptoms. Prior to having the injection, I was not informed of any side effects. Not only did the injection not alleviate the symptoms, but has resulted in a discolored and uncomfortable indentation in my left buttock area and psychological anguish because of disfigurement of my body. The dermatologist who administered the injection stated that there was nothing I could do to reverse such effects. I reported my case to the FDA (Food and Drug Administration) Med Watch. I urge others to report their adverse event to the FDA--just click on this link and complete the form: http://www.fda.gov/medwatch/. The FDA is responsible for assuring safety of medications. Therefore, it is imperative that the FDA recognize the adverse effects to provide any credibility to a class action suit. Please consider forwarding your case to the FDA to force them into action and begin addressing these atrocities. Such documented cases and recognition by the FDA will provide leverage for attorneys in pursuit of a class action suit.

Sales of Merck's asthma and allergy drug Singulair dropped 1% to $1.1 billion for the second quarter. U.S. sales have been hurt by the recent introduction of an over-the-counter version of rival drug Zyrtec by Johnson & Johnson (JNJ), as well as concerns about the Food and Drug Administration's March alert of a possible association between Singulair and suicide and related behavioral side effects Got this off cnn money,i don't know but thought zyrtec and singulair were different drugs,my son at one time was prescribed both to take at bedtime

The following article in the WSJ may explain the reason for the significant number of Adverse Reactions to statin drugs.

Why You Can't Tell Where
Your Medication Was Made
April 8, 2008; Page D1- Wall Street Journal
Bananas come with those little stickers listing their country of origin. Why not pharmaceuticals?
That's what some consumers -- and even some physicians -- are asking since the Food and Drug Administration linked the deaths of 19 people to contaminated batches of the blood thinner heparin from China.
*******

I encourage every patient with a bad experience taking statins to contact the FDA (see, July 1, 2008 posting for FDA contact info).

The following article in the WSJ may explain the reason for the significant number of Adverse Reactions to statin drugs.

Why You Can't Tell Where
Your Medication Was Made
April 8, 2008; Page D1- Wall Street Journal
Bananas come with those little stickers listing their country of origin. Why not pharmaceuticals?
That's what some consumers -- and even some physicians -- are asking since the Food and Drug Administration linked the deaths of 19 people to contaminated batches of the blood thinner heparin from China.
******

I encourage every patient with a bad experience taking statins to contact the FDA (see, June 29, 2008 posting for FDA contact info).

Saw this story on CNN today. Guess we aren't all tinfoil-hat wearing nutcases after all.

******

FDA orders 'black box' label on some antibiotics

The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendinitis.
Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.

The consumer group Public Citizen asked the FDA in August 2006 to put the "black box" warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.

When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.

"There has been ongoing work to update the labeling of the fluoroquinolone drug products," Cox said. "We have been working on this issue and making progress over time."

The companies that make the fluoroquinolone drugs will be required to submit label safety changes and the medication guide within 30 days of receiving the notification from the FDA or provide a reason why they do not believe such labeling changes are necessary, Cox said.

The fluoroquinolones drugs can increase the risk of tendinitis and tendon rupture -- which is about 1 in 100,000 -- by three to four times, according to the FDA's Dr. Renata Albrecht.

"This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," the FDA said in a statement.

Albrecht said that sometimes patients have no symptoms before they experience a rupture in their tendon -- commonly their Achilles tendon.

"Sometimes it's been reported on the first day of taking a fluoroquinolone ... a sudden snap or popping sound that is tendon rupture with no preceding warning," she said.

Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."

The FDA would only say that it has received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Patients should stop taking fluoroquinolone antibiotics at the first sign of tendon pain, avoid exercise and contact their doctor, the FDA said.

Cox said the FDA would not require companies to send letters to doctors alerting them about the connection between tendon problems and the antibiotics.

"It is possible under REMS to ask for a letter ," Cox said. "Certainly for sponsors that would choose to go forward with a letter, we'll be happy to work with them."

I have taken 4 doses of Fosomax-1x a week - and have noticed weight gain, nausea and lethargy. After the first three doses noticed a mild headache, which I blamed on my sinuses. After this last dose ( taken 6 days ago), I have had an excruciating headache, and facial pain. I have a constant burning feeling in my stomach. I will not take another dose. I saw that someone had previously mentioned taking Bone Up, and had good results. Has anyone else tried this? As a breast cancer survivor with borderline osteoporosis I am looking for a good alternative.

I am in the family with the 86 year old man that committed suicide because of this drug. He was my father and I will never be able to see him again. This drug caused such severe side effects for him that he did not know what he was doing and killed himself leaving his wife of 59 years, 7 children and a host of grandchildren and great-grandchildren. He had everything to live for and had no effects of depression or other problems until he started taking the medicine. The drug made him sicker instead of better. My family has asked that we received a drug screening from the Medical Examiner to determine the combination of drugs that were in my dad's system at his death. He was also prescribed prednisone, which we have since found out should that the drugs should not have been given together. I would like to take this doctor to task for his incompetence in prescribing an elderly man medication that could cause this result. I am very angry at the physician and will pursue legal actions when we receive the Medical Examiners information. No family should have to suffer the loss that we have had and no experience the void that we have in our lives. My father was a healthy, 86 year old man with a family history of living past the age of 100. We figured he had another 20 years to go. I know that my taking legal action will not bring back my father but I would like to somehow make this drug side effects public knowledge so this DOES NOT happen to another family. This weekend is Father's Day and my only way to talk to my father is standing my his graveside. I should not be doing that. I should be celebrating another Father's Day with him at his home. This drug and his doctor caused his death. DO NOT TAKE THIS DRUG....consult your doctor if he even mentions it in a course of treatment. I would like to be able to present evidence to the Food and Drug Administration of the terrible effects of this drug and the combination of drugs that are given with it. My daughter even said she would like to be the one presenting our family story to Congress during hearing concerning removing this drug from the market. That is my goal....this drug should be removed. I have contacted the Food and Drug Administration and suggest that everyone else do the same. If they get enough complaints, they will have to open a dialog on the drug and some of the families will have the opportunity to speak about the effects of the drug on their lives. I will always miss my father and love him dearly. I know that he was not in his right state of mind when he committed suicide and that the drug caused his actions. My mother found him that day in April when she came home from the store. She will never be the same nor will our family. Again, DO NOT TAKE THIS DRUG!!!!!

I am also a victim of having the Kenalog injection administered over 8 months ago to alleviate poison ivy itching symptoms. Prior to having the injection, I was not informed of any side effects. Not only did the injection not alleviate the symptoms, but has resulted in a discolored and uncomfortable indentation in my left buttock area and psychological anguish because of disfigurement of my body. It is 8 months later and the indent appears to continue to deepen and lengthen. The dermatologist who administered the injection stated that there was nothing I could do to reverse such effects. I reported my case to the FDA (Food and Drug Administration) Med Watch. I urge others to report their adverse event to the FDA--just click on this link and complete the form: http://www.fda.gov/medwatch/. The FDA is responsible for assuring safety of medications. Therefore, it is imperative that the FDA recognize the adverse effects to provide any credibility to a class action suit. Please consider forwarding your case to the FDA to force them into action and begin addressing these atrocities. Such documented cases and recognition by the FDA will provide leverage for attorneys in pursuit of a class action suit.

I have taken Flomax for three nights. Each night, I woke up after having a disturbing and rather intense dream. This kind of dream was something that might happen once per year. Three nights in a row is very unlikely to be an accident.

I WILL NEVER TAKE THIS CRAP AGAIN!

Of the last four medications I've taken, three caused unacceptable side effects!

Gosh... this is such a big surprise. I have recently read that pharmaceutical companies have been tampering with the results of drug studies. They also have a "buddy-buddy" relationship with the Food and Drug Administration and some members of congress.

I can't wait for November 2008 to vote against the regime that is in power and which allowed this kind of farce to occur in agencies that are supposed to help protect Americans from crappy "medicines".

Fluoride supplements put children six and under at significant risk of permanently discolored teeth, according to a review of studies recently posted on the American Dental Association’s (ADA) web site in their new section, “evidence-based dentistry,” for dentists and their patients. (1)

Fluoride supplements, in graduating amounts up to 1 mg daily, are often prescribed to children who don’t drink fluoridated water, ostensibly to reduce tooth decay.

“This review confirmed that in non-fluoridated communities the use of fluoride supplements during the first 6 years of life is associated with a significant increase in the risk of developing dental fluorosis, write researchers Ismail & Bandekar and first published in Community Dentistry and Oral Epidemiology, February 1999, (2) but posted to the ADA’s website July 2007.

Fluoride ingestion, once thought to reduce cavities, can lead to dental fluorosis – white spotted, yellow, brown and/or pitted tooth enamel. Modern science indicates fluoride absorbs into tooth enamel topically, primarily.(3)

Studies link dental fluorosis to children’s kidney damage (4) and bone fractures (5).

The ADA and Centers for Disease Control recently advised that fluoridated water should not be mixed into concentrated infant formula, in order to decrease dental fluorosis risk – now a growing U.S. problem. (6)

Never safety-tested by the U.S. Food and Drug Administration) (7), fluoride supplements do more harm than good.(8)

“While fluoride is proclaimed a significant cavity reducer, there is little, if any, science to support that," says lawyer Paul Beeber, President, New York State Coalition Opposed to Fluoridation.

A National Institutes of Health 2001 news release supports Beeber's assertion: "... the (NIH) panel was disappointed in the overall quality of the clinical data that it reviewed. According to the panel, far too many studies were small, poorly described, or otherwise methodologically flawed." (9) Over 560 studies evaluated fluoride among those reviewed by the NIH Consensus Development Program panel for the Diagnosis and Management of Dental Caries.

Recent research shows that fluoridation delivers risks with little, if any, benefit.(10)

References:
1) http://www.ada.org/prof/resources/ebd/reviews/fluoride_supplements.asp

2) "Fluoride supplements and fluorosis: a meta-analysis," Community Dentistry & Oral Epidemiology, 1999 Feb;27(1):48-56, by Ismail & Bandekar .

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10086926

3) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm

4) "Dose-effect relationship between drinking water fluoride levels and damage to liver and kidney functions in children," Environmental Research,2007 Jan;103(1):112-6. Epub 2006 Jul 10, by Xiong, et. al http://tinyurl.com/34lj92

5) "Dental and Early-State Skeletal Fluorosis in Children Induced by Fluoride in Brick-Tea," Fluoride 2005;38(1):44–47 Cao, et. al

http://www.fluorideresearch.org/381/files/38144-47.pdf

6) http://www.cdc.gov/mmwr/preview/mmwrhtml/figures/s403a1t23.gif

7) http://fluoridedangers.blogspot.com/2005/12/fluoride-never-fda-approved-for.html

8) "The case for eliminating the use of dietary fluoride supplements for young children," Journal of Public Health Dentistry, Fall 1999, by Burt

http://tinyurl.com/2bnoff

9) http://consensus.nih.gov/2001/2001DentalCaries115html.htm

10) "Community Water Fluoridation and Caries Prevention: A CriticalReview," Clinical Oral Investigations, by Pizzo et.al, 2007 Feb 27;
http://www.newmediaexplorer.org/chris/Pizzo-2007.pdf

Fluoride supplements put children six and under at significant risk of permanently discolored teeth, according to a review of studies recently posted on the American Dental Association’s (ADA) web site in their new section, “evidence-based dentistry,” for dentists and their patients. (1)

Fluoride supplements, in graduating amounts up to 1 mg daily, are often prescribed to children who don’t drink fluoridated water, ostensibly to reduce tooth decay.

“This review confirmed that in non-fluoridated communities the use of fluoride supplements during the first 6 years of life is associated with a significant increase in the risk of developing dental fluorosis, write researchers Ismail & Bandekar and first published in Community Dentistry and Oral Epidemiology, February 1999, (2) but posted to the ADA’s website July 2007.

Fluoride ingestion, once thought to reduce cavities, can lead to dental fluorosis – white spotted, yellow, brown and/or pitted tooth enamel. Modern science indicates fluoride absorbs into tooth enamel topically, primarily.(3)

Studies link dental fluorosis to children’s kidney damage (4) and bone fractures (5)

The ADA and Centers for Disease Control recently advised that fluoridated water should not be mixed into concentrated infant formula, in order to decrease dental fluorosis risk – now a growing U.S. problem. (6)

Never safety-tested by the U.S. Food and Drug Administration) (7), fluoride supplements do more harm than good.(8)

“While fluoride is proclaimed a significant cavity reducer, there is little, if any, science to support that," says lawyer Paul Beeber, President, New York State Coalition Opposed to Fluoridation.

A National Institutes of Health 2001 news release supports Beeber's assertion: "... the (NIH) panel was disappointed in the overall quality of the clinical data that it reviewed. According to the panel, far too many studies were small, poorly described, or otherwise methodologically flawed." (9) Over 560 studies evaluated fluoride among those reviewed by the NIH Consensus Development Program panel for the Diagnosis and Management of Dental Caries.

Recent research shows that fluoridation delivers risks with little, if any, benefit.(10)

“Save money, save our health, save the planet. Stop fluoridation,” says Beeber.

references:

1) http://www.ada.org/prof/resources/ebd/reviews/fluoride_supplements.asp

2) "Fluoride supplements and fluorosis: a meta-analysis," Community Dentistry & Oral Epidemiology, 1999 Feb;27(1):48-56, by Ismail & Bandekar .

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10086926

3) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm

4) "Dose-effect relationship between drinking water fluoride levels and damage to liver and kidney functions in children," Environmental Research,2007 Jan;103(1):112-6. Epub 2006 Jul 10, by Xiong, et. al

http://tinyurl.com/34lj92

5) "Dental and Early-State Skeletal Fluorosis in Children Induced by Fluoride in Brick-Tea," Fluoride 2005;38(1):44–47 Cao, et. al

http://www.fluorideresearch.org/381/files/38144-47.pdf

6) http://www.cdc.gov/mmwr/preview/mmwrhtml/figures/s403a1t23.gif

7) http://fluoridedangers.blogspot.com/2005/12/fluoride-never-fda-approved-for.html

8) "The case for eliminating the use of dietary fluoride supplements for young children," Journal of Public Health Dentistry, Fall 1999, by Burt

http://tinyurl.com/2bnoff

9) http://consensus.nih.gov/2001/2001DentalCaries115html.htm

10) "Community Water Fluoridation and Caries Prevention: A CriticalReview," Clinical Oral Investigations, by Pizzo et.al, 2007 Feb 27;
http://www.newmediaexplorer.org/chris/Pizzo-2007.pdf

I too, have been having weird symptoms over the last several months and just connected it all with having a Kenalog shot 7 months ago. In October 2007, two months after my injection, I developed severe anxiety and panic attacks. I thought it was related to perimenopause. Then, in January, I started having lots of muscle and joint pain all over my legs and hips. I've been a healthy and active person, so this was very unusual. I saw an orthopeadic surgeon who diagnosed me with a strained rotator cuff and bursitis on my hips. Now, just two weeks ago, I woke up with a large indentation on my left glut. Right where the Kenalog injection was given. My doctor had no clue what it was and said she might refer me to a Plastic Surgeon. I am SO relieve to find this board. It all clicked when I read everyone's postings. Now I just want to know if it will get worse or eventually go away. I did find some interesting information about the drug. BTW, the nurse or doctor NEVER said anything about side effects before giving my the injection. I am seriously going to pursue a law suit, so we can get this terrible drug OFF the market and no one else has to endure this disfiguring problem. If ENOUGH of us join together in a law suit, it might be worth suing the drug manufacturer. But we have to somehow get organized. Anyone intersted in pursuing this?

Here are some facts about the drug I found online.

Kenalog is not appropriate for everyone. A thorough medical history should be assessed prior to prescribing this medication. Patients with a medical history which includes skin infection, tuberculosis of the skin, chicken pox, herpes, cold sores, sunburned or wind burned skin, chapped skin, open sores, diabetes, or a stomach ulcer may not be able to take Kenalog or may require careful monitoring while undergoing drug therapy with this medication, depending on the condition and the severity of the condition.

The American Food and Drug Administration rated Kenalog as a pregnancy risk category C. This medication has been known to cause harm or birth defects in unborn babies. It has yet to be determined whether or not Kenalog passes through the mother’s breast milk and affects a nursing baby. The prescribing physician should avoid prescribing this medication to women who are pregnant, nursing, or have a high likelihood of becoming pregnant.

There is a risk of side effects associated with Kenalog, some of which are severe. A patient who is experience a serious side effect or an allergic reaction should seek immediate emergency treatment. An allergic reaction will present with symptoms which may include facial swelling, such as swelling of the lips, mouth, tongue, or throat, hives, and difficulty breathing. Other serious side effects which require immediate emergency medical treatment include symptoms such as insomnia, blurry vision, mood changes, halo vision, fatigue, weight gain, facial puffiness, or irregular heart rate.

WASHINGTON (Reuters) - U.S. health regulators are probing a possible connection between Merck & Co Inc's blockbuster Singulair asthma drug and suicidal behavior in adults and children, the Food and Drug Administration said on Thursday.

The persons who have no symptomatic effects are so fortunate with Singulair. A medicine out in circulation abusing one's emotions, lifestyle, threatening life is a circumference, detrimental side effect.

I have read everyone's symptoms that have written their concerns on this website and I want to recommend that you contact the U.S. Food and Drug Administration website at: www.fda.gov and it will give you all the information you need on the side effects of this drug.

Believe me, many of the symptoms you have all described are on their list under the section that I browsed through when I looked up Lisinopril/HCTZ or ZESTORETIC (the generic kind of this drug).

This what I found:

ADVERSE REACTIONS

ZESTORETIC has been evaluated for safety in 930 patients including 100 patients treated for 50 weeks or more.

In clinical trials with ZESTORETIC no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.

The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of lisinopril and hydrochlorothiazide were: dizziness (7.5%), headache (5.2%), cough (3.9%), fatigue (3.7%) and orthostatic effects (3.2%) all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature, but see WARNINGS regarding angioedema and excessive hypotension or syncope. Discontinuation of therapy due to adverse effects was required in 4.4% of patients principally because of dizziness, cough, fatigue and muscle cramps.

Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in controlled clinical trials are shown below.

Table Percent of Patients in Controlled Studies

(For a more detailed breakdown of this chart, pls. check the fda website)

Incidence (discontinuation)

Dizziness 7.5
Headache 5.2
Cough 3.9
Fatigue 3.7
Orthostatic Effects 3.2
Diarrhea 2.5
Nausea 2.2
Upper Respiratory Infection 2.2
Muscle Cramps 2.0
Asthenia 1.8
Paresthesia 1.5
Hypotension 1.4
Vomiting 1.4
Dyspepsia 1.3
Rash 1.2
Impotence 1.2

Clinical adverse experiences occurring in 0.3% to 1.0% of patients in controlled trials and rarer, serious, possibly drug-related events reported in marketing experience are listed below:

Body as a Whole: Chest pain, abdominal pain, syncope, chest discomfort, fever, trauma, virus infection. Cardiovascular: Palpitation, orthostatic hypotension. Digestive: Gastrointestinal cramps, dry mouth, constipation, heartburn. Musculoskeletal: Back pain, shoulder pain, knee pain, back strain, myalgia, foot pain. Nervous/Psychiatric: Decreased libido, vertigo,
depression, somnolence. Respiratory: Common cold, nasal congestion, influenza, bronchitis, pharyngeal pain, dyspnea, pulmonary congestion, chronic sinusitis, allergic rhinitis, pharyngeal discomfort. Skin: Flushing, pruritus, skin inflammation, diaphoresis, cutaneous pseudolymphoma. Special Senses: Blurred vision, tinnitus, otalgia. Urogenital: Urinary tract infection.

Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely. (See WARNINGS.)
In rare cases, intestinal angioedema has been reported in post marketing experience.

Hypotension: In clinical trials, adverse effects relating to hypotension occurred as follows: hypotension (1.4%), orthostatic hypotension (0.5%), other orthostatic effects (3.2%). In addition syncope occurred in 0.8% of patients. (See WARNINGS.)

Cough: See PRECAUTIONS - Cough.

I found this website to be helpful information in trying to find out more about the side effects I have been experiencing after taking this drug. I also wrote in to the U.S. Food and Drug Adminstration with my concerns to see what we can do to get it off the market or have it improved.

There is alot more information about the drug and its generic brand as well, but I thought this was important to put on this website. Hope this helps!

Martha

To everyone who has posted here I would like to let you know that most of the symptoms you are complaining of are listed on the United States of America Food and Drug Administration web site (google search fda) as side effects of Warfarin. Also is listed the drugs that will interact badly with Warfarin like steroids with my doctor put me on. It is a hard site to navigate my wife and I spent 4 hours finding all the information I needed to print and can now stuff it in my "it cant be the Warfarin" doctors face and ask him why he has not done his homework on this very dangerous medication. Please remember that your doctor is YOUR employee. I hope this helps all of you as I feel your pain having shared many of your side effects myself.

Jimmy

My son will be 4 next month he was only on Singulair for a month and a half to control his asthma and it has been such a stressful and sad nightmare for me as his mom. He was always been a smart and sweet kid, really calm and had a great attention span now after Singulair I feel like someone took my son and I can't get him back. His behavior is sporadic he has no attention span he can't sit still he has had leg pain, no appetite, not even for his favorite foods. He is about to be kicked out from his preschool because he has shown heightened levels of aggression for no reason and I don't know what to do. The pediatrician tells me that he has been off it for 9 days and it should be out of his system I don't believe it and I'm wondering when my son will be normal again. I feel terrible disciplining him because I feel like its not his fault its this medication that I didn't want to give him in the first place and I regret trusting her because of what its done to my son. There has to be a way to issue some kind of warning or lawsuit against this company this medication is NOT FOR CHILDREN! Please don't give it to your children.

My 7year daughter has been taking Singulair for 3 years. I cannot believe that her symptoms that she has been having is just like all the others. I did not know what was causing it until finding this site. I believe that it is Singulair. She get very emotional and cries over the littlest things, seems depressed sometimes, wakes up itching, headaches especially at night, and the last few days she is like having anxiety attack . She doesn't want to go to school anymore and she has always loved school. Her heart has been racing and she shakes. I took her to the ER and they did an ekg, blood work. Could not find anything wrong. They said it sounds like a drug reaction or side effect. She was taking Palgic antihistamine, and Singulair. He told me to take her off the Palgic. He said he thought it was causing the heart to race. She is not any better. Know I am wondering if it is the Singulair. I guess I will be taking her off it to see if she improves.

Hi,

I had a systemic allergic reaction to an allergy injection. I was treated at the hospital with Benadryl and Prednisone. I was told to continue to take both, but still was having problems with sinus inflammation related to the reaction a day later. I saw my Dr. who told me to up the Prednisone and start taking Singulair.

Well I started having side effects worse than the sinus inflammation I originally had within a few hours of taking the Singulair. I totally chalked them up to Prednisone side effects, since that drug has so many issues. But the side effects were different than those listed from Prednisone, and different from the last time I had to take Prednisone for an allergy attack. I had INTENSE head pressure (not just the sinuses, but everywhere), muscle tightness/pressure in my neck muscles and at the base of my skull. I don't know if this was a side effect or not, but I had freezing hands and feet, also VERY cold.. except my face was hot. I also got hot flushes occasionally in my body, like on the backs of my thighs. I also felt "out of it".. very dizzy and slow to respond. I was also very confused by why my sinus inflammation was not really responding to the Prednisone since it is such a strong anti-inflammatory. Well, I stopped taking the Singulair last night after reading this site, and I am feeling back to normal! Even my sinuses have unplugged. I suppose this could all be something besides the Singulair, but I am not chancing it again.

i posted in august but am reposting with more information on how to report your side effects to the FDA .It is a site called Medwatch.com and they want to know these adverse reaactions.We are the people that lost our son to a suicide after he was given this drug for 17 days.Our son was a lovable well adjusted soon to be 16 year old .He had a terrible advers reaction to this drug having extreme anxiety, moodiness,agitation and depression.We did not of course have the proper knowledge about this drug to know that he was having an adverse event.We are working with our local senator and assemblywoman to contact a Dr Malson at the FDA he is the director of research and drug evaluation.The information pamplet from the pharmacy did not mention these side effects or we would have realized what was happening.We are trying to get a black box warning on the drug to let people especially parents of children know exactly what this drug is capable of.TAKE ACTION AND CONTACT THE FDA THIS IS HOW A DRUG GETS REEVALUATED!We wish we had found this site while our beautiful boy was still alive .Our child had a normal life and no emotional problems and after taking this poison he had a complete psychological breakdown,the address to writ aletter to tell your story is Steven K.Malson,MD,MPH Director Center For Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857. PLEASE HELP THIS DRUG NEEDS SPECIAL LABELING

I have been on lipitor for a little over two years now. I experience extreme joint and muscle discomfort. I am also picking up weight at an alarming rate. No matter what I do to lose the weight, it's not working. I've had several blood tests, but all come back fine..but I know I don't feel well and I'm having trouble remembering things....