Drug safety symptoms and conditions

I was given Singulair a week ago when I went in for bronchitis. I have noticed I do stay tired all the time & that I've become more disconnected from emotions. I am normally a very sensitive person, and it's not that its been an extreme change, but the change is there and I don't like it. I also have had to continue using my inhaler due to tightness that the Singulair does not completely get rid of for me. Yesterday, I was having dinner when my head just spun. I grabbed my composure and was ok as long as I stayed more relaxed & didn't talk a lot. I have terrible allergies and I knew that my bronchial tubes were constricted very tight & that was the cause for dizziness. This morning, my lips were starting to swell and I was starting to feel the puffiness in my eyes. I wanted to know if I could take benadryl w/ Singulair & came across this site. I took the benadryl I feel much, much better. Seems to me that if Singulair is supposed to control the tightness I would be getting better, Not worse. I have made up my mind to stop the Singulair & will contacting my doctor for something different to help with bronchial contrition.

Thank you all for sharing your experiences.
R. in Tx

My 4 year old son started taking singulair when he was two. I don't think I picked up on his behavior change right away b/c I thought that he was just entering the "terrible two's". But over time, his allergist added on Nasonex (I know the docs say that it doesn't cause side-effects b/c it's a nasal spray, but I don't buy that...it's a steroid, plain and simple) and more recently zyrtec was added on for his hives. Well, the zyrtec was the straw that broke the camel's back. I mean, he has been a real "handful" since the singulair, but after zyrtec was added 5 months ago - let's just say he was completely out of my control. His meltdowns were so bad that I couldn't go ANYWHERE with him. I either got a sitter or just didn't go anywhere. He became aggressive, defiant, emotional, unhappy. And to top it off he started to have serious "autistic-like" self-stimulatory behaviors (grinding teeth, squinting eyes shut, flapping his hands, punching himself...). At this point my life had become a complete nightmare, and my poor 10 month old son was getting NO attention b/c my 4 year old was so out of control and aggressive. I was afraid for the baby's safety...oh, I could go on all night. This medication has impacted my marriage, my finances, my sanity. Shortly after he started Singulair I had to go on an antidepressant b/c it too so much out of me just to be his mommy. Anyway, a week ago I had him scheduled for a psych evaluation (thought for sure we were going to walk away with either autism or bipolar diagnosis), but two days before I decided to look up the meds he is on and BINGO! All of these posts sound like what we have been going through. I stopped all of his meds that night, cold-turkey, and he has been the most pleasant little boy I have ever met!! My husband and I have fallen in love with him over the past week - we had no idea he was such a sweet child.

Now, while I'm ecstatic that we have found the answer to our nightmare, I also feel SO STINKIN' ANGRY! We lost out on 2 years with our sweet boy, there were times when we raised our voices at him when he just couldn't help himself - he was suffering inside!! When I went to talk to the allergist about my findings this past week, he said, "well, maybe he just had a good day. I'd like to see what happens if he goes off all his meds for a week". Well, there you have it, he has been off for one week and he's an absolute angel. He has an amazing heart and is so caring!!!

Singulair is awful (and so is zyrtec). Please don't give this drug to your children. Research other alternatives (I am giving my son Nordic Naturals Fish Oil, Culturelle probiotics, vitamin c, and am changing his diet - increased magnesium and decreased dairy. I came up with this after hours of research...).

There is a woman on this site whose daughter committed suicide after 3 years on Singulair. This is no joke and the FDA needs to get with it.

BTW, I used to date a Singulair rep (I knew there was something I didn't like about that guy:)

I took Levaquin 750 for 10 days for a sinus infection. I took first 5 doses, went to see my doctor again 6 days later because I was still sick. She prescribed again 5 does of Levanquin 750. I am still coughing and I feel very tired. It did not help at all. I am still sick and I have muscle pains in my two calves and stress Achille tendon. I am a runner and I have sometimes problems with my calf: I have been not running too much recently and I was wondering how come suddenly I had those muscle pains in both my calves. I am not sure if it is related to Levaquin, but when I read all those comments, I am worried. Why I have been prescribed this antibiotics if it is obviously dangerous?

On the fda;s cder web site is a calender of meetings,there is also a calender for tentative meetings,tentively scheduled on dec 10 and 11 is a meeting of asthma allergy,risk management and drug safety,we know they hired public relations so we wonder if maybe they will be there,as this investigation comes to an end,i wonder is there more we could have done,i don't think so,i am perturbed that we were not contacted after we filed our reports,as i wonder how they will get the rest of the story.It is my understanding that these meetings are open to the public,unless otherwise specified,there is no specification on this one yet,i hope if any one is in the Dc area and they have a chance to go they will tell us what is said.I hope they look into the chances of some having maybe perm issues and give us guidance,they have been silent for so long as we have battled this in the dark.If by scheduling this meeting the investigation is over and they have a conclusion and our not going public yet ,well shame on them,if there is one thing we are disparate for is information as to what to do next,heres hoping every one,keep fighting

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

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

Artie commented below. I am posting Artie's comment back in a place where every one will see because I know the importance of arming yourself with research. I have worked for a major pharmaceutical company in my lifetime. I know that we need research and we need proof. Without that, we will be ignored.

Reply 1 minute ago on Apr 02, 2008 by artie81, #6536
Do you honestly think the people on this forum know how to interpret scholarly journal artcles?

Posted at 6:44 PM on Apr 02, 2008 by concernedcitizen, #29028
A British study suggests that Singulair should be studied for possible psychiatric adverse drugs reactions in children. I don't have this access to this journal so I have to try to find it. I will get back to you on what it says specifically. BMC Clin Pharmacol. 2008 Mar 17;8(1):1 Links Individual case safety reports in children in commonly used drug groups - signal detection.Brunlof G, Tukukino C, Wallerstedt SM. ABSTRACT: BACKGROUND: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children. METHODS: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<5 years old and experiencing psychiatric adverse drug reactions. CONCLUSION: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored. PMID: 18366638 The key sentence is: A POSSIBLE SIGNAL FOR MONTELUKAST (SINGULAIR) AND PSYCHIATRIC ADVERSE DRUG REACTIONS WAS FOUND, WHICH SHOULD BE FURTHER EXPLORED.

A British study suggests that Singulair should be studied for possible psychiatric adverse drugs reactions in children. I don't have this access to this journal so I have to try to find it. I will get back to you on what it says specifically.

BMC Clin Pharmacol. 2008 Mar 17;8(1):1 Links
Individual case safety reports in children in commonly used drug groups - signal detection.Brunlof G, Tukukino C, Wallerstedt SM.
ABSTRACT: BACKGROUND: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children. METHODS: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<5 years old and experiencing psychiatric adverse drug reactions. CONCLUSION: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

PMID: 18366638

The key sentence is:

A POSSIBLE SIGNAL FOR MONTELUKAST (SINGULAIR) AND PSYCHIATRIC ADVERSE DRUG REACTIONS WAS FOUND, WHICH SHOULD BE FURTHER EXPLORED.

I am Cody Millers mom ,the boy who died from Suicide while on Singulair for 17 days, I just wanted to say one thing to all of you that take the time to post.GO ONE STEP FURTHER CONTACT THE FDA and report to medwatch .The investigation needs evidence like your stories to help make informed decisions about this drug.The poorly orchestrated disclosing campaign that Merck had supposedly set out to accomplish in 2007, has obviously not reached the mass majority of people using this drug .Seeing now how many people did not make the connection to these HIDDEN AND DANGEROUS SIDE EFFECTS.Our child's pharmacy sheet that came with the medicine ,showed none of the updated side effects.They were added in April 2007,I filled the prescription in July 2007.Nothing had been disclosed until we put forth this effort to get the FDA's attention ,by asking the Senate and Congress to look into this matter.Go to your doctor and insist that they report YOUR SIDE EFFECTS to the company and the FDA.It is of the utmost importance.,Kate and Dave M.

Dear detersde, I think with all your experience in drug usage, you should know by now that any side effect experienced by the pax should be reported to the drug safety department, not when there's a fresh fire burning. For allergic/perrennial rhinitis I think you should try something safer like a budesonide spray like Rhinocort, it has no BAC, NO ALCOHOLS and worked wonders, and its barely 128 ug for a week until it completely stops. Safe to use even in pregnancies.

I'm a 35 yr male and have been dealing with depression/anxiety for years due to current & past issues in my life. This post IS dealing with singulair side effects but want to give some history as to why I think it's singular and not something else. For the past 2 or so years I've been using xanax which has worked fairly well in controlling my anxiety, but my doctor preferred I stop taking it because of it's potential for abuse. I've been on SSRI's before and I hated them, so I did some research and decided to try wellbutrin which works differently from the SSRI's. I was still using xanax while ramping up on wellbutrin the end of February. To my relief, the wellbutrin started working wonderfully - felt like I could cope with life, increased energy, better mood, with no negative side effects (actually some positive ones) - the only problem I was having is I traveled during this time frame and developed a bad case of sinus rhinitis due to the climate changes. I've had chronic sinus problems my whole life so it's no surprise. I tried most otc meds and nothing was helping. In the meantime I was feeling so much better (other than the rhinitis) that I decided to start tapering myself off the xanax. When I got to the point where I'd stop taking the minimal dosage I would start getting physical withdrawal symptoms (headaches, dizziness, etc) which is fairly common after taking for a prolonged period of time. The side effects were strictly physical - no excessive anxiety or psychological craving My sinuses were still really bothering me so I had two reasons to visit the doctor - try to get something to relieve my sinuses and to get a short supply of a benzo with a longer half-life to ease the withdrawal from xanax. The doctor gave me a prescription for a month of diazepam and 9 weeks of singulair samples. That was 3 weeks ago. I immediately begin using the singulair, but still had some xanax left so I decided to continue on a minimal dosage and use it up before I went to fill my rx, which I just started several days ago. Coinciding with when I started taking the singulair, all the positive benefits I was feeling from the wellbutrin just suddenly stopped. My depression and anxiety came back worse than they were before - another persons post describes the change in me: feel very anxious, fearful, reclusive, depressed, that everything is going to go wrong, or is always wrong. I'll have extreme anxiety about small everyday things. I’m unable to concentrate. I've also become more irritable, argumentative, and aggressive. I have difficulty falling and staying asleep. I also experienced a very noticeable decrease in sexual energy after a very noticeable increase which is a side effect of wellbutrin. I can even understand the rationale for suicide just to be free of this emotional nightmare - not that I would do it - but can understand it. I couldn't figure out why I went from finally feeling good about life to suddenly feeling worse than ever before. I guess I didn't realize it right away because my sinuses were much better, but I know these symptoms began occurring very shortly after I started to take the singulair. I was trying to figure out what was going wrong with me and yesterday I did a web search on 'singulair side effects' (since it’s the only variable I could think of that changed within that time period) and came across this site and several similar ones. It blew my mind how many people were talking about the exact things I was feeling. Yesterday was my last dose. Does anybody know how long it takes for this crap to work its way out of your system after 3 weeks of use???

Post your side effects at www.fda.gov/medwatch, on the Food and Drug Administration's (FDA) MedWatch site, which is under FDA's Center for Drug Evaluation and Research (CDER). According to someone from that office, CDER is supposed to report adverse events to their Drug Safety Oversight Board, and then the Board is supposed to decide if the drug should be pulled. FDA can claim they do not know about the claims if no one calls them. See staff below:

Steven Galson
Deputy Director
(301) 594-5400

Randy Levin
(301) 824-7784

Safety Policy and Communication Staff can be reached at (301) 594-0104. Staff include:

Paul Seligman
Norman Marks of MedWatch
Susan Cummins of Drug Safety Oversight Board

It's important that you report your side effects to MedWatch under the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). The phone number for CDER is (301) 594-0104. From a conversation with someone in CDER, they review the number of complaints they receive for a particular drug, and then the complaints are reviewed by the Drug Safety Oversight Board to determine if the drug should be pulled. If you do not report your side effects to FDA, they can claim they do not have enough complaints to warrant action.

On the FDA site go to "MedWatch" and report your side effects.

Below is a list of the persons in charge of CDER. All persons listed below can be reached through the number above.

The person overseeing the Safety Policy and Communications staff is:

Paul Seligman
(301) 594-5493 (FAX)

The person overseeing MedWatch is:

Norman Marks
(301) 594-6197 (FAX)

The person overseeing the Drug Safety Oversight Board is:

Susan Cummins
(301) 594-5493 (FAX)