Singulair May Be Linked To Increased Risk Of Suicide
By MedHeadlines • Mar 28th, 2008 • Category: Asthma, Drugs, Family, LifestyleThe US Food and Drug Administration (FDA) has announced that the agency is evaluating available data for a potential link between some serious issues involving mood changes and behavior affecting patients who take Singulair (montelukast) manufactured by Merck & Co, Inc.
According to some reports, Singulair prescribed in the treatment of asthma, allergic rhinitis and prevention of exercise-induced asthma, has been associated with unpleasant mood changes, suicidal thinking and behavior (suicidality), and suicide itself. Merck & Co, Inc has made several changes to the patient and prescriber information issued for Singulair and has worked with the FDA to determine how to communicate the latest changes in the most effective manner.
Recent information updates have included alerts for adverse reactions that now include tremor, depression, suicidality, and anxiousness. Plans to increase awareness of these potential side effects include personal interaction with prescribers and information leaflets for patients. Merck is conducting a re-evaluation study for Singulair and the FDA is reviewing patient reports of adverse reactions while taking Singulair. The FDA anticipates the review and evaluation process may take as long as nine months before firm data is available for public release.
This early communication about the safety review of Singulair does not mean that the FDA is asking healthcare professionals to discontinue prescribing the medication. Individuals currently taking Singulair are urged to continue to do so, but patients and physicians alike are also urged to be aware of the potential for these side effects and to take appropriate action if any should develop.
Singulair is a leukotriene receptor antagonist with mechanism of action similar to Accolate (zafirlukast). Another popular drug used for the treatment of similar symptoms is Zyflo/Zyflo CR (zafirlukast), which is a leukotriene synthesis inhibitor. The FDA is also reviewing reports of similar adverse reactions reported in patients taking these medications to determine if further investigation should be made.
Patients and physicians are requested to report any incidence of these adverse reactions while taking any of these drugs. The FDA has a program for reporting adverse reactions, the MedWatch Adverse Event Reporting program, that can be accessed by:
going online to www.fda.gov/medwatch/report.htm,
by calling 1-800-332-1088, or
by faxing to 1-800-FDA-1078.
This announcement was issued in compliance with the FDA’s early communication program for sharing information with the public concerning the investigation of safety issues for drugs prescribed in the US.
Source: FDA
My doctor prescribed Singulair for me last November saying that I could try it to see if it would help my chronic sinus problems. He told me that the medication seems to help some people but, on others, it seems to have little or no effect, so it would be a hit or miss kind of proposition. I have a high deductible medical insurance policy because it is the only policy my employers, who own a small business, can afford so my prescriptions are not covered until I pay $2,500 out of my own pocket every year. Consequently, when I went to pick up my first 30 days worth of Singulair and found that it was going to cost me $90.00, I declined to take the prescription. If I had to pay $90.00 every month for a single medication, I might consider suicide.
This drug did nothing to improve my breathing or allergies. And it is very expensive. Physicians are being bombarded with bribes from these pharmacutical companies to prescribe the most expensive drugs out there and as a result they are dispensed as a first choice. Patients need to be proactive and do a little research before blindly accepting the doctors advice. It is after all a business.
I took my 19 month old daughter to the doctor last Friday sinus/breathing difficulty. He prescribed her Singulair as a maintenance drug. My wife & I noticed that my daughter’s personality was like night and day when she was taking it. After I heard this news on NPR while driving home yesterday I told my wife about the FDA study and the effects so we took my daughter off of Singulair. Maybe MERCK should quit the pharmaceutical business altogether, first it was Vioxx, now it’s Singulair.
To GERN: Physicians are not BRIBED to prescribe any meds. Please get your facts straight before saying things that you know nothing about. I have yet to ever be bribed to write any drug!!!
For some folks, singular works well. I was put on it for asthma, and while that is a long-term process, it had the wonderful side effect of decreasing my allergy attacks considerably (a use it was approved for later, but seems to be the main advertising push now). When I switched insurers I had to go off it for a couple weeks while everything was straightened out, and I really noticed the difference, both for increased asthma attacks for a while and increased allergy issues. The warnings are good to know–but the drug still can be very useful.
While Doctors DO NOT get bribed by prescribing a particular medication the truth is that they do get plenty of other incentives, please consumers are not stupid, we all know this FACT. Moving onto another FACT I would venture to say that far too many of our Doctors in United States have let us down by their lack of partnership with patients, their apathetic behavior, and real and seld created pressures, result in a cadre of professionals that consistently provide substandard and poor quality of care. Just look at healthcare outcome and malpractice statistics. The singular story is NO surprise. I was first put on this drug and 6 months after seeing NO improvement whatsoever and feeling out of my self moody yes I self unmedicated and stopped! My Dr.’s response…you are on your own Jose, I can’t help you anymore! Well, I’m thrilled to have stopped this medication. As for my doctor … I quit him too…but I’m not sure if my new one is any better…
To Wendy: So what are the facts? Do pharmaceutical companies offer any incentives to the medical community for learning/promoting/prescribing their products? I would predict that public opinion is that non-scientific factors play a bigger role than they deserve, maybe we are wrong, but it is clear that a large amount of money is spent in promoting new drugs — across many channels — including incentives to physicians to learn/promote the products. Perhaps more of that money should be spent on making treatments safer and more effective and in making the overall system more efficient.
I think it would be helpful for us shine a bright light on the social and economic forces that lead to promotion and prescription of new medical treatments and ensure that ensure that science is still the foundation.
The good news is that news articles like this (and the tragedies behind them) will push our society in that direction anyway. We normally need to learn things the hard way.
My son is 10yrs. old and has been taken Singular for going on five years now. One thing I have noticed about my son more recently is a change in his moods. One minute he laughing, cracking jokes, the next he so angry that he’s breathing is more difficult, amoung other things. The other thing are the dreams he has. I call them nightnares, because he is kicking, running screaming and fighting in his sleep. And this is on a regular. I would say at least three times a week. I know this because he usually ends up in my bed. I get kicked, elbowed and hit. I didn’t understand what was happening, I guess this new information explains what my child has been experiencing.
I have never heard of this drug as I am not aware of many drugs but it sounds very exspensive. I will never take this for my asthma but thats just my point of view
I have been taking Singular for 9 years and personally for me, it has been great. There have been a few occasions when I have run out of the medicine and gone without it for a few days. I really regret it when I do that because I will start having breathing problems, asthma attacks or allergy problems. For me the drug works. We all have to be wise and take charge of our bodies. Not all drugs are for everyone. So it is your responsibility to tell your doctor if the medicine he prescribed for you is not working or you don’t like the side effects. Don’t put all the blame on your doctor if you are not going to give him/her any feedback about it. As for me and others the medicine has been great, a lot better than having to use inhalers all the time.
As for the doctors, you can not put all doctors in the same box or stereotype them all like that. I know some wise, honest, godly doctors who are not swayed by any gifts they might receive from phama. companies. They only prescribe what they believe is right for that patient and often encourage you to buy the generic drug if there is one available.
My daughter was on Singular about 4 years ago. She’s 8 now. She took it for a short time as I noticed she was having night terrors. Full blown-running wildly, hallucinating of bugs and snakes, screaming hysterically, crying, wide eyed. Nothing would console her. I made the connection that she never had them until she took the Singular. I asked 2 different physician’s who said they had never heard of that, but the 2nd agreed that I should take her off of it, see if they subsided, try the singular again and see if the night terrors returned. I was right. When off the singular she stopped the night terrors. Immediatly after taking it again they returned. She has never taken Singular again.
I used to have significant exercise induced asthma. Aftert 6-8 weeks taking Singulair, the symptoms disappeared! I no longer need to use a rescue inhaler. I have not noticed any of the side effects mentioned. There probably are many variables which may or may not result in specific side effects. People should be aware of all potential side effects, but they should also consider the positive affect of the medication and the probability that they may not experience particular side effects. It worked well for me and I assume many others. Perhaps it needs to be Rx with a warning.
i work in pharmaceutical advertising (directed toward physicians) and i can tell you that it is flat-out illegal to try to bribe a physician into using your product. merck in particular has very strict guidelines about what you can legally say to a physician, and what you can “offer” him or her. we are only allowed to provide marketing materials that provide educational value to the physician and his or her patient. yes, many physicians are paid to speak on/endorse a particular drug, but they have to have some clinical experience with the product–namely, they need to be involved in some type of clinical trial.
also, you must give full disclosure about your drug’s clinical efficacy, side effects, and potential drug interactions. it is a very rigourous process that is subject to legal review after legal review.
yes, pharmaceutical companies have a profit motive, and i am not naive enough to believe that no abuses ever take place, but i know that my work is scrutinized by both merck’s legal and medical departments, as well as by the FDA, on a regular basis.
as for singulair itself, i both take and market the drug, and so far i have had no side effect issues at all. in fact, it greatly improved both my asthma and allergy symptoms, and for that i am grateful. of course, if i started having any kind of ideation problem, i would contact my doctor and seek out another alternative.
i think that many consumers are very jaded and quick to go on a corporate witchhunt without understanding the totality of a situation. to date, i think merck has been fairly responsible in how it has responded to both the vioxx and singulair issues. i am not saying singulair is not without any potential side effects, but i think the company has taken a proactive stance to investigate the issue further.
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I’m with Renee. My ENT doc suggested this to help control my allergies since Zyrtec alone wasn’t doing a great job. I’ve been on it for years with no adverse effects. At the time I started it I wa told that it didn’t work for everyone (less than 50%), but if it did work, it was very helpful. I guess I’m in that minority group. I should say that I’m an adult, and dealing with kids is something entirely different.
My oldest son took singulair through his adolescent years and suffered from nightmares, mood swings and cutting. I wonder if it was caused by the singular. I had never even considered that as a cause. He no longer takes it (19 years old) and does not exhibit these symptoms anymore. I wonder if there is a connection. I hope they further study it before more people have to suffer.