Singulair (montelukast) is a leukotriene receptor antagonist used for control of asthma and allergies. In March 2008, the FDA started a review to investigate numerous postmarket reports of suicidality related to the use of Singulair. Results of those reviews were recently published in the October 2009 issue of the Journal of Allergy & Clinical Immunology.
Each review went back through research data acquired during drug development to look for patterns that may have represented suicidality or "possible suicidality-related adverse events (PSRAEs)." These reviews were ordered by the FDA and completed by employees of the drug's manufacturer Merck.
There were no suicides reported during the clinical trials for Singulair. There was one case of suicidal ideation in almost 10,000 patients taking montelukast and none in over 11,000 control subjects (placebo and active control). The conclusion drawn was that PSRAEs were rare and similar to the control groups.
A related article in the same issue looked at behavioral-related adverse events (BRAEs) during Singulair clinical trials. The frequency of patients with 1 or more BRAEs was 2.73% and 2.27% in the montelukast and placebo groups, respectively. The frequency with a severe BRAE was 0.03% in both montelukast and placebo groups, suggesting no difference. And the frequency of patients being taken off of montelukast because of a BRAE was 0.07% while 0.11% of placebo patients were discontinued from the study for a BRAE.
Potential limitations of these reviews include the fact that they were completed by employees of Merck, and that they only included data collected during drug development, where suicidality would lead to exclusion from the study.
The latter issue is important because severe asthma and allergies have been associated with depression and anxiety and thus, such patients may be more prone to suicidality. Using Singulair in such patients requires proper counseling and close follow-up.
Anecdotally, I have seen patients (especially children) who do experience mood changes on Singulair. We stop the medication and provide other controllers of their symptoms, and there has never been complicating issues. For what it’s worth, I have also seen similar behavioral changes on antihistamines and even certain inhaled corticosteroids. And we commonly screen for depression/anxiety in our patients.
Practioners and patients should discuss the risks of behavioral changes with the use of Singulair before prescribing this medication.
As i read your blog,iam confused as to your stand on singulair,so i ask,when you did see mood and behaviour changes,did you take the time to report them to merck and the FDA ,did you encourage your patients to report also.The FDA did come out with a stronger warning in june of this year,after they completed their review.It is nice your office screens for this,but alas i fear you are the exception and not the rule.My own personel experiance with my son being on this drug was a four year nightmare,under the care and guidance of a major childrens hospital,when he suffered depression they sent us to a psychiatrist,when he suffered insomnia they sent us to sleep clinic,when he had a breakdown from anxiety they hospitalized,never ever was i told to stop the singulair,i figured that one out for myself.You can see many children fly under the radar,and we blame it on their condition rather than their meds.Now he is off of this poison,yes he is 99% better,but a part of him is forever changed.Children have died because of this med and will continue to fall victim until someone does the correct research,will that be you.
ReplyDeleteI am sorry to hear about your son's adverse reactions to Singulair, and his process does sound 'nightmarish.' My views on Singulair's use are generally positive, but everyone metabolizes medicines differently. One person's poison may be another's cure. I have seen too many patients (adults & children) benefit from Singulair to outright condemn it for its adverse events...Just as I would with many of the medications I have prescribed for my patients over my career. That might not be what you want to hear, but the use of any medicine involves risks and benefits. Part of the tough job of the physician is to decide when a condition can be managed without medicine vs prescribing a pharmaceutical that has the potential to cause more damage than good. First, you need to do no harm where possible, and strive to treat illness without medicine (ie prevention, trigger reduction, etc.). And you need to constantly listen to patients to look for possible adverse reactions if medications do become necessary. Again, I am sorry to hear about your son's ordeal. I hope he is better now.
ReplyDeleteMatt
Well thank you for your reply,i do understand that all meds come with risk,what i am fighting for is that the risks get disclosed.There are cracks in the system as it is that put at risk everyone.You said yourself that it was Merck itself that reviewed,and implied not to put to much stock in it,a huge crack in safety.The under reporting of adverse events.another crack.and the fact the CMI we recieve from the pharmacy with our prescriptions.not regulated by the FDA.These are cracks that children are falling through at an alarming rate,we must take steps as a people to close them.Yes my son is doing better thank you for asking,he takes no meds now and is thriving,but i cannot forget or forgive the 3 years i was desparate to save his life,and found no help in the medical system.It is imperitave that we know all about the drugs we put in our and our loved ones system we need to demand full disclosure,both the good and the bad.
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