Parenting Big Kids (5-8) Support Group

Although I’m sure most parents are now well aware of the recent attention Singulair has received, I thought it might be good to summarize what the FDA released just a couple of days ago. A bit of background worth mentioning first is singulair is a leukotriene receptor antagonist and is used to treat asthma and symptoms of allergic rhinitis. Over the past year, Merck & Co, Inc. (which is the maker of Singulair) has updated its prescribing and patient information to include tremor, depression, suicidailty, and anxiousness among the medication’s adverse events. And just last month, the FDA and Merck discussed how best to communicate these recent changes to both the prescribers and patients of Singulair (and I might add here it would be worthwhile to take a look at the Singulair website…singulair.com" title="http://www.singulair.com" target="_blank"> www.singulair.com … for further details).

So what the FDA just recently announced is that it is investigating this possible association between the use of Singulair and behavior/mood changes and suicidal thinking and behavior. And specifically, while the FDA will perform its own review, it has also requested that Merck evaluate Singulair study data for more information surrounding suicidality and suicide. It is believed these evaluations may take up to 9 months, but when complete, the FDA will release its findings and give recommendations to the public.

At the present time, there is no formal recommendation to stop taking Singulair, but certainly discussion with your child’s physician is worthwhile and as more information is made available, you’ll be sure to find it here at DS.

Dr. Jeremy
Posted on 03/30/08, 12:03 am