Saturday, July 4, 2009

FDA's new warning on Singulair

On 6/12/09, the FDA issued a new warning on leukotriene inhibitors, which includes Singulair, Accolate, and Zyflo. Singulair is the only one of the three to be approved for allergic rhinitis and also exercise-induced asthma. The FDA is concerned about "reported neuropsychiatric events that include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor." Since this issue was raised over one year ago, I have seen two cases that were associated with Singulair, but not proven to be caused by Singulair. They could have occurred by random chance, to be fair. Nevertheless, I agree with the FDA that if they have significant information that could help patients avoid injury and suffering, then a warning must be issued. I shall be very interested in what data is actually released and if it supports the need for a warning.

1 comment:

Heidi said...

This is a high concern of mine. I have noticed some changes in my children that seem to be of these side effects. They have been on singulair for a couple of years. Since moving to Tn their nose runs constant and they keep getting sick. They have been taking this which slows it down not stops it. But I am not willing to take the chance if this is causing the changes I've seen. Does someone know what I can replace this with?

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