FDA Continues to Review Neuropsychiatric Effects of Singulair
Posted by Administrator (admin) on Jan 15 2009 at 2:28 PM
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January 14, 2009 – The US Food and Drug Administration (FDA) said that they are continuing to review clinical trial data regarding adverse and neuropsychiatric actions linked to Singulair and similar asthma drugs.

Singulair, manufactured by Merck & Co., is one of a class of drugs called leukotriene receptor antagonists. It has been approved to treat asthma. Accolate, Zyflo and Zyflo CR are some other leukotriene modifying medications. Accolate is a leukotriene receptor antagonist, where as, Zyflo and Zyflo CR are leukotriene synthesis inhibitors.

The FDA is yet to reach an authoritative conclusion regarding the clinical trial data on mood and behavioral adverse events associated with Singulair.

According to the FDA, Merck has submitted results from 41 placebo-controlled clinical trials.  In this, 9,929 patients were treated with Singulair while 7,780 were treated with a placebo. One adult out of 9,929 patients treated with Singulair had experienced suicidal thoughts. Anyway, there were no completed suicides.

According to the data submitted by the company, the product is not associated with suicide or suicidal behavior, the FDA said. But, the FDA has noted that the trials were not intended to decide suicidal behavior. Therefore, the agency says, it is continuing to review the clinical trial data in order to evaluate other neuropsychiatric events such as mood and behavioral adverse events associated with the medication.

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