FDA investigates link between Merck asthma pill and suicide
Posted by Administrator (admin) on Mar 31 2008 at 5:28 PM
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WASHINGTON - The Food and Drug Administration (FDA) is investigating a potential connection between Merck's best-selling Singulair and suicide.

FDA is assessing the reports indicating mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.

Millions of patients are currently using the drug, which was first approved in 1998.

FDA has asked New Jersey based Whitehouse to dig deeper into its info on Singulair for proof of possible links to suicide. According to FDA, they haven’t identified a “casual relationship” between Singulair and suicidal tendency. The review was incited by four suicide reports it received months back.

FDA said it may take up to 9 months for their scientists can reach any conclusions.

FDA has started notifying the public about potential safety issues.

"Patients should not stop taking Singulair before consulting with their doctor," FDA said in its statement. They added that doctors should monitor patients for suicidal behavior and changes in mood.

Merck officials said that the FDA’s inquiry is not based on clinical studies.

“Clinical studies are the standard tool to evaluate drug safety. None of the 11,000 patients enrolled in 40 Singulair trials has committed suicide,” said George Phillip, director of research and product development.

However, Merck has recently added reports of suicide to Singulair's label. They had already listed suicidal tendency as reported side effects.

“Though we have no such indication, we thought it was important to provide this information in the product label because suicide is a life-threatening event,” Philip said.

According to clinical trials of asthma patients, the most common side effects were abdominal pain, headache, flu, and cough.