FDA Investigates Suicide With Merck Drug Singulair

FDA Investigates Suicide With Merck Drug
By MATTHEW PERRONE | AP Business Writer
4:29 PM EDT, March 27, 2008

WASHINGTON - The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.

Merck has updated the drug's labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior.

FDA said it asked the Whitehouse, N.J.-based company to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it has not established a "causal relationship" between Merck's drug and suicidal behavior. An agency spokeswoman said the review was prompted by three to four suicide reports it received since last October.

It could take up to nine months before agency scientists can draw any conclusions, FDA said in a posting to its Web site.
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