FDA probes ties between Singulair, suicide.
WASHINGTON - The Food and Drug Administration said yesterday that it was investigating a possible link between Singulair, Merck & Co. Inc.”s popular allergy and asthma drug, and suicide. The FDA said it was reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who had taken Singulair. Merck has updated the drug”s labeling four times in the last year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior. The FDA said it had asked Merck, of Whitehouse Station, N.J., to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it had not established a ‘causal relationship’ between Merck”s drug and suicidal behavior. An FDA spokeswoman said the review was prompted by three to four suicide reports the agency had received since October.
For Immediate Release
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