Prometheus 6

Merck officials stressed that the agency’s inquiry was based on reports, not clinical studies, which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials had committed suicide.

U.S. to Study Drug for Suicide Links
By THE ASSOCIATED PRESS

WASHINGTON (AP) — The Food and Drug Administration said Thursday that it was investigating a possible link between Merck’s best-selling drug Singulair and suicide.

The agency said it was reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who had taken Singulair, the popular allergy and asthma drug.

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