FDA investigating asthma drug Singulair and possible suicide link

The U.S. Food and Drug Administration is reviewing Merck’s top-selling allergy and asthma drug after receiving a handful of reports that patients taking the drug have mood changes, suicidal behavior and actual suicide.

Singulair, Merck’s best selling drug ($4.3 billion last year), is used to treat allergies and asthma. But Merck has been receiving various reports about Singulair's new side effects. As a result, it has updated the drug label four times in the past year to include additional information about the side effects. The side effect information now reads the following: tremors, anxiousness, depression and suicidal behavior along with the original side effects, headache, flu, abdominal pain and cough. The U.S. FDA is reviewing the reports also and want Merck to analyze their data further to see any evidence or possible links to suicide. The agency’s own investigation has not found any connections so far, and the FDA says it will take up to nine months to study and draw conclusions. The FDA usually only makes announcements like this after full investigations, it the organization was criticized recently for being slow to look at the risks of Merck's painkiller Vioxx and GlaxoSmithKline plc’s diabetes pills, so it has take the stop of announcing the investigation as a way to warn patients and doctors. Merck officials stressed the FDA's inquiry is 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 has committed suicide. George Philip, director of research and product development told Reuters:

"We have no indication that anything about the mechanism of Singulair is consistent with these events…But because suicide is a life-threatening event we thought it was important to provide this information in the product label."

Philip, of course, will defend his company’s drug but I hope the FDA relies on its own analysis rather than Merck’s to come to a conclusion. In a statement, the FDA said patients shouldn’t stop taking Singulair until they talk to their doctor and advised doctors to monitor patients for suicidal behavior and mood changes. So in addition to regular medical duties, doctors now need to do the job of a psychiatrist. Instead, they should be looking for a drug that does not have suicide as a side effect.