FDA Investigating Possible Increased Risk Of Suicide From Popular Asthma Drug Singulair

ABCNews says that the FDA announced Wednesday that they are investigating a possible connection between suicide and the popular asthma drug Singulair.

Concerns over “behavioral issues” with Singulair developed over the past year. Merck periodically updated the drug’s labels to include warnings for tremors, depression and anxiety. FDA spokesperson Susan Cruzan said reports of suicides by “three or four” people who were taking Singulair prompted Merck to clarify suicide warnings on labels and patient information sheets in October 2007.

“When the company does that and we think there’s a reason to look at it, we’ll go back and analyze the data,” said Cruzan, who stressed that the FDA cannot prove a link between the Singulair and the reported suicides. “We are going back to review all of the data to determine whether there is a cause-and-effect relationship.”

Neither the FDA nor Merck, the manufacturer of the drug, recommended that patients discontinue use of the medicine.

The current warning label on Singulair reads:

“The following additional adverse reactions have been reported in post-marketing use: Psychiatric disorders: agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), tremor.”

Doctors Not Concerned by US FDA Probing Safety of Merck’s Singulair [ABCNews]