The Food and Drug Administration has announced that they are going to look into a possible link between Merck's best-selling Singulair and suicide. The agency is reviewing a handful of reports of mood changes, behavioral changes, suicidal behavior, and suicide in people who had taken Singulair.
Singulair is an asthma and allergy medication. Merck has revisted the drug's label four times in the past year. They have added information each time concerning reported side effects. The new side effects on the label include tremors, anxiousness, depression, and suicidal behavior.
The FDA has currently asked Merck to look into its data concerning Singulair for evidence of possible links to suicide. The FDA says it has not established a causal relatonship between suicide and Singulair. The reivew of the drug was prompted by a few suicide reports that have been received since last October. The investigation could take up to 9 months to complete. Merck is currently emphasizing that the suicide reports were based on use, not statistical evidence.
Singulair was first approved in 1998 and had sales of $4.3 billion in 2007.