US health regulators are probing a possible connection between Merck & Co's Singulair asthma drug and suicidal behavior, the US Food and Drug Administration said today.
The FDA said it is reviewing the issue after receiving reports of mood and behaviour changes, suicidal thinking and suicide in patients who took the drug, which is used to treat stuffy nose, sneezing and other allergy symptoms as well as asthma. The agency did not say how many reports it had received.
While no definite link to the drug has been established, the FDA said it has asked Merck to evaluate its data for more information on the risk. The agency said it expects it to take up to nine months to finish its own review.
The FDA said it is also reviewing reports of behavioral changes in patients taking other similar drugs, including AstraZeneca's Accolate and Critical Therapeutics' Zyflo but has not yet decided whether further investigation is needed.
Merck earlier added information about the risk of tremors, depression, anxiousness and suicidal behavior to Singulair's label.
