The FDA issued an early communication advising that it is investigating a possible risk of suicidality with Merck’s allergy and asthma drug Singulair.
“FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA,” said the agency, estimating that it will take up to 9 months to complete its evaluation of the issue. The agency said it has advised Merck to reevaluate Singulair study data and is reviewing the relevant postmarketing reports.
Over the past year, Merck has updated prescribing information and patient information for the drug to advise of post-marketing adverse events including tremor, depression, suicidality and anxiousness.
FDA is also looking into similar postmarketing reports for other leukotriene modifying medications, including AstraZeneca’s Accolate and Zyflo/Zyflo CR, from Dey and Critical Therapeutics.
For a January 2024 article on renewed concerns over asthma drug Singulair’s psychiatric risks, click here.
