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Litigation Update: Singulair Required to Add Black Box Warning

Litigation Update: Singulair Required to Add Black Box Warning

The FDA announced on Wednesday, March 4th, that Montelukast, an allergy medication sold under the brand name Singulair, will be required to include a boxed warning. The label was last updated in 2008 after a number of events involving suicide or serious psychiatric issues, required the manufacturer to disclose risks associated with the medication including agitation, depression, sleeping problems, and suicidal thoughts and actions.

Since that last warning update, the agency had been gathering data to link usage and mental health issues through the FDA Adverse Event Reporting System and other sources.  Based on this information, it was determined last week that the risks of the medication might outweigh its benefits for some patients. By upgrading the warning label, the FDA wants to alert doctors of the dangerous risks and ensure that they do not prescribe the medication to patients with mild cases of allergies or hay fever that could be treated with other treatments instead. Additionally, patients who are prescribed Singulair, will receive a medication guide describing the potential risks and warning signs.

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