March 6, 2020 at 2:59 pm

FDA Puts Black Box Suicidality Warning on Asthma Drug, Singulair

The FDA determined the “risks of treatment from Singulair outweigh the benefits in certain patients, particularly those with mild symptoms that can be adequately treated with alternative therapies.”

“As reports of suicide and other adverse events continued, the FDA evaluated available data on the risk for neuropsychiatric events, including from reports submitted through the FDA Adverse Event Reporting System and published observational studies. “

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