FDA Orders Psychiatric Warn Labels On Asthma Drugs

Law360, New York (June 12, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has asked AstraZeneca Pharmaceuticals LP, Merck & Co. Inc. and Cornerstone Therapeutics Inc. to update the labeling for their leukotriene modifiers class of asthma drugs to include a precaution warning against psychiatric side effects.

The FDA requested that the drugmakers update their labeling on Friday after concluding an investigation of reported neuropsychiatric events arising from the use of the drugs.

The drugs named in the FDA’s report are AstraZeneca’s Accolate, Merck’s Singulair and Cornerstone’s Zyflo and Zyflo CR.

The agency...
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