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WASHINGTON — New labels on popular asthma drugs such as Merck’s Singulair must highlight language about suicidal behavior, depression and anxiety seen in a small number of patients, federal regulators said Friday.
After 15 months of investigation, the Food and Drug Administration said Merck & Co. Inc., AstraZeneca and Cornerstone Therapeutics will have to raise label warnings about psychiatric problems reported by a handful of patients.
The FDA said the language of the labeling updates could mention a slew of psychiatric problems, including: “agitation, aggression, anxiousness, dreams and hallucinations, depression, abnormalities, insomnia, irritability, restlessness, suicidal thinking and behavior — including suicide — and tremors.”
