FDA issues strongest warning on boxes of Singulair

The Food and Drug Administration announced this week boxes of montelukast will be required to have a prominent warning about the risk of neuropsychiatric events associated with the asthma and allergy medication montelukast.

Montelukast is sold under the brand name Singulair and in generic form. The box warning "advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis (hay fever)," the FDA said.

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The warning comes after the FDA reviewed continued reports of neuropsychatric events, including agitation, depression, sleeping problems, and suicidal thoughts and actions.

“(T)here are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription,” said Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA in 2008 issued a warning about the neuropsychiatric events associated with montelukast, but re-evaluated the data because reports of suicide continued. After the current review, the administration determined “the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies.”

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The FDA recommends patients stop using montelukast if they show the following signs:

If you're having an adverse reaction to Singulair, you can report it to the FDA via its MedWatch online volunary reporting site. You should also contact your doctor.