Singulair gets FDA’s strongest warning over depression, suicide risk

The Food and Drug Administration is issuing a boxed warning about montelukast, a widely prescribed asthma and allergy drug.


The Food and Drug Administration is issuing a boxed warning — its strongest warning — for a widely prescribed asthma and allergy drug, citing its potential to cause “serious behavior and mood-related changes,” the agency announced this week.

Montelukast, which is sold under the brand name Singulair and in generic form, may cause suicidal thoughts or actions, agitation, depression, sleeping problems and other mental health issues, the FDA said in a press release.

“Consistent with our prior evaluations, a wide variety of mental health side effects have been reported, including completed suicides,” the FDA said.

Most reported cases of psychiatric side effects occurred during montelukast treatment, the FDA said, but some occurred after stopping.

Why warning issued

The side effect rate is unknown, “but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” said Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research in a press release.

The FDA first approved montelukast in 1998. The agency updated the drug’s labeling in 2008 to include information about its psychiatric side effects.

“We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate,” the FDA said.

About the risks

The FDA said the risks of using the drug outweigh the benefits for some patients and that the drug should not be a first choice for allergy treatment.

For hay fever patients, the agency determined montelukast should be reserved for those who are not treated effectively with or cannot tolerate other allergy medications.

There are other safe alternative drugs to treat allergies, including products sold without a prescription, Seymour said


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