FDA says Singulair needs stronger label for depression risk, other side effects

Other side effects for the asthma and hay fever prescription include agitation, sleeping problems and suicidal thoughts

Some asthma and allergy medication will now require a stronger warning label, the U.S. Food and Drug Administration announced Wednesday.

The medication, generically known as montelukast, but sold under the brand name Singulair, now must have a prominent warning, called a “boxed warning,” about the risk of neuropsychiatric events, according to an FDA press release.

The neuropsychiatric events associated with montelukast include “agitation, depression, sleeping problems and suicidal thoughts and actions,” the release said.

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Singulair, sold by Merck, is typically used to treat asthma and hay fever, but now the warning will advise against prescribing the medication for patients with more mild symptoms, the release said.

On Wednesday, the FDA announced that montelukast, which is used to treat asthma and hay fever, must have a stronger warning label for side effects including depression and sleeping problems.

“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions,”DR Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research said in a statement. “The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks."

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“With today’s action, the FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions," Seymour added.

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After reviewing reports from the FDA Adverse Event Reporting System (FAERS) and conducting an observational study, the FDA “determined the risks of montelukast may outweigh the benefits in some patients,” the release said.

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Montelukast was first approved by the FDA in 1998 and will now require a new Medication Guide to go with a montelukast prescription.

The FDA requested that any side effects from montelukast should be reported to its MedWatch program, the release said.

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