FDA requires boxed warning on Singulair

Due to reports of depression, suicidal thoughts and actions, and other side effects, FDA is requiring a new boxed warning on generic and brand-name montelukast (Singulair, Merck & Co.).

The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis. Singulair is used to treat asthma and allergic rhinitis (hay fever). FDA is also requiring a new Medication Guide to be given to patients with each montelukast prescription.

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FDA shares in its Drug Safety Communication that it made the decision after reviewing data regarding “continued reports of neuropsychiatric events with montelukast, such as agitation, depression, sleeping problems, and suicidal thoughts and actions.” 

“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. 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,” says Sally Seymour, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

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

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Other medicines to treat hay fever include antihistamines such as loratadine (Alavert, Claritin), fexofenadine (Allegra), cetirizine (Zyrtec), levocetirizine (Xyzal), and diphenhydramine (Benadryl), along with steroid nasal sprays such as fluticasone (Flonase), triamcinolone (Nasacort), and budesonide (Rhinocort).

“Alternatively, allergy shots have been shown to decrease symptoms of allergic rhinitis,” according to the FDA.

The FDA updated Singulair and generic Singulair’s labeling in 2008 to include information about neuropsychiatric events reported with use of montelukast.

However, in its new review, FDA re-evaluated the benefits and risks of montelukast as the treatment landscape has evolved since the drug was first approved in 1998.

“Based upon this assessment, the FDA 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. For allergic rhinitis in particular, the FDA has determined that montelukast should be reserved for patients who have not responded adequately to other therapies - or who cannot tolerate these therapies,” the agency says.

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