Stronger warning required for Singulair due to reports of agitation, depression, suicidal thoughts associated with drug

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FILE – This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md. Health officials reported the first U.S. drug shortage tied to the viral outbreak that is disrupting production in China, but they declined to identify the manufacturer or the product. The Food and Drug Administration said late Thursday, Feb. 27, 2020, that the drug’s maker contacted health officials recently about the shortage, which it blamed on a manufacturing issue with the medicine’s key ingredient. (AP Photo/Jacquelyn Martin, File)

(WSPA) – The U.S. Food and Drug Administration announced last week that it is requiring a boxed warning for the drug, montelukast –sold under the brand name, Singulair — in an effort to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug.

According to the FDA’s news release, montelukast, or Singulair, is used to treat asthma and allergic rhinitis, or hay fever.

FDA officials said the boxed warning advises health care providers to “avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.”

In a new Drug Safety Communication issued on March 4, the warning follows the FDA’s review of data about continued reports of neuropsychiatric events 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,” Sally Seymour, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said. “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.”

According to the release, the FDA updated the product labeling in 2008 to include information about the neuropsychiatric events.

“In response to continued reports of suicide and other adverse events, the FDA evaluated available data regarding the risk of neuropsychiatric events, including reports submitted through the FDA Adverse Event Reporting System (FAERS) and observational studies in the published literature. The FDA also conducted an observational study using data in the Sentinel Distributed DatabaseExternal Link Disclaimer and presented the findings at an FDA advisory committee meeting in 2019,” according to the release.

FDA officials reportedly determined that the risks of montelukast may outweigh the benefits in some patients, especially in those cases where symptoms are mind and can be treated with alternative therapies.

Along with the stronger boxed warning, the FDA is also requiring that a new medication guide be given to patients with each montelukast prescription.

Patients who need to report side effects from montelukast can do so here.

Read the FDA’s full news release here.

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