FDA Requires Boxed Warning for Singulair, Generics
The US Food and Drug Administration (FDA) on Wednesday said it is requiring a boxed warning and medication guide for Merck’s asthma and allergy drug Singulair (montelukast) and its generics to strengthen existing warnings about the risk of neuropsychiatric events, including suicides, linked to the drug.The agency also says that montelukast should not be used in patients with mild symptoms and should only be used to treat allergic rhinitis in patients have not responded to or who cannot take other treatments.
“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,” said Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products at the Center for Drug Evaluation and Research.
FDA notes that there are other widely available drugs indicated to treat both asthma and allergic rhinitis, including antihistamines such as Allegra (fexofenadine), Benadryl (diphenhydramine), Claritin (loratadine), Xyzal (levocetirizine) and Zyrtec (cetirizine) and steroid nasal sprays such as Flonase (fluticasone), Nasacort (triamcinolone) and Rhinocort (budesonide).
FDA first approved Singulair in 1998. A decade later, in 2008, the agency updated Singulair’s labeling to reflect reports of neuropsychiatric events in patients taking the drug. In 2012, the agency approved the first generic versions of the drug.
Despite the updated labeling, FDA says it continued to receive reports of suicide and other mental health side effects related to montelukast, prompting the agency to conduct a new review into the its safety.
FDA, Drug Safety Communication