The U.S. Food and Drug Administration (FDA) has announced that it strengthens existing warnings to montelukast (Singulair) about potential risks associated with mental health, such as serious behavior and mood-related changes.
Montelukast is often prescribed to treat allergy and asthma.
The agency said it would add a “boxed warning” to montelukast recommending medical providers to avoid prescribing the drug to patients with mild symptoms of allergy, especially allergic rhinitis.
In 2008, the FDA updated the product labeling that includes information about neuropsychiatric events associated with the use of montelukast.
The FDA has been reevaluating the benefits and risks of montelukast since its approval in 1998.
The agency reviewed all data in response to continued reports of mental health issues, including suicide, and other side effects. It will conduct an observational study for more details.
Keeping the findings in the mind, the U.S. drug regulatory body determined that the risks of montelukast might outweigh the benefits in some patients, especially when the symptoms are mild and can be effectively treated with other therapies.
Dr. Sally Seymour, Director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said, “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,’ she added.
Dr. Seymour explained that the FDA aims to ensure medical providers and patients have the information available, especially doctors so they can make informed treatment decisions.
She said, “Importantly, there are many other safe and effective medications to treat allergies with an extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition, the FDA said it would require doctors to give a new medication guide to patients with each montelukast prescription. Doctors are also encouraged to report any adverse effects of montelukast.
