A Boxed Warning or “Black Box Warning,” the most prominent and serious of FDA warnings about prescription drugs, will adorn packages of asthma and allergy medicine montelukast (brand name: Singulair), the agency announced Wednesday.
The warning, a strengthening of what already comes with the drug, will address what the FDA calls “serious mental health side effects” and will recommend that montelukast be prescribed for hay fever sufferers only when there’s no other medical option.
Those side effects the FDA keeps hearing about include “agitation, depression, sleeping problems, and suicidal thoughts and actions.”
Such concerns aren’t new. A Netherlands study posted in 2017 on the Pharmacology Research and Perspectives website linked the drug to depression and nightmares in children. A 2018 Australian Broadcast Company report said the country’s version of the FDA, the Therapeutic Goods Administration, received “167 reports of psychiatric events in children and adolescents” from 2000 to 2017.
The TGA first put warnings on montelukast boxes in 2018. The FDA, which first approved the drug in 1998, has been looking into a connection to suicidal thoughts since 2008.
“Because of the risk of mental health side effects, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with other medicines,” the FDA said. “In addition, many health care professionals and patients/caregivers are not aware of the risk of mental health side effects despite the existing warnings in the prescribing information.”
Montelukast prevents asthma attacks and asthma ignited by exercise in people above the age of 6. Doctors can also prescribe it for long-term asthma treatment in adults and children more than 1 year old. Allergy prevention also makes the drug’s can-do list.
But, the FDA also says, “We continue to receive reports of mental health side effects reported with montelukast use. Consistent with our prior evaluations, a wide variety of mental health side effects have been reported, including completed suicides.
“Some occurred during montelukast treatment and resolved after stopping the medicine. Other reports indicated that mental health side effects developed or continued after stopping montelukast.”
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