PITTSBURGH (KDKA) — The Food and Drug Administration has strengthened existing warnings for a prescription medication for asthma and allergies.
The warnings are for Montelukast, known under the trade name of Singulair.
Montelukast/Singulair prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk.
The FDA decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.
Montelukast/Singulair is a prescription medication approved to prevent asthma attacks and for the long-term treatment of asthma in adults and children one year of age and older.
It is approved to prevent exercise-induced asthma in patients 6 years and older.
Montelukast/Singulair is also approved to control the symptoms of allergic rhinitis, also known as hay fever, such as sneezing, stuffy nose, runny nose, and itching of the nose.
It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older.
The FDA is urging patients to talk to their health care professionals about the benefits and risks of Montelukast/Singulair, as many other safe and effective allergy medicines are widely available.
They are also urging patients to talk to their health care professionals about any history of mental illness before starting treatment.