The Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast; known in Egypt as Singulair. The well-known medication is frequently prescribed for Asthma and allergy patients in Egypt; especially children.
After conducting an extensive review of available information and convening a panel of outside experts, the FDA determined that an additional boxed warning was needed. The warning will advice healthcare providers to avoid prescribing montelukast for patients with mild symptoms as allergic rhinitis, according to drug safety communication. Montelukast’s prescribing information already includes warnings about mental health side effects as suicidal thoughts or actions.
Why patients use Montelukast (Singulair and Montelukast Generics)
- Montelukast is prescribed for long-term treatment of asthma in adults and children 1 year and older.
- Prevents exercise-induced asthma in patients 6 years and older.
- Controls symptoms of allergic rhinitis, also known as hay fever, such as sneezing and stuffy nose.
- Treatment of seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older.
- Patients should talk to their physicians about the benefits and risks of Montelukast.
- Patients should report any history of mental health issues.
- Physicians should be clear with patients about the risk of neuropsychiatric events. Warnings about these side effects are included in the existing prescribing information; however, many health care professionals and patients are not aware of this risk.
- If changes in behavior or new neuropsychiatric symptoms, suicidal thoughts or behavior occur, patients are advised to stop taking the medication and talk to their doctors.
- Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program here.
Further reading: 6 Things Egyptian Asthmatic Kids Should Avoid This Season