Common Asthma Rx Gets Stronger Warning

FDA strengthens warning for neuropsychiatric events tied to Singulair (montelukast)

(RxWiki News) The US Food and Drug Administration (FDA) is requiring a stronger warning for a common asthma medication.

The FDA is now requiring a boxed warning for Singulair (montelukast). This is the strongest type of warning.

This warning is meant to strengthen an existing warning about possible neuropsychiatric events tied to this medication. These events include agitation, depression, sleeping problems, and suicidal thoughts and actions.

Montelukast, originally approved in 1998, is approved to treat asthma and allergic rhinitis (hay fever). The original warning regarding neuropsychiatric events was added in 2008.

The FDA decided that, for some patients, the risks of this medication may outweigh the benefits — especially when the symptoms are mild and can be treated with another drug.

Furthermore, for allergic rhinitis, the FDA has concluded that health care providers should reserve montelukast for those who do not see a response with or cannot tolerate other medications.

If you are currently taking this medication, speak with your health care provider. They can determine the best next step, which may include prescribing an alternative.

The FDA is also requiring a new Medication Guide for montelukast prescriptions.

Speak with your health care provider if you have any questions.