(RxWiki News) The US Food and Drug Administration (FDA) has approved the strongest possible warning for a common asthma medication.
In March of this year, the FDA reported the requirement of a boxed warning for Singulair (montelukast). A boxed warning is the strongest type of warning.
Now, the warning is approved and official.
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.
This label change and approval are steps to increase awareness of potential mental health side effects tied to Singulair, according to the FDA.
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.
For asthma, the FDA recommended that health care professionals consider the risks compared to the benefits before prescribing montelukast. The FDA is also requiring a new Medication Guide for montelukast prescriptions.
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. Speak with your health care provider if you have any other questions.