The U.S. Food and Drug Administration (FDA) has announced that montelukast, commonly known by its brand name Singulair, will now carry a “Black Box Warning”—the agency’s most severe warning. This decision comes as research indicates that the medication, used to treat asthma and allergies, is associated with serious mental health side effects, including suicidal thoughts and depression. As a result, the FDA advises that montelukast should only be prescribed when other treatment options are not viable.
The FDA’s warning highlights a range of potential adverse mental health effects linked to the medication, such as agitation, insomnia, depression, and even suicidal behavior. Concerns first emerged following a 2017 study conducted in the Netherlands, which found a connection between montelukast and increased instances of depression and nightmares in children. Additionally, an Australian report from the Therapeutic Goods Administration revealed that between 2000 and 2017, there were 167 reports of psychiatric events in young patients.
The FDA cautions that the risks associated with montelukast may outweigh its benefits, particularly for patients experiencing mild symptoms that can be effectively managed with alternative treatments. Many healthcare providers and caregivers may not be fully aware of these risks, despite existing warnings in the prescribing information.
Reports indicate serious mental health issues, including completed suicides, some of which occurred during treatment with montelukast and subsided after discontinuation of the drug. In 2018, around 9.3 million prescriptions for montelukast were filled in the U.S., with about 2.3 million of those for children under 17.
If your child is currently taking Singulair, it’s crucial to consult with their healthcare provider immediately if you notice any changes in mood or behavior. Symptoms to watch for include:
- Increased agitation or aggression
- Attention difficulties
- Disturbing dreams
- Symptoms of depression or anxiety
- Confusion or disorientation
- Hallucinations
- Irritability
- Memory issues
- Restlessness and sleepwalking
- Tremors or shakiness
- Suicidal thoughts or actions
Dr. Alex Rivers, an expert from the National Association of Allergy and Asthma, advises parents to maintain a level head. “All medications carry potential side effects. It’s essential to consider whether your child is using montelukast for asthma or allergic rhinitis, as there are many effective alternatives available,” he noted. He also emphasized that children should not miss out on activities due to uncontrolled asthma symptoms, and visiting an allergist may be beneficial.
The FDA has re-evaluated the overall risk versus benefit of montelukast, particularly given the availability of safer allergy medications with proven track records. The agency strongly suggests that montelukast should not be the first-line treatment for mild allergic rhinitis symptoms.
Healthcare professionals are encouraged to report any side effects associated with montelukast through the FDA’s MedWatch program. For more information on pregnancy and home insemination, check out this excellent resource at Rmany’s blog.
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In summary, the FDA has issued a serious warning about montelukast, urging caution for parents of children who take this medication due to its potential link to mental health issues. Always consult with a healthcare professional before making any decisions about your child’s treatment plan.
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