The widely prescribed asthma medication Singulair, also known generically as montelukast, has come under renewed scrutiny following research suggesting potential links to severe mental health side effects, including suicide.
Emerging Concerns Over Brain Receptor Activity
New findings presented by the Food and Drug Administration (FDA) at the American College of Toxicology meeting on November 20 revealed that Singulair exhibits “significant binding” to multiple brain receptors, according to Jessica Oliphant, deputy director at the FDA’s National Center for Toxicological Research. These receptors play roles in mood regulation, impulse control, cognition, and sleep.
However, while the study identified this binding activity, it has yet to establish a direct connection between the drug and the reported mental health side effects. Laboratory studies on rats have shown that the medication can penetrate the brain, but further research is needed to determine how it interacts with the nervous system in humans.
Despite these findings, the FDA has not announced updates to the drug’s labeling based on the recent data.
A History of Concerns
Singulair, initially introduced by Merck & Co. in 1998, is prescribed to manage asthma and allergy symptoms by reducing airway inflammation. Available under various generic names such as montelukast sodium, the drug has been marketed as safe and effective, with early advertisements comparing its side effects to those of a sugar pill.
However, reports of neuropsychiatric episodes and mental health issues in patients taking the medication have surfaced over the years. By 2019, thousands of individuals reported experiencing severe side effects, and dozens of suicides were linked to the drug.
In 2020, the FDA mandated a Boxed Warning—the agency’s most prominent safety alert—highlighting the risks of suicidal thoughts and other psychiatric side effects. It also recommended restricting the drug’s use for treating hay fever.
Documented Side Effects
Singulair has been associated with a range of mental health side effects, as reported by the Cleveland Clinic, including:
- Anxiety
- Confusion
- Hallucinations
- Irritability
- Depression
- Hostility
- Suicidal thoughts or self-harm
- Nightmares and vivid dreams
Patients experiencing these symptoms are urged to contact their healthcare providers immediately.
FDA Evaluating Regulatory Actions
In October 2024, the FDA flagged Singulair for serious risks and potential new safety measures. The agency is currently assessing whether additional regulatory actions are necessary to address the growing concerns about the drug’s safety.
Expert Opinions on the Risks
Researchers involved in studying the drug, including Austrian scientist Julia Marschallinger, emphasized the significance of these findings. “The medication is definitely doing something that’s concerning,” Marschallinger told Reuters.
Marschallinger, along with colleague Ludwig Aigner, contributed to earlier research that informed the FDA’s decision to strengthen warnings about Singulair’s mental health risks.
A Call for Awareness
The ongoing investigation into Singulair underscores the importance of vigilance in both prescribing and using medications. Patients and healthcare professionals are encouraged to report adverse effects promptly to facilitate further research and ensure safety.
If you or someone you know is experiencing suicidal thoughts, support is available through the U.S. National Suicide Prevention Lifeline at 988 or via online chat, 24/7.
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