Black Box Warnings & Suicide
Dominic had a history of mental health challenges before he visited the doctor for his asthma. He was not warned of any potential mental health consequences before he was prescribed montelukast. Within three months, he was experiencing suicidal thoughts and struggling with self-harm.
The FDA requires that medications have a prominently displayed warning on the label when there is a potential for serious negative reactions, particularly death or injury. These are called black box warnings. A black box warning is the highest level of warning a medication can have. It is not just a side effect disclaimer.
Given the fact that suicide is the leading cause of death in jails, it is important for jails and providers collaborating with jails to be aware of medications that have black box warnings for suicide risk. For example, montelukast (brand name Singulair) recently received a black box warning – 25 years after its release.¹
The drug is currently prescribed to 31 million Americans to treat allergies and asthma.² montelukast “now requires a Black Box warning due to the overwhelming evidence of severe mental health side effects, including suicidal thoughts or actions, agitation, hallucinations, and depression.”³
Review & document patient education
Documented patient education is key to providing informed care. Each medication has unique side effects. It is essential to inform patients of potential consequences so they can make informed decisions. Sites should review provider documentation to ensure patients have been properly educated.
Ensure patients understand. If the documentation reads: “patient was provided a medication guide listing the potential for serious and lasting neuropsychiatric injuries that can persist even after medication has been discontinued,” did they receive proper education? Tell them about black box warnings in terms they understand.
If a provider determines a medication change is appropriate, it is crucial that the patient and the jail understand why. The reasons for medication changes should be documented and communicated to both the patient and jail administration. Review & document patient education.
Weigh the cost-benefit analysis
Health care professionals should consider potential benefits and drawbacks when deciding to prescribe or continue medications, especially those with black box warnings. A patient-centered, interpersonal approach should be taken when prescribing medication in the jail.
For example, regular suicide screening and risk assessment should be done regularly for detainees taking montelukast. Consider alternatives like over the counter (OTC) allergy medication that may be more appropriate for detainees currently prescribed montelukast. Ensure that providers only prescribe montelukast for patients when alternatives are ineffective or not tolerated. Professionals should carefully weigh the benefits and mental health side effects before prescribing montelukast for asthma.
If a patient comes into the jail with a black box medication like montelukast, consider their individual situation. Do not deny a medication at the door just because of a black box warning. There is a potential for side effects when abruptly stopping a medication. Instead, educate the patient and look at their situation holistically. A provider may determine it’s appropriate to keep the prescription, for example if the patient is only going to be in jail for a short time. Instead, educate and advise the detainee to stop the medicine and contact a doctor immediately if they develop symptoms. Weigh the cost-benefit analysis.
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U.S. Food & Drug Administration (2020). FDA Requires Boxed Warning About Serious Mental Health Side Effects for Asthma and Allergy Drug montelukast (montelukast); Advises Restricting Use for Allergic Rhinitis. FDA. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug
Richmond, Mckenzie (2024). FDA ‘Black Box Warning’ Issued, 31 Million Americans Still Prescribed High Risk Drug. ABC News Channel 8. https://ktul.com/amp/news/local/fda-black-box-warning-issued-31-million-americans-still-prescribed-high-risk-drug-asthma-lungs-health-montelukast-side-effects-allergies-kids-mental-health
OSU Extension (2020). Side Effects of montelukast/montelukast. The Ohio State University. https://warren.osu.edu/program-areas/family-and-consumer-sciences/healthy-people/side-effects-montelukastmontelukast
Disclaimer
All materials have been prepared for general information purposes only. The information presented should be treated as guidelines, not rules. The information presented is not intended to establish a standard of medical care and is not a substitute for common sense. The information presented is not legal advice, is not to be acted on as such, may not be current, and is subject to change without notice. Each situation should be addressed on a case-by-case basis. When in doubt, send them out!®