FDA warns of brain damage risk from popular asthma drug
- The FDA's recent tests revealed that montelukast can bind to brain cell receptors in rats.
- The findings support FDA's decision to discourage prescribing montelukast as a first-line asthma treatment.
- Ongoing research is needed to fully understand the mental health risks associated with montelukast use.
Recent findings presented at the annual American College of Toxicology conference revealed serious concerns regarding the asthma medication montelukast, marketed as Singulair. The new research conducted by the FDA indicated that montelukast could penetrate the brains of test subjects, specifically rats, and bind to various receptors on brain cells. This significant discovery raised alarms about the potential link between the drug and severe mental health effects, including an increased risk of suicide. Historically, these concerns were noted when the FDA received numerous reports that connected montelukast usage to suicidal behavior – notably 82 reports from 1998 to May 2019, with a concerning number involving children under 19 years old. As part of its response, the FDA issued updated labeling requirements, mandating that health professionals and patients be informed of these potential risks. This included adding a black box warning, which is the strongest caution flag that the agency can issue for a prescription medication. Montelukast was originally developed and marketed by Merck, a major pharmaceutical company, but ongoing scrutiny has now led the FDA to advise that doctors should hesitate to prescribe this drug as a primary treatment option for asthma or allergies, particularly in cases of mild symptoms. FDA expert Jessica Oliphant highlighted the locations within the brain where montelukast tends to accumulate, stating that they align with regions associated with psychiatric disorders. While this research elucidates how the medication might impact mental health, significant gaps in understanding remain, including variability in individual susceptibility to these adverse effects. As more studies are necessary to determine the exact mechanisms and risk factors involved, the FDA reaffirmed that the current warning label would remain unchanged for the time being. Meanwhile, Merck's spinoff, Organon, which is now responsible for marketing Singulair, defended the product, asserting that the existing label contains essential information about the benefits, risks, and known adverse reactions associated with the drug. The interplay of pharmaceutical management and public health risks continues to be a pressing concern as healthcare professionals aim to provide safe and effective treatments for chronic conditions like asthma.