In March 2020, the Food and Drug Administration (FDA) issued a black box warning, the highest level of safety warning, for the commonly prescribed asthma medication Singulair (montelukast). The warning addressed long-standing concerns about the drug's potential mental health side effects, including aggression, agitation, and suicidal thoughts. However, a recent report by the New York Times reveals that despite the warning, millions of Americans continue to be prescribed the medication.

According to data obtained from healthcare analysis company Komodo Health, a staggering 12 million people in the United States, including 1.6 million children, were prescribed Singulair in 2022. This is concerning, as experts emphasize that children are particularly vulnerable to experiencing the side effects of the drug.

The FDA's intention behind issuing the warning was to ensure that doctors who prescribe Singulair would inform their patients about the potential mental health risks. However, it appears that very few patients were informed about these risks, raising questions about whether the warning reached enough doctors and patients.

The New York Times report also highlighted the existence of a Facebook support group called the Montelukast (Singulair) Side Effects Support and Discussion Group, which has over 20,000 members. The group serves as a platform for individuals to share their personal experiences regarding the side effects of the medication. Astonishingly, members of the group have discovered the link between their side effects and the drug themselves, rather than through their healthcare providers.

Dr. Reshma Ramachandran, an assistant professor and family doctor at Yale University, expressed concern over the lack of awareness among doctors regarding the FDA warning. She stated that the information has not reached channels that doctors typically notice, and called for more direct communication from the FDA to clinicians through active channels.

Organon, the pharmaceutical company that produces Singulair, maintained confidence in the safety and efficacy of their medication. They stated that they take reports of adverse events seriously and continually monitor the drug's safety. Organon urged patients to discuss any concerns with their healthcare provider and assured that they have provided complete and appropriate information about Singulair's benefits, risks, and reported adverse reactions.

The report raises serious questions about the effectiveness of the FDA's warning and the need for improved communication to ensure that doctors and patients are fully informed about the potential mental health risks associated with Singulair. The fact that millions of people are still being prescribed the drug despite these concerns further highlights the need for increased awareness and vigilance when it comes to medication safety.

As the use of Singulair continues to be widespread, it is crucial for healthcare providers and regulatory agencies to prioritize the safety and well-being of patients by ensuring that information about potential side effects is effectively communicated and understood.