When people are prescribed a drug, the U.S. Food and Drug Administration should ensure they understand if it’s been found to have serious side effects, rather than leaving them to pore over a lengthy litany of packaging warnings.
Case in point: Many people have felt depressed to the point of wishing they would die after taking an asthma drug called montelukast, which goes by the brand name Singulair. But often, neither they nor their doctors realized where that feeling was coming from.
Keeping up with every warning that a new risk has been discovered for an old drug is not easy for doctors, who are busy.
The FDA needs to do a better job of ensuring health care providers know about serious side effects of medications and making sure patients get that information. In 2020, the FDA did issue a “black box warning” for Singulair.
That’s the FDA’s highest safety-related medication warning, but as a New York Times investigation showed last week, the agency needs to do a better job of streamlining the process that gets the word out to doctors. Doctors not knowing of a black box warning has happened in the past. This time, the black box warning went out more than two decades after the drug launched in 1998, but many doctors still did not know.
The reported possible side effects of Singulair include agitation, aggression, depression, sleep disturbances and suicidal thoughts; the drug is especially risky for children. While the FDA notified physician groups about the side effects, it didn’t require doctors to be educated about them. And though the medication’s packaging warned of side effects, it appears many patients had to sort out the significance of the warnings on their own without having been clued in by their doctors about how significant the risks were.
That’s not an effective system, because many patients either don’t read warning information or don’t understand it.
The need for asthma treatment is great. According to the New York Times, 12 million people in the U.S., including 1.6 million children, were prescribed the drug in 2022. In Chicago, 16% of families have a child or children with asthma, which is higher than state and national childhood asthma rates, according to a 2020 Voices of Child Health in Chicago report.
Singulair undoubtedly has helped many people treat their asthma without serious side effects, and it has also been used to treat allergies or allergic rhinitis. But it’s the FDA’s job to figure out how to make sure doctors and patients know the risks.
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