STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report
Experts say that the Singulair incident highlights a flawed system — both in the U.S. and globally — for monitoring adverse reactions after a drug is on the market.
After a drug enters the market, it’s up to Food and Drug Administration regulators to ensure its continued safety and efficacy. A recent suggests that, in the case of the popular asthma drug Singulair, the FDA fell short — both because the agency delayed action for years on reports from patient advocates and independent groups that the drug could cause suicidal thoughts, and because when it did add a warning label about its potential side effects in 2020, clinicians and patients still weren’t always aware of the risks.
