Even after the FDA issued a warning in 2020 about the adverse effects linked to Singulair, a now generic asthma drug, and strengthened its warning in 2022, physicians continue to prescribe it to millions of patients.
Among the range of reported side effects like aggression, suicidal thoughts and even hallucinations, children are generally the most at risk of experiencing them, The New York Times reported on Jan. 9. However, millions of children are also still prescribed it.
The warning label that the FDA hoped would grasp the attention of prescribing clinicians may have done so, but patients seem to more commonly learn of the side effects through word of mouth, friends and online support groups rather than their clinicians, according to theTimes.
Clinicians, though, argue that the FDA has not done enough to break through to direct channels where the prescribers could more quickly and easily see this information.
The FDA "needs to do much more in terms of direct communication to clinicians and through more active channels," Reshma Ramachandran, MD, a Yale University assistant professor and family doctor, told the Times.
While the agency did ask pharmacists to provide updated warning information with the drug to consumers in 2020, send an alert email and shared the information with patient and provider groups, it did not require "monitoring of side effects", which as an agency it does have authority to invoke, and which some say should have been the case.
The studies are ongoing related to the many reported psychiatric symptoms associated with the drug, and the FDA notes it "continues to monitor and investigate this important issue."