Prescriptions of asthma drug montelukast remain high despite warnings from the FDA about psychiatric side effects, The New York Times reported Jan. 9.
The FDA first added a boxed warning to montelukast's label in 2020 that the drug could cause "severe neuropsychiatric side effects," including agitation, aggression, depression and suicidal thoughts or behaviors. The drug was approved in 1998.
Around 12 million people were prescribed montelukast, also known by the brand name Singulair, in 2022, according to the Times. Rates of prescriptions have declined slightly among children and adults since 2018, according to the Times.
Though the FDA issued its warning in 2020, some patient advocates and experts told the outlet the agency should have done more to warn physicians about the side effects of the drug, especially among children.
Reshma Ramachandran, MD, an assistant professor of medicine at Yale University, told the Times the agency "needs to do much more in terms of direct communication to clinicians and through more active channels," about the drug's side effects.
Organon, the manufacturer of Singulair, told the Times the company has communicated the drug's risks and benefits to patients and physicians.
"Nothing is more important to Organon than the safety of our medicines and the people who use them," the company said.
Read more here.