Asthma drug FDA warned about given to millions in 2022: Report
- FDA warned Singulair could have psychiatric side effects
- NYT: Despite warning, drug prescribed to millions of people
- Manufacturer says safety is of the utmost importance
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(NewsNation) — An asthma and allergy drug that has been known to cause aggression and suicidal thoughts was reportedly prescribed to millions of people in 2022, despite warnings from federal regulators about the dangerous side effects.
The drug, Singulair, was originally manufactured by Merck and is currently the subject of at least one lawsuit brought by a man who said its usage caused him to develop depression and suicidal thoughts.
The Food and Drug Administration in 2020 ordered a warning be put on the drug’s label, primarily aimed at doctors. However, 12 million people were still prescribed the drug in 2022, according to The New York Times.
At the time the warning was issued, Merck released a statement saying it is confident in the safety of the drug.
“At Merck, we are committed to working with regulators, including the US Food & Drug Administration (FDA), to label our products appropriately, enabling physicians to make informed decisions about the products they prescribe,” the company said. “We remain confident in the efficacy and safety of SINGULAIR (montelukast sodium), a medicine that has been prescribed to tens of millions of indicated patients with asthma and allergic rhinitis since its approval more than 20 years ago.”
Singulair is also known by its generic name montelukast. Other companies have sold the generic version since Merck’s patent expired in 2012.
Merck spun the drug off in 2021 to the company Organon, the Times reported, which told the newspaper that “Nothing is more important to Organon than the safety of our medicines and the people who use them.”
Reuters reported last year the FDA had received nearly 5,000 reports of patients experiencing depression or suicidal thoughts after taking Singulair or the generic version.
The FDA in 2020 mandated a “black box” warning be affixed to the drug label, but it didn’t require doctors to receive education nor did it require monitoring of side effects.
Merck faces a raft of lawsuits alleging it knew from its early research that the drug could impact the brain and that it minimized the potential for psychiatric problems in statements to regulators.
Reuters contributed to this story.