The FDA Warned an Asthma Drug Could Induce Despair. Many Were Never Told.


In The New York Times, Christina Jewett and Benjamin Mueller report on the widespread prescription of the asthma drug Singulair despite severe known harms including suicidality, especially among children—and despite a black-box warning added decades after the drug was first marketed amid early indications of the risks: 

“In early 2020, the FDA responded to decades of escalating concerns about a commonly prescribed drug for asthma and allergies by deploying one of its most potent tools: a stark warning on the drug’s label that it could cause aggression, agitation and even suicidal thoughts.

The agency’s label, which was primarily aimed at doctors, was supposed to sound an alert about the 25-year-old medication, Singulair, also known by its generic name, montelukast. But it barely dented use: The drug was still prescribed to 12 million people in the United States in 2022.

Children face the greatest risks of the drug’s ill effects, and while usage by minors did decline, it was still taken by 1.6 million of them — including Nicole Sims’s son. Ms. Sims had no idea why, at 6, her son started having nightmares and hallucinations of a woman in the window. When he told her that he wanted to die, Ms. Sims went online, desperate for answers.

Only then did she learn about the FDA warning. She also found a Facebook support group with 20,000 members for people who had experienced side effects of the drug. Members of the group recounted a haunting toll that they linked to the drug with the help of peers, not their doctors.

‘It’s a mental health crisis that nobody is recognizing,’ said Anna Maria Rosenberg, an administrator of the group.

The FDA’s handling of Singulair illustrates systemic gaps in the agency’s approach to addressing troubling side effects from medicines approved long ago — and to warning the public and doctors when serious issues arise. The agency had flagged the 2020 warning label, known as a ‘boxed warning,’ to physicians’ groups, but it had not required that doctors be educated about the drug’s side effects.

Federal regulators in 1998 initially dismissed evidence that emerged during the approval process about the drug’s potential to affect the brain and did not revise their assessment until two decades later. The FDA was slow to alert the public as reports of psychiatric problems surfaced, highlighting deficiencies of a drug-monitoring system that puts the onus on drugmakers to report problems.”

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