Singulair, now a generic, is still used by millions of Americans even after thousands of patients and dozens of studies have described harm. Children face the greatest risks of the drug's ill effects.
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A black box warning, also called a boxed warning, was issued by the FDA in March 2020 about mental health side effects with Singulair, also known by its generic name, montelukast a 25-year-old asthma and allergy drug.
Singulair, now a generic, is still used by millions of people in the United States even after thousands of patients and dozens of studies have described harm.
In early 2020, the Food and Drug Administration 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 u