"Due to the wide availability of alternative safe and effective allergy medicines with long histories of safety, we have reevaluated the risks and benefits of montelukast and have determined it should not be the first choice treatment particularly when allergic rhinitis symptoms are mild," said the FDA this week about the allergy and asthma drug marketed as Singulair.
Concerns about steady reports of suicide and other neuropsychiatric events moved the FDA to add a "boxed warning" also called a "black box" warning this week.
"Boxed warnings" are the strictest FDA label warnings. They appear on cigarettes, fluoroquinolone antibiotics like Cipro and Levaquin, the acne drug Accutane for birth defects and other products with well-known risks.
Pharma dislikes boxed warnings since they reduce sales (though their lobbyists charge the boxes "confuse" and "unnecessarily alarm" patients). So it was no surprise that when the FDA held a Joint Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees on September 27, 2019 to address growing reports of neuropsychiatric events from montelukast in pediatric patients there was a lot of talk about boxed warnings.
Singulair was Merck's biggest seller when on patent, bringing in $3.3 billion in 2011 and named one of Kiplinger's 15 all-time best-selling prescription drugs. Merck used Scholastic, the educational publishing group, the American Academy of Pediatrics and Olympic gold-medalist swimmer Peter Vanderkaay to help market it.
Testifying at the hearings were parents whose children had taken their own lives on the drug or experienced other severe harm. The parents, from groups like Parents United for Pharmaceutical Safety and Accountability and the Montelukast Side Effects Support and Discussion Group, asserted that a boxed warning would prevent future tragedies. Up until now, the montelukast label only warned against "neuropsychiatric events."
Many Safety Signals Have Followed the Drug
Fox 5 first reported neuropsychiatric events in late 2010 parents seeing aggressive behavior, hostility, hallucinations, night-terrors, tremors, irritability, anxiety, depression and even suicide in their children taking montelukast.
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