New York attorney general urges stronger safety warning on asthma drug
Singulair
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[February 24, 2024]
By Robin Respaut and Dan Levine
(Reuters) - The attorney general for one of the most populous U.S.
states this week urged federal drug regulators to address safety risks
associated with the widely used asthma and allergy medicine Singulair,
saying current warnings on the drug's packaging are insufficient,
particularly for children.
In a letter dated on Wednesday, the New York state attorney general's
office urged the U.S. Food and Drug Administration to further
investigate and warn consumers and healthcare providers about harmful
neuropsychiatric side effects of Singulair, also known by its generic
name montelukast.
The office told the FDA that the effects of Singulair on children are a
"particularly urgent concern in light of the national youth mental
health crisis plaguing our state."
FDA spokesperson Chanapa Tantibanchachai on Friday said the agency would
respond directly to Attorney General Letitia James. A spokesperson for
Merck & Co spinoff Organon, which currently markets Singulair, did not
immediately respond to a request for comment.
The letter cited a report from Reuters last year that found the FDA had
received thousands of reports of patients, including many children,
experiencing depression, suicidal thoughts and behaviors, or other
psychiatric problems after taking Singulair or generic montelukast,
since the drug was launched by Merck over 25 years ago.
The Reuters report also detailed lawsuits alleging Merck 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.
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A sample of the drug Singulair made by Merck & Co. is seen in New
York March 9, 2009. REUTERS/Chip East/File Photo
In 2020, the FDA added its most
serious warning, known as a "black box," to the drug's label,
describing serious neuropsychiatric events reported by patients
taking the medicine.
The AG's office asserted that four years after the warning was added
to the drug's label, the prevalence of adverse mental health events,
including suicide, continued to be widely reported
disproportionately for pediatric patients, and that many healthcare
professionals and patients are still unaware of the potential
serious side effects.
The AG urged the FDA to investigate whether the risk of Singulair's
adverse side effects outweigh its benefits for pediatric patients,
and to notify healthcare providers of the drug's safety risks to
minors. The AG's office also suggested the FDA encourage providers
to consider alternative FDA-approved medications for asthma and
allergies in children and adolescents.
Singulair, one of the best-selling drugs in U.S. history, provided
Merck with about $50 billion in revenue, company disclosures show.
Millions of prescriptions of the drug have also been written for
generic versions of Singulair.
(Reporting by Dan Levine and Robin Respaut; Editing by Bill Berkrot)
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