New York Attorney General Urges FDA Action On Widely Used Asthma Drug's Concerns Over Pediatric Safety
Portfolio Pulse from Vandana Singh
New York Attorney General Letitia James has requested the FDA to investigate the safety of the asthma and allergy medication Singulair (montelukast), particularly its neuropsychiatric side effects in children. Despite a 'black box' warning added in 2020, there are concerns about the adequacy of current warnings, especially for pediatric patients. Merck & Co Inc (MRK), the original manufacturer, and Organon Inc (OGN), which now markets Singulair, are highlighted due to the drug's significant revenue and the lawsuits alleging they downplayed psychiatric risks.
February 26, 2024 | 3:56 pm
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Merck & Co Inc, the original manufacturer of Singulair, faces scrutiny over the drug's safety and lawsuits alleging downplayed psychiatric risks.
The call for FDA action and the highlighting of lawsuits against Merck for allegedly downplaying psychiatric risks could negatively impact investor sentiment and potentially lead to regulatory actions or settlements. This situation puts a spotlight on Merck's responsibility and could affect its stock price in the short term.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80
NEGATIVE IMPACT
Organon Inc, which now markets Singulair, is implicated due to concerns over the drug's safety profile and its neuropsychiatric side effects in children.
Organon's association with Singulair, especially as the current marketer of the drug, places it in a challenging position. The focus on the drug's safety for pediatric patients and the potential for increased regulatory scrutiny could negatively impact Organon's stock price in the short term, as it may affect sales and increase legal and regulatory costs.
CONFIDENCE 80
IMPORTANCE 70
RELEVANCE 70