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# NY Attorney General Urges FDA Action on Singulair
- URL: https://www.fdaweb.com/ny-attorney-general-urges-fda-action-on-singulair/
- Published: 2024-02-23T12:00:00.000Z
- Updated: 2026-09-14T14:23:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156417

New York attorney general **Letitia James** is urging FDA to take further safety actions to address the “dangers” of Merck’s asthma and allergic rhinitis drug Singilair (montelukast) and generics, particularly for minor children. Despite FDA four years ago approving a new Boxed Warning for Singulair ([see story](https://fdaweb.com/login.php?sa=v&aid=D5146694&cate=&stid=%241%24wG4.3l3.%24ZYt6%2FcUq6J4RSnDvenQWA%2F&ref=fdaweb.com)), “the prevalence of tragic adverse mental health events, including aggression, depression, and suicide, continue to be widely reported, and disproportionately so for pediatric patients,” James said in a [2/21 letter](https://ag.ny.gov/press-release/2024/attorney-general-james-calls-urgent-action-protect-children-harmful-effects?ref=fdaweb.com) to FDA commissioner **Robert Califf**.

“Parents and guardians have the right to be fully informed of a medication’s potential side effects when making choices about their children’s health,” James emphasized in her letter. “The risks associated with taking Singulair are far too dire to come without a very clear warning.” James says that data reviewed subsequent to the Black Box warning indicate that the potential neuropsychiatric risks of Singulair are higher for children compared to adults.

In her letter, James outlines several key actions for FDA to take, including issuing new drug safety communications, sending targeted communications to healthcare providers, conducting thorough risk assessments, and evaluating additional interventions to mitigate risks associated with Singulair use in children.