Organon's prolific asthma med Singulair needs new safety labeling, NY attorney general argues

Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side effects—especially in kids.

In a letter to FDA commissioner Robert Califf, M.D., James’ office noted that since Singulair received a black box warning in 2020, mental health events like aggression, depression and suicide “continue to be widely reported, and disproportionately so for pediatric patients.”

The attorney general, who has received a lot of media attention since her separate case against President Donald Trump has been hitting the headlines, added that the effects of Singulair on kids are of “particularly urgent concern” given the ongoing mental health crisis affecting young Americans. Of the estimated 12 million people prescribed Singulair, roughly 1.6 million are children, the letter adds.

Organon gained Singulair from Merck when it split off from the New Jersey-based drug behemoth in 2021.

“Nothing is more important to Organon than the safety of our medicines and the people who use them,” an Organon spokesperson said over email. “Reports of adverse events are taken seriously and, as with all of our medicines, we continually monitor the safety of Singulair.”

She noted that Organon remains confident in the medication’s safety and efficacy profile, adding that the company and the FDA have provided patients and healthcare providers with “complete and appropriate” information regarding the safe use of Singulair.

Meanwhile, the FDA plans to respond directly to the attorney general, an agency spokesperson told Reuters.

The FDA has been aware of the risks posed by Singulair for quite some time, James pointed out in her letter. The regulator started communicating its drug safety reviews of the medication to the public in 2008 and in 2014, the agency’s Nonprescription Drugs Advisory Committee rejected an application to approve Singulair for over-the-counter use.

Now, the attorney general is arguing that Singulair’s lack of a specific warning, restriction or contraindication for kids “requires swift action.” Specifically, James wants the FDA to implement new safety labeling changes based on new safety information, including that from adverse event reporting systems.

For all of 2022, Singulair generated $411 million, according to Organon’s annual report from the same period. The medication is one of the best-selling drugs in U.S. history, Reuters pointed out, noting it provided Merck with about $50 billion in revenue over the years.