A report published in The New York Times this week has renewed attention and criticism on an asthma and allergy drug that has long been alleged to increase mental health issues in patients receiving the treatment.
On Tuesday, the outlet published a story discussing suicidal ideation concerns related to Singulair, an asthma and allergy drug originally manufactured by Merck in 1998.
The drug was a blockbuster success for the company, generating billions in annual revenue from the late 1990s through the early 2010s.
However, as early as 2008, the Food and Drug Administration issued a communication advising that it would investigate a possible risk of suicidality with Singulair. Many of the reports of increases in agitation, aggression, anxiety, depression, suicidal thoughts and hallucinations were for children and adolescents.
Following the drug’s patent expiration in 2012, Merck tried to get Singulair approved to be available over-the-counter. However, an FDA advisory panel voted 11-4 against granting that request in 2014.
Then, in early 2020, the FDA issued a black box warning for healthcare professionals after receiving more than 14,000 reports of patients experiencing side effects from taking the drug, more than 10,000 of which were considered serious.
At the time, Merck issued a statement indicating its commitment to working with regulators to appropriately label its products and enable physicians to make informed decisions about the products they prescribe.
“We remain confident in the efficacy and safety of Singulair (montelukast sodium), a medicine that has been prescribed to tens of millions of indicated patients with asthma and allergic rhinitis since its approval more than 20 years ago. We will work with the FDA to update the labeling for Singulair. Today Merck supplies only a small portion of the overall market,” the statement read.
In 2021, Merck offloaded the drug, by then a generic, to its spinoff Organon. Despite these well-documented psychiatric risks. The Times said the drug was prescribed to 12 million people in 2022.
Organon responded to The Times’ request for comment by saying “nothing is more important” to the company “than the safety of our medicines and the people who use them.”
The Times story came about six months after Reuters reported that Merck downplayed early evidence of the drug’s impact on patients’ brains. The drugmaker — which currently faces numerous lawsuits alleging it knew the drug could affect the brain and minimized the potential risk for developing psychiatric problems — declined to comment to the outlet for that story.
In a separate report published last year, Reuters also stated the FDA received almost 5,000 reports of patients experiencing depression or suicidal thoughts after taking Singulair or its generic version.
The 988 Suicide and Crisis Lifeline is a hotline for individuals in crisis or for those looking to help someone else. To speak with a trained listener, call 988. Visit 988lifeline.org for crisis chat services or for more information.
