Dozens of patients, including many children, died by suicide or suffered from neuropsychiatric problems after taking Singulair, Merck’s allergy and asthma medication, according to lawsuits that are finally proceeding, after decades of delays and legal challenges, Reuters reported.

Merck is accused of downplaying early evidence of Singulair’s impact on the brain. These claims “later faced intense scrutiny,” leading to “a raft of lawsuits alleging [Merck] knew … that the drug could impact the brain and that it minimized the potential for psychiatric problems in statements to regulators.”

Singulair, also known as montelukast, is available to adults and children as a medication for severe allergies and asthma. The drug “blocks chemicals, called leukotrienes, in the body,” according to Dr. Michelle Perro, a pediatrician. Leukotrienes “can be involved in the precipitation of asthma and can cause respiratory symptoms, as well as inflammation of the airways,” Perro told The Defender.

Numerous public comments about Singulair’s side effects were submitted in 2019, prior to the Sept. 27, 2019, joint meeting of the U.S. Food and Drug Administration’s (FDA) Pediatric and Drug Safety and Risk Management Advisory Committees charged with reviewing the drug’s safety.

Many of the comments were submitted by “vocal parents” of children adversely affected by Singulair.

Rolf Hazlehurst, senior staff attorney with Children’s Health Defense (CHD), told The Defender he “worked closely” with several of these parents.

The public comments, along with thousands of reports submitted over several years to the FDA Adverse Event Reporting System (FAERS) plus a 2015 research study finding that a “substantial amount” of Singulair entered the brain, forced the FDA to take action.

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