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.
On March 4, 2020, the FDA required Singulair to carry a “black box” label — the FDA’s most serious warning, for “serious mental health side effects,” according to Drugwatch.
Black box warnings list “important side effect information surrounded by a thick black border and bold lettering to warn of permanent, serious or fatal side effects.”
In the case of Singulair, the label links the drug to “suicide, depression, aggression, agitation, suicidal thoughts and sleep disturbances.”
The black box label was at least two decades in coming, according to Hazlehurst, who said it “took over a decade’s worth of work by persistent parents, armed with overwhelming evidence of the serious neuropsychiatric side effects, urging the FDA to take action.”
According to Drugwatch, lawsuits now pending against Merck claim the drugmaker “knew or should have known before it started selling Singulair in 1998 that the drug could cause neuropsychiatric injuries during treatment and even after stopping.”
Dr. Liz Mumper, a pediatrician, said she has been “aware of the potential neuropsychiatric side effects of montelukast for many years,” adding that her patients “are instructed to stop the medicine if they notice a change in their mental health.”
“Over the years, parents have reported personality changes in their children, rapid changes in mood and irritability,” Mumper told The Defender. “Typically, these symptoms resolve once off montelukast.”
Since March 2020, when the FDA applied the black box warning to Singulair, numerous lawsuits have been filed against Merck. The lawsuits allege Merck designed “a defective drug,” in addition to claiming “negligence and failure to warn about the risk of mental problems,” according to Drugwatch.
A Reuters investigative report revealed the lawsuits also allege “that the company’s own early research indicated the drug could impact the brain but that Merck downplayed any risks in statements to regulators.”
The Reuters investigation states that plaintiffs faced a legal hurdle commonly used by Big Pharma — known as a “preemption defense” — based on a legal argument that federal law and federal regulations supersede state laws, including state product liability laws that traditionally served as the basis for lawsuits like those against Merck.
As a result, “companies increasingly argue that federally regulated products or services should be immune from lawsuits alleging state-law violations,” and plaintiffs “must often demonstrate that a company failed to disclose safety information to federal regulators — and that the information could have spurred new government restrictions or warnings before the alleged harm occurred.”
This has made it particularly difficult to sue manufacturers of generic versions of Singulair and other drugs, because generic drugmakers simply follow the primary manufacturer’s FDA-approved labeling, while the primary drugmaker can’t be sued by claimants if they or their family members took the generic version.
Perro told The Defender that a combination of an abrogation on the part of federal regulators, a lack of integrity on the part of drugmakers and complex legal maneuvering makes it difficult for doctors to prescribe safe treatments to their patients.
She said:
“A medical practitioner now needs to understand their patient, the illness, any prescribed medications, what Pharma reports about their drug, the real science behind the drug, and unfortunately, the legal doctrine of preemption, which is the principle based on federal law trumping state law.
“It is a dark time in medicine when the physician must question the integrity of what is written on the prescription pad.”
The FDA claims it has “diligently monitored reports of side effects possibly associated with montelukast, as well as communicated findings and taken regulatory action, when appropriate,” and that it “continues to monitor and investigate this important issue.”
Merck’s patent on Singulair expired in 2012, allowing generic drugmakers to begin producing and marketing the drug. Still, according to Reuters, Singulair “has provided Merck with about $50 billion in revenue.”
However, once Merck’s patent expired, “The number of patients prescribed the medicine climbed from about 7 million annually to more than 9 million” — with up to half of recipients age 16 or younger.
Read More: Merck Knew Its Popular Asthma Drug Could Lead Kids to Commit Suicide
