Merck Facing Lawsuits for Allegedly Hiding Severe Psychiatric Side Effects of Asthma Drug

Pharmaceutical company Merck & Co. Inc. is facing lawsuits that accuse the firm of downplaying potential negative psychiatric effects of its asthma medication Singulair, including thoughts of suicide. Singulair, also known as montelukast, was launched by Merck in 1998, with the product label stating that the drug’s distribution in the brain was “minimal.” The company also did not mention any psychiatric side effects that could result from consuming the medication. More than two decades since, several reports of neuropsychiatric problems have popped up among patients who used Singulair, including children. Side effects include hallucinations, suicidal thoughts, and depression. Merck is now facing multiple lawsuits insisting that the company knew early on that the medication could affect the brain, and that Merck lied to regulators about potential psychiatric side effects. In its 1996 patent for Singulair, Merck stated that the drug could be used for treating cerebral spasms, a neurological condition. Plaintiffs argue that this is proof of the company having knowledge about Singulair’s potential effects on the brain. Following the 1998 launch, numerous reports of neuropsychiatric problems among users began to hit internet forums as well as the U.S. Food and Drug Administration’s (FDA) early warning system. FDA Takes Closer Look In a 2019 advisory panel meeting convened by the FDA, the agency tallied 82 suicides that were linked to Singulair or its generic versions. Among the suicide reports, the ages of the victims were provided in 64 cases, and 31 of them were 19 years old or younger. Singulair has made Merck about $50 billion in revenues. Lawsuits against Merck cite research conducted by cell biologist Julia Marschallinger, who has analyzed the drug with her colleagues at Austria’s Institute of Molecular Regenerative Medicine. A 2011 investigation by the team found reports that the drug induced psychiatric side effects like hallucinations, depression, and agitation, suggesting the medication affected the brain. In 2014, the team analyzed Merck’s original animal studies of the drug and discovered that except for the brain, the medication disappeared from all parts of the body within 24 hours of ingestion. In the brain, the presence of the drug rose over time, eventually exceeding the amount in both the lungs and blood. Marschallinger reported that there was a “substantial amount” of drug that reached the brain, contradicting Merck’s claim that the presence of the drug in the brain was minimal. The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images) In March 2008, 10 years after the launch of Singulair, the FDA announced that it was investigating the drug for “possible association” with mood changes and suicidality. In August 2009, the FDA said that it had updated the precautions section of Singulair, stating that neuropsychiatric events had been reported in patients using the drug. “The events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms,” the agency said. New Warning In 2014, the FDA convened a panel to consider Merck’s request to allow Singulair to be offered over the counter. The agency asked the company to reanalyze its clinical trial data from 2009. Merck reported that one case of attempted suicide and another case of hospitalization for suicidal thoughts were reported among two teens taking the drug. But the trial investigator determined that the adverse events were not related to the medication. Though the FDA rejected Singulair’s over-the-counter request for the drug, it did not insist that the company perform new studies, as neuropsychiatric side effects were a “known safety issue.” In March 2020, the FDA added a black box warning for Singulair—the most severe warning issued by the agency—for serious mental health side effects. Singulair’s prescribing information “already includes warnings about mental health side effects, including suicidal thoughts or actions,” the FDA said at the time. “However, many healthcare professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts.”

Merck Facing Lawsuits for Allegedly Hiding Severe Psychiatric Side Effects of Asthma Drug

Pharmaceutical company Merck & Co. Inc. is facing lawsuits that accuse the firm of downplaying potential negative psychiatric effects of its asthma medication Singulair, including thoughts of suicide.

Singulair, also known as montelukast, was launched by Merck in 1998, with the product label stating that the drug’s distribution in the brain was “minimal.” The company also did not mention any psychiatric side effects that could result from consuming the medication.

More than two decades since, several reports of neuropsychiatric problems have popped up among patients who used Singulair, including children. Side effects include hallucinations, suicidal thoughts, and depression.

Merck is now facing multiple lawsuits insisting that the company knew early on that the medication could affect the brain, and that Merck lied to regulators about potential psychiatric side effects.

In its 1996 patent for Singulair, Merck stated that the drug could be used for treating cerebral spasms, a neurological condition. Plaintiffs argue that this is proof of the company having knowledge about Singulair’s potential effects on the brain.

Following the 1998 launch, numerous reports of neuropsychiatric problems among users began to hit internet forums as well as the U.S. Food and Drug Administration’s (FDA) early warning system.

FDA Takes Closer Look

In a 2019 advisory panel meeting convened by the FDA, the agency tallied 82 suicides that were linked to Singulair or its generic versions. Among the suicide reports, the ages of the victims were provided in 64 cases, and 31 of them were 19 years old or younger.

Singulair has made Merck about $50 billion in revenues.

Lawsuits against Merck cite research conducted by cell biologist Julia Marschallinger, who has analyzed the drug with her colleagues at Austria’s Institute of Molecular Regenerative Medicine.

A 2011 investigation by the team found reports that the drug induced psychiatric side effects like hallucinations, depression, and agitation, suggesting the medication affected the brain.

In 2014, the team analyzed Merck’s original animal studies of the drug and discovered that except for the brain, the medication disappeared from all parts of the body within 24 hours of ingestion. In the brain, the presence of the drug rose over time, eventually exceeding the amount in both the lungs and blood.

Marschallinger reported that there was a “substantial amount” of drug that reached the brain, contradicting Merck’s claim that the presence of the drug in the brain was minimal.

FDA The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)

In March 2008, 10 years after the launch of Singulair, the FDA announced that it was investigating the drug for “possible association” with mood changes and suicidality.

In August 2009, the FDA said that it had updated the precautions section of Singulair, stating that neuropsychiatric events had been reported in patients using the drug.

“The events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms,” the agency said.

New Warning

In 2014, the FDA convened a panel to consider Merck’s request to allow Singulair to be offered over the counter. The agency asked the company to reanalyze its clinical trial data from 2009.

Merck reported that one case of attempted suicide and another case of hospitalization for suicidal thoughts were reported among two teens taking the drug. But the trial investigator determined that the adverse events were not related to the medication.

Though the FDA rejected Singulair’s over-the-counter request for the drug, it did not insist that the company perform new studies, as neuropsychiatric side effects were a “known safety issue.”

In March 2020, the FDA added a black box warning for Singulair—the most severe warning issued by the agency—for serious mental health side effects.

Singulair’s prescribing information “already includes warnings about mental health side effects, including suicidal thoughts or actions,” the FDA said at the time.

“However, many healthcare professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts.”