Popular Asthma Drug May Cause Serious Mental Health Issues
Singulair, a widely-prescribed asthma drug, may cause serious mental health issues, according to data revealed last week by the U.S. Food and Drug Administration
However, the FDA said it has no plans to update the drug’s label based on the new data.
FDA researchers found that the drug, also sold under the generic label montelukast, attaches to multiple brain receptors critical to psychiatric functioning.
The data support the thousands of patients and dozens of studies that have reported harmful psychiatric side effects, including depression, suicide, anxiety and aggression.
Originally manufactured by Merck, the drug is prescribed for year-round indoor allergies in patients 6 months and up, seasonal outdoor allergies in patients 2 years and up, and for preventing asthma in patients 1 year and older.
Julia Marschallinger, Ph.D., a cell biologist who has studied the drug at the Institute of Molecular Regenerative Medicine in Austria, told Reuters the new data bolster patients’ reports of harm. “It’s definitely doing something that’s concerning,” she said.
The FDA researchers presented their findings — which are preliminary and have not yet been released publicly — during a Nov. 20 meeting of the American College of Toxicology in Austin, Texas.
Their lab tests showed “significant binding” of the drug to multiple brain receptors, according to Jessica Oliphant, Ph.D., a deputy director at FDA’s National Center for Toxicological Research.
“These data indicate that montelukast is highest in brain regions known to be involved in (psychiatric effects),” Oliphant said. The FDA researchers’ findings confirmed prior research that showed montelukast penetrates the brains of rats.
The data do not show whether the binding mechanism leads directly to harmful effects in individual patients or which patients are particularly at risk, Reuters reported.
The FDA said it has no plans to update the drug’s label based on the new data. The FDA did not immediately respond to our request for comment.
According to the Asthma and Allergy Foundation of America, about 4.9 million children under 18 have asthma, making it a leading chronic disease in children. Overall, nearly 28 million — or 1 in 12 — people in the U.S. have asthma.
82 suicides linked to Singulair and its generic versions
In Merck’s early advertisements for Singulair, the company said the side effects were so mild they were “similar to a sugar pill.” However, patients’ lived experiences told a different story.
By last year, the FDA had received thousands of reports from patients — including many children — who experienced depression, suicidal thoughts and behaviors, or other psychiatric problems when using montelukast, Reuters said.
By 2019, the FDA had counted 82 suicides linked to Singulair and its generic versions reported in its adverse event database since 1998. More than a third of those involved someone age 19 or younger.
Reports in the FDA Adverse Event Reporting System, or FAERS, aren’t used to prove a causal link between a drug and a side effect. However, the agency uses the reports to decide if more studies are needed to assess a drug’s risks.
In 2020, the FDA added a “black box” warning on the Singulair and montelukast labels to alert potential users of the drug’s “serious potential side effects.” Around the same time, the agency convened a group of internal researchers to study why the drug might trigger neuropsychiatric side effects.
Although Merck’s profits soared after it launched Singulair in 1998, the drug is now sold by the Merck spin-off, Organon, which told The Defender it is confident of the drug’s safety profile.
The Organon spokesperson said:
“The product label for SINGULAIR contains appropriate information regarding SINGULAIR’s benefits, risks and reported adverse reactions.”
Merck declined The Defender’s request for comment, saying Organon would be the company to comment on issues with the drug.
Meanwhile, Merck is still embroiled in multiple lawsuits alleging the drugmaker knew early on that Singulair could affect the brain, Reuters reported. The lawsuits also allege that Merck minimized the drug’s potential for triggering psychiatric problems in its statements to drug regulators.
New York Attorney General says FDA should do more
Some say the FDA should be doing more to keep the public — especially kids — safe from the drug’s possible harms.
For example, the State of New York Office of the Attorney General in a Feb. 21 letter urged the FDA to “take urgent action” to “prevent further unnecessary health risk.”
The letter stated:
“It has been nearly four years since the U.S. Food and Drug Administration (FDA) strengthened existing warnings regarding the mental and behavioral health side effects of asthma and allergy drug montelukast (brand name Singulair) by imposing a black box warning, the strictest and most serious warning given to medications.
Since that decision in March 2020, the prevalence of tragic adverse mental health events, including aggression, depression, and suicide, continue to be widely reported, and disproportionately so for pediatric patients.
Of the estimated 12 million people prescribed the medication, an estimated 1.6 million are children.”
The New York Attorney General outlined several actions the FDA could take to protect children from the drug’s side effects. For instance, the FDA could issue a “Drug Safety Communication” stating that the FDA is evaluating the risks of using montelukast in children under 18.
The FDA could also send a “Dear Health Care Provider Letter” emphasizing montelukast’s safety risks, particularly for minors, and urging them to consider other medications for treating asthma and allergies in kids and babies ages six months and older.
The FDA also could review all available information to determine whether the risk outweighs the therapeutic benefit in kids and, if not, issue a contraindication warning that the drug shouldn’t be used in children under 18.
The Defender asked the FDA if it had begun implementing — or planned to implement — any of these suggestions but did not receive a response by the deadline.
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Wait a sec…the FDA approved this drug and you mean to tell me none of this was known at the time? That suggests the drug was not properly trialed or tested. This is why the FDA and the CDC are dangerous to your health and part of big pharma murder cult.
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