A recent study out of the University of Oklahoma-Tulsa (OU-TU) School of Community Medicine has sparked continued conversation over a U.S. Food and Drug Administration (FDA)-issued Boxed Warning for the asthma drug Singular (montelukast).
In their study, OU-TU researchers sought to understand whether Singulair’s reported negative side effects had decreased since the warning was issued. The study analyzed adverse events reported to the FDA two years before and two years after the warning. According to the study, in children ages one to 10, reports about most harmful side effects decreased after the warning was issued. However, for youth ages 11 to 17, the outcome was mixed. Reports about side effects increased for five of the eight mental health symptoms. Overall, prescriptions for Singulair have decreased only slightly since the warning was issued.
In 2020, the FDA issued a Boxed Warning for Singular after parents reported dramatic and sometimes deadly mental health changes in their children who were using the drug for asthma and allergies. The FDA assigns such warnings to bring attention to the risks of taking the medication. The study, which reported negative side effects and the post-warning results, was published in The Journal of Pediatric Pharmacology and Therapeutics.
“As a clinician interested in public health, I hope we can maximize the intent of these warnings and mitigate potential negative impacts on our patients,” said Samer Abdelkader, DO, a pediatrics resident physician in the OU-TU School of Community Medicine. “I think we can enhance our patient care with better conversations about the benefits and risks of this medication and come to a more informed decision on whether this is the right treatment for each patient.”
Singulair was first approved by the FDA in 1998. It is frequently prescribed for children who have asthma and allergies because it decreases the need for steroids or daily inhaler use. Decades after its approval, however, a large number of parents began reporting serious side effects in their children, including depression, aggression and suicidal thoughts.
In February 2024, the New York attorney general cited the OU study and other research in a letter to the FDA urging the agency to sound a new, louder alarm about the negative side effects of Singulair in children.
One caveat of the study, however, is that the Boxed Warning was issued at the beginning of the COVID-19 pandemic. The pandemic had its own effect on the mental health of young people. Still, OU researchers said their study underscores the importance of parents talking with their child’s doctor before using the drug.
Asthma is the most common chronic disease in children, and hay fever (also known as allergic rhinitis) affects the lives of one in five young people, according to the Centers for Disease Control and Prevention. Singulair treats the inflammation and airway swelling present in both conditions. The drug is approved to treat asthma in children as young as 12 months old and for allergies in babies as young as six months old.
Because new information like a Boxed Warning can take time to make its way into doctors’ offices, OU researchers said health care providers should take the initiative to learn everything they can about the drugs they prescribe
“I no longer say that a side effect cannot be from a medication,” said study co-author and pharmacist Michelle Condren, PharmD, AE-C, a professor and vice chair of research in the OU Department of Pediatrics. “I may say, ‘I haven’t seen this side effect before,’ or, ‘Let me look in the medical literature,’ but I’ll never say that a side effect isn’t possible. This has changed the way I communicate with patients and families. We never want to discount someone who is concerned that a medication could be causing a side effect, but to partner with them to figure things out.”
