Singulair’s Boxed Warning Went Ignored. How Do You Know If Your Medications Are Safe?

A recent New York Times investigation has revealed that many people taking a common asthma drug, Singulair (montelukast), were not aware of the potential serious mental health side effects of the drug. The story is raising questions about how patients can be better informed of the risks of taking a medication as prescribed.

The Food and Drug Administration (FDA) issued a boxed warning for Singulair in 2020 after multiple reports and studies showed that the asthma medication could cause serious mental health symptoms, including aggression, agitation, and suicidal thoughts.

Even though the drug got a clear warning label, it was still prescribed to 12 million people in the United States in 2022—and many patients and their families reported being unaware of the risks of taking it.

How can you become better informed about the medications you take? Here’s what experts want you to know.

Why Didn’t People Know About the Risks of Singulair?

It’s not entirely clear why people didn’t know about the risks of Singular, even with a warning label on the drug packaging. The New York Times report detailed two major elements that seemed to contribute to the lack of awareness:

1. The report alleged that Merck, the company that makes Singulair, did not do rigorous enough studies on the possible side effects and appeared to downplay the ones it did find.
2. The report also alleged that the FDA did not do enough to communicate the warnings about the drug to patients and providers.

It’s possible to miss information about potential side effects, even with a boxed warning on the label, Bruce Ruck, PharmD, managing director of the New Jersey Poison Control Center at Rutgers New Jersey Medical School, told Verywell.

“People do not always read the information that comes with the medication,” said Ruck, adding that many people also don’t ask about potential side effects of their medications.

It seems like there were probably multiple gaps in the line of communication—providers may have missed the communication from the FDA, and then, in turn, not passed on that info to patients.

Even if they missed the updated warning, Toni Larson, PharmD, a clinical pharmacy specialist at Corewell Health, told Verywell that most providers are aware of the risk of neuropsychiatric side effects with Singulair.

In Larson’s experience, “most patients have been counseled on this risk, especially in children/pediatrics as that was where the initial evidence showed the most effects of this side effect.”

Larson added that the risk was and continues to be rare. The pharmacists and clinicians she’s worked with didn’t spend a lot of time discussing the updated warning label because other side effects, like drowsiness, are much more likely, are more likely.

“The benefit of the medication usually outweighs the risks of side effects,” she said.

What Is a Boxed Warning?

A boxed warning, sometimes referred to as a black box warning, is “one of the highest warnings that the FDA will put on a drug,” said Ruck. The warning goes on the front page of the drug information pamphlet that patients get and outlines the potentially serious side effects they need to be on the lookout for.

The warning labels are also displayed on a drug’s package insert, in the Physicians’ Desk Reference, on the FDA’s website, and on the websites of drug marketing companies, according to Larson.

One question raised by the Times report was why providers didn’t seem to change their prescribing practices after the warnings about Singulair were revealed. According to Larson, “Physicians are required to provide patients with information about relevant risks, but they can use professional judgment to decide whether to prescribe a drug with a boxed warning.”

What to Look for on Medication Labels

Experts recommend making sure you are aware of the risks and side effects of every medication you’re prescribed. The drug label and pamphlet have rich information about the medication, according to Jamie Alan, PharmD, PhD, an associate professor of pharmacology and toxicology at Michigan State University. She said that while “side effects are a hot topic,” the labels also include important info on the drug’s “administration, dose, contraindications.”

Larson said you should always carefully read the label of your medication.

"That’s where we tend to find the most differences in how we think people are taking their medication and how they are actually taking their medication,” said Larson. "I also recommend patients always check the description of the medication compared to what the medication in the bottle looks like—it’s one extra step that can make a difference in making sure they are getting the right medication."

How to Learn More About Your Medications

Alan recommends speaking with your healthcare provider to make sure you understand the medications you’re taking, which includes any risks or side effects that you should be aware of.

Ruck agrees.

“I always suggest speaking to your healthcare professional,” he said. “Ask questions like, ‘How do I know if that medication is working for me?’ ‘What do I do if I have a side effect?’ ‘What is the best time of day to take it?’”

Larson recommends talking to the pharmacist when you pick up your medication.

“[The pharmacy] is where a lot of questions can be answered, and a good source of information and reliable resources.”