The U.S. Food and Drug Administration’s Nonprescription Drugs Advisory Committee should recommend that the agency reject montelukast, also known as Singulair Allergy, for over-the-counter sale, Public Citizen said Friday.
Singulair, now available only by prescription, was approved in 1998 by the FDA for treatment of asthma in patients 15 years and older. Later, the FDA approved it for the relief of seasonal allergic rhinitis in adults and children six months and older and to treat asthma in children as young as 12 months.
Public Citizen believes Singulair shouldn’t be available over the counter because:
- There’s no evidence that the treatment is more effective than, or even as effective as, the existing FDA-approved over-the-counter allergy medications.
- There’s no evidence that it provides any additional benefit when combined with other treatments.
- It poses a significantly greater risk compared to existing over-the-counter allergy medications. Among the side effects are agitation, aggressive behavior, anxiety, depression, hallucinations, insomnia, irritability, and suicidal thoughts.
If consumers could buy Singulair without a prescription, the potential for inappropriate and potentially dangerous use is high, Michael Carome, M.D., director of Public Citizen’s Health Research Group, said.
Between 30 million and 60 million people in the United States have allergies, and studies show that many consumers misunderstand who the over-the-counter Singulair is intended for, Carome said.
With aggressive advertising by Singulair’s manufacturer, Merck, he said, it’s certain that many people who shouldn’t take the medication without consulting a doctor, such as patients with asthma and children with allergies, will use it without understanding the dangers.
“With allergies affecting as much as 30 percent of U.S. adults, there is a high likelihood that people who shouldn’t be taking it will use it and place themselves in harm’s way,” said Carome. “No other country has approved montelukast for sale over the counter. The FDA should not make the mistake of allowing the United States [to] be the first to do so.
