May 2, 2014
Singulair Is Too Dangerous to Be Available Over the Counter, Public Citizen Tells FDA Advisory Committee
Minimally Effective and Risky Treatment for Allergies Should Be Rejected
WASHINGTON, D.C. – The U.S. Food and Drug Administration’s (FDA’s) Nonprescription Drugs Advisory Committee should recommend that the agency reject montelukast, also known as Singulair Allergy, for over-the-counter (OTC) sale, Public Citizen said in testimony today.
Singulair, now available only by prescription, was approved in 1998 by the FDA for treatment of asthma in patients 15 years and older. Subsequently, 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.
Singulair should not be available OTC because:
There is no evidence that the treatment is more effective than, or even as effective as, the existing FDA-approved OTC allergy medications;
There is no evidence that it provides any additional benefit when combined with other treatments; and
It poses a significantly greater risk compared to existing over-the-counter allergy medications. Among the side effects: agitation, aggressive behavior, anxiety, depression, hallucinations, insomnia, irritability and suicidal thoughts.
If people could buy Singulair without a prescription, the potential for inappropriate and potentially dangerous use is high, Dr. Michael Carome, director of Public Citizen’s Health Research Group, told the committee.
Between 30 million and 60 million people in the U.S. have allergies, and studies have shown that many consumers misunderstand for whom the over-the-counter Singulair is intended. Factor in the expected aggressive advertising by Singulair’s manufacturer, Merck, and it is certain that many people who should not 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 Dr. Michael Carome, director of Public Citizen’s Health Research Group. “No other country has approved montelukast for sale over the counter. The FDA should not make the mistake of allowing the United States be the first to do so.”