FDA Panel Says No to OTC Singulair
(HealthDay News) — A panel of expert advisors to the U.S. Food and Drug Administration on Friday voted overwhelmingly against moving the allergy drug Singulair from prescription to over-the-counter status.
The panel voted 11-to-4 against the sale of the popular medication without a doctor's approval, the Associated Press reported. According to the AP, many on the FDA panel felt there were still questions over the safety of making Singulair available without a prescription, especially because some patients would be using it for "off-label" treatment of conditions such as asthma. The FDA does not have to follow the advice of its expert panels, but it usually does.
"My discomfort about Singulair being sold over the counter mirrors the FDA's concern that it may be used inappropriately for the treatment of asthma," Andrew Ting, MD, an assistant professor of pediatrics, pulmonary, and critical care at The Mount Sinai Hospital in New York City, told HealthDay. "The selection of Singulair over an inhaled corticosteroid for asthma prevention is a decision that should only be made by trained medical professionals," he said. "The risk of asthmatics using Singulair as a rescue medication or in place of an oral corticosteroid such as prednisone could lead to a significant delay in appropriate treatment for exacerbations."
Harlan Weinberg, MD, director of pulmonary medicine and pulmonary rehabilitation at Northern Westchester Hospital in Mt. Kisco, NY, echoed these concerns to HealthDay. And he noted, "there are no well-controlled studies in pregnant women or with breast-feeding, for determining fetal or infant risk."