FDA Committee Recommends OTC Sale of Claritin to Treat Hives
The FDA's Nonprescription Drugs Advisory Committee voted unanimously yesterday to recommend that Schering-Plough Corp.'s prescription allergy drug Claritin be sold over the counter to treat recurring hives, the Wall Street Journal reports. Company representatives yesterday said nonprescription Claritin could "help U.S. patients" and cited successful over-the-counter drug sales in Canada and the United Kingdom. Yesterday's decision comes a year after Schering-Plough told the same committee that over-the-counter sales of Claritin could "endanger" U.S. patients and that Canada and the United Kingdom could not be used as models because those countries' health systems differ from the U.S. system (Harris, Wall Street Journal, 4/23). Nonetheless, the committee last year said that Claritin -- as well as the allergy drugs Allegra, made by Aventis, and Zyrtec, made by Pfizer -- should be sold over the counter to treat nasal allergies. The FDA, which accepts the committee's previous recommendations "most of the time," has been "hampered" by a delay in naming a new commissioner and has not yet ruled on the committee's recommendation, the New York Times reports. The committee's two recommendations to make Claritin, which is scheduled to lose patent protection in December, available over the counter are important because, if approved by the FDA, the move would stop generic drug companies from selling prescription versions of Claritin, or loratadine, the New York Times reports. Drug makers Johnson & Johnson, Novartis and Wyeth have said they plan to market generic versions of Claritin after its patent ends. Schering-Plough spokesperson Robert Consalvo said, "Any generic version would have to be an over-the-counter version. You can't sell the exact same product both over the counter and by prescription" (Freudenheim, New York Times, 4/23).
By the time Claritin loses patent protection in December, Schering-Plough is hoping doctors will have switched many patients with allergies to the company's new prescription drug, Clarinex, USA Today reports. According to the company, Clarinex, or desloratadine, is "longer-acting" than Claritin. In addition, the FDA has approved Clarinex to treat indoor allergies in addition to outdoor allergies. Claritin is only approved for outdoor allergies. But USA Today reports that "it's not clear whether Clarinex ... works any better than tried-and-true Claritin." Raymond Woosley, dean of the University of Arizona College of Medicine, said, "All these allergy claims are pretty hocus-pocus. Indoor allergy versus outdoor allergy? Come on. Clarinex is just a breakdown product of Claritin. When you take Claritin, there's a lot of Clarinex in your blood." USA Today reports that a "big difference" between over-the-counter drugs and prescription medications is whether consumers or insurance companies pay for them (Rubin, USA Today, 4/23). WellPoint Health Networks, a California-based HMO, petitioned the FDA to make Claritin available over the counter and is doing likewise with Clarinex, the Times reports. However, Neil Sweig, a pharmaceutical analyst at Fulcrum Global Partners, said the FDA would "wait for several years" to make sure Clarinex is safe for nonprescription use (New York Times, 4/23).