The European Medicines Evaluation Agency warned last month that an allergy drug called desloratadine may cause birth defects, and that concerns a local allergist.
“I think this drug raises real concern for not only pregnant women, but also for all women able to conceive,” says Dr. Matthew C. Wilson.
The medication is sold under various brand names including Clarinex in the United States and Neoclarityn, Aerius, Opulis and Allex around the world.
The EMEA was asked to review the drugâ€™s safety after Swedish authorities reported 15 cases of hypospadias, a condition that causes male babies to have malformed penises, among 2,780 births.
The problem affected boys born to women who had been using Claritin, the generic name of which is loratadine, an antihistamine. Desloratadine is a derivative of loratadine, and both are being examined.
Schering-Plough said the Swedish conclusions “are based on flawed methodology and analysis that underscores the inherent limitations of drawing conclusions based on a comparatively small number of cases.”
The company pointed out that there have been no reports of hypospadias associated with desloratadine, but it has agreed to change its labels to warn against use by pregnant women.
Thatâ€™s not enough to relieve Wilsonâ€™s concerns.
“Claritin has recently gone over-the-counter, and now is widely available to all populations in liquid form as well as tablets and RediTabs,” he says. “Also, West Virginia Medicaid has placed Claritin as well as Clarinex on its preferred list of medications. In fact, Medicaidâ€™s drug formulary for antihistamines includes only Schering products.”
The U.S. Food and Drug Administration and Health Canada have opened their own probes of the medication.