FDA Says Seldane Unsafe, Suggests Ban

WASHINGTON -- The popular antihistamine Seldane is unsafe and should be taken off the market, the Food and Drug Administration announced Monday.


Since its introduction in 1985, the drug has been blamed for perhaps hundreds of deaths resulting unstable heart rhythms when it's taken with the common antibiotic erythromycin or with the antifungal drug ketoconozole, the FDA said. Patients with liver disease have also reported abnormal heart rhythms when taking Seldane alone.


The agency suggested that users talk with their doctors about switching from Seldane, also known as terfenadine, to another prescription antihistamine approved in July 1996, Allegra (fexofenadine). Allegra has the same beneficial effects as Seldane without any of the harmful side effects, said Robert Temple, director of the FDA's Office of Drug Evaluation. Both drugs are manufactured by Hoechst Marion Roussel.


Pharmacists wrote 6.5 million prescriptions for Seldane products between January and November of last year, according to Hoechst. FDA officials said they hoped to withdraw the approval for Seldane immediately after the 30-day comment period following Monday's announcement. The move would apply to Seldane, Seldane-D -- which includes the drug psuedoephedrine -- and generic versions of the drug, one of which was only approved for sale by the agency this month.


Any such action could be delayed if Hoescht fights the withdrawal, however, and company officials indicated that they would do so. "We fully intend to fight any challenge to remove Seldane and Seldane-D from the market,'' said company spokesman Charles Rouse III. "Seldane is a safe and effective product when taken in accordance with product labeling.'' At the same time, the company has kicked off a new initiative to encourage consumers to switch to Allegra.


Seldane was the first anti-allergy drug approved that doesn't make most users drowsy. Because Seldane's potentially dangerous interactions with other drugs have long been known, regulators and Hoechst have repeatedly issued warnings to doctors, pharmacists and patients to avoid taking the antihistamine with those other drugs.


Such warnings have caused the number of Seldane-related incidents to drop sharply over time. "This is not about bodies all over,'' Temple said. Instead, Temple said, the FDA is moving to cut off the one or two needless deaths that still occur each year.


But recent surveys have shown that some doctors and pharmacists have not gotten the message and continue to prescribe the potentially fatal combinations. Also, Temple said, even if pharmacists and doctors prescribe the drug properly, consumers keep the bottle in the medicine chest and might use it whenever they feel an allergy attack coming on, without regard to other drugs they might be taking at the time.


A consumer health advocate Monday said that the FDA and Hoechst had not acted quickly enough to take Seldane off the market and should have done so as soon as an alternative was available. "A responsible company would have recalled all supplies of Seldane,'' said Sidney Wolfe, executive director of Public Citizen's Health Research Group. Other over-the-counter products are equally effective for many patients, said Wolfe, who suggested the drug should be recalled, a more drastic step that requires removing the product from store shelves. "The drug shouldn't be around at all, period.''