ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Tuesday, January 14, 1997 TAG: 9701140065
SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: ASSOCIATED PRESS
THE POPULAR ALLERGY MEDICINE can cause dangerous side effects that newer versions don't. The manufacturer says the drug is still safe, however, and will fight the proposed ban.
The Food and Drug Administration proposed withdrawing approval for the nation's No.2 allergy drug, Seldane, on Monday because of potentially deadly side effects.
Seldane's maker plans to fight the action but is urging doctors to switch patients to a safer version of the drug. Hoechst Marion Roussel, which makes Seldane, also manufactures Allegra, which has Seldane's benefits without the side effects.
The Kansas City, Mo., company said 4.3 million prescriptions were written for Seldane from January through November last year and 2.3 million for a variation, Seldane-D.
The company has 30 days in which to request a hearing on why terfenadine, Seldane's generic name, should not be taken off the market. Forty million Americans suffer from allergies.
When it was introduced in 1985, Seldane was the first drug to relieve the sneezing, watery eyes and runny nose of seasonal allergies without drowsiness. But in 1992, doctors discovered that people with liver disease or who took ketoconazole, an antifungal agent, or erythromycin, an antibiotic, could suffer heart rhythm problems by taking Seldane.
In July, the FDA approved Allegra, known generically as fexofenadine.
This month, the FDA approved a generic version of Seldane made by IVAX Corp. of Miami. The FDA said that product would be subject to the same withdrawal order if it becomes final. IVAX spokesman Joe Jones said the company plans to challenge the withdrawal.
``This is not a common event or a common series of events,'' said David Saks, a health care industry analyst with Gruntal & Co. in New York. ``The FDA says that the drug is no longer safe. It puts [Hoechst Marion Roussel] in an awkward position. What do you do with the inventory outside of the United States?''
He said that in the United States, the withdrawal would be a plus for sales of Allegra.
Hoechst Marion Roussel spokesman Charles Rouse said, ``We will go through whatever steps are necessary to defend the fact that Seldane should remain on the market, as long as it is taken as labeled.''
Seldane long ago yielded the market lead to Claritin, made by Schering-Plough Corp.
The FDA said that educational campaigns by Hoechst Marion Roussel and the FDA ``have reduced inappropriate prescribing and dispensing of terfenadine with other drugs,'' but ``such events have not been, and almost certainly cannot be, eliminated.''
LENGTH: Medium: 58 linesby CNB