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FDA MAY PULL PLUG ON SELDANE.

Byline: Harry F. Rosenthal Associated Press

Allergy sufferers who have depended on Seldane to fight off sneezing, watery eyes and runny nose will have to turn to another medicine soon if the government succeeds in pulling the drug off the market.

The Food and Drug Administration proposed withdrawing approval for the second most popular allergy drug because it has 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 company has 30 days in which to request a hearing on why terfenadine, the generic name of Seldane, should not be taken off the market. Some 40 million Americans suffer from allergies.

When it was introduced in 1985, Seldane was the first drug to relieve the effects 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.

Earlier 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 HMR in an awkward position. What do you do with the inventory outside of the United States?''

He said that in the United States, however, the withdrawal would be a plus for sales of Allegra.

Dr. Sidney Wolfe of the consumer advocacy group Public Citizen said the company should withdraw all supplies from warehouses, wholesale distributors and drug stores ``instead of choosing to sell as much of the drug as it can until the curtain drops.''

Nonetheless, Hoechst Marion Roussel stands behind the safety of Seldane, said Charles Rouse, spokesman for the Kansas City, Mo., company.

``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,'' he said.

Seldane long ago yielded the market lead to Claritin, made by Schering Plough Corp. Schering-Plough shares closed at 69-3/8, up 1 on the New York Stock Exchange. Hoechst Marion Roussel doesn't trade publicly.

The FDA said that when the cardiac risks became known, Hoechst Marion Roussel and the FDA launched educational campaigns to warn physicians, pharmacists and the public about the dangers.

``Although these efforts have reduced inappropriate prescribing and dispensing of terfenadine with other drugs, such events have not been, and almost certainly cannot be, eliminated,'' the FDA said.

Said Rouse: ``We don't think there is sufficient reason, certainly because of safety issues, to take Seldane off the market; that as long as it is taken in accordance with the (package) insert that it is safe and effective medicine.''

He said his company will campaign aggressively to keep the drug for the ``many patients who have been taking Seldane for the better part of 10 years and do fine with it.''
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Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:Business
Publication:Daily News (Los Angeles, CA)
Date:Jan 14, 1997
Words:565
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