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FDA is pulling popular allergy medicine off market
January 13, 1997
Web posted at: 9:30 p.m. ESTFrom Correspondent Jeff Levine
WASHINGTON (CNN) -- Federal regulators are moving to take a popular allergy medicine, Seldane, off store shelves after findings that it can cause a potentially fatal heart condition when combined with certain other drugs.
The FDA said it intends to withdraw its approval of Seldane and Seldane D antihistamine and generic versions, all of which contain terfenadine.
Millions of people have used Seldane, which was the first drug to relieve allergy symptoms without inducing drowsiness.
The Food and Drug Administration warned in 1992 that taking Seldane with certain other drugs could cause an irregular heartbeat, which can be fatal. Educational campaigns, including labeling changes and warning statements, have reduced but not eliminated the problem, the FDA said.
Hoechst Marion Roussel of Kansas City, which markets the drug, defended Seldane's safety when used properly. The company has 30 days to challenge the FDA's decision.
The company also announced a promotional campaign Monday to switch patients from Seldane to Allegra, another allergy treatment approved by the FDA last summer. It has been available in drugstores since August.
Researchers say Allegra has all the benefits of Seldane, without posing a threat to the heart. It contains a different ingredient, fexofenadine, which does not cause the same dangerous interactions, the FDA said.
"If Seldane is helping you, then Allegra will also help you, because Allegra is the active ingredient that your body turns Seldane into," said Dr. Martha White of the Washington Hospital Center.
Seldane's U.S. sales in 1995 were $400 million, down from a peak of $600 million earlier.
Reuters contributed to this report.
Related sites:
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- Food and Drug Administration (FDA)
- Hoechst Marion Roussel Committed to Education Regarding Seldane Usage
- Allegra New Non-Sedating Antihistamine Now Available
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