To: 5,17,37,5,101,... who wrote (543 ) 2/28/1998 4:10:00 PM From: flickerful Respond to of 756
Friday February 27, 6:58 pm Eastern Time FDA warns consumers against Seldane antihistamine WASHINGTON, Feb 27 (Reuters) - The U.S. Food and Drug Administration (FDA) told consumers on Friday they would no longer be able to get the antihistamine Seldane or its generic equivalent. The drugs, which contain terfenadine, have been pulled off the market after they were linked to rare heart problems and interactions with other drugs. ''These products are officially off the market. We want to make sure than consumers who have refills know they may have problems getting them refilled now,'' an FDA spokeswoman said. In December, Seldane's makers Hoechst Marion Roussel (HOEG.F) voluntarily discontinued distribution and marketing of the drug. Baker Norton Pharmaceuticals, a subsidiary of IVAX Corp (IVX - news), also withdrew its generic version of terfenadine. ''Terfenadine-containing products will soon disappear from pharmacies as existing supplies are depleted,'' the FDA said in a statement. Terfenadine was the first of a new class of antihistamines that did not make users drowsy. The FDA said an alternative was available. ''The reason that Seldane was withdrawn from the market was that there was an alternative product approved -- that's Allegra and Allegra D (fexofenadine),'' the spokeswoman said. ''Fexofenadine provides exactly the same benefits of terfenadine, but it does not cause a potentially fatal heart condition when taken with certain other commonly prescribed medications,'' the FDA said. ''The best thing that patients should do is consult their health care provider,'' the FDA spokeswoman advised. Allegra, also made by Hoechst, got U.S. marketing clearance in July 1996. Earlier this month, the FDA and Janssen Pharmaceutica issued a warning to doctors about possible drug interactions with another antihistamine, Hismanal, known generically as astemizole. Taken at higher than recommended doses or with some drugs, Hismanal can cause irregular heart rhythms or severe allergic reaction. Janssen, a subsidiary of Johnson & Johnson (JNJ - news), is working with Sepracor Inc (SEPR - news) to develop norastemizole, which should be an improved antihistamine. ------------------------------------------------------------------------ More Quotes and News: Ivax Corp (AMEX:IVX - news)Johnson & Johnson Inc (NYSE:JNJ - news)Sepracor Inc (Nasdaq:SEPR - news) Related News Categories: health ------------------------------------------------------------------------ Help ------------------------------------------------------------------------ Copyright c 1998 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon See our Important Disclaimers and Legal Information. Questions or Comments?