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Biotech / Medical : IPIC -- Ignore unavailable to you. Want to Upgrade?

To: Trey Yon who wrote (925)	12/11/1997 11:37:00 AM
From: JMarcus	Read Replies (1) \| Respond to of 1359

Check out the following article in today's Wall Street Journal: Early Warning: Heart-Valve Problem That Felled Diet Pills Had Arisen Previously --- U.S. Sellers Heard Reports From Belgium but Passed Only Some On to FDA --- Redux Panel Was in the Dark ---- According to the article, "[w]hen seven Belgian patients unexpectedly developed leaky heart valves, a cardiologist named Mariane Ewalenko asked them what medications they were taking. In each case, the answer was the same: diet pills. "The Belgian doctor says she informed the French company that made the drugs. She also gave a talk on the subject to several dozen obesity specialists at a conference in Brussels. 'This is very suspicious,' she told the doctors. 'Listen carefully to your patients for heart murmurs.' "That was in February 1994. It was, in other words, more than 3 1/2 years before the same two drugs were pulled from the U.S. market amid suddenly surging fears about pills that had become hugely popular among overweight Americans. "In all, various Belgian doctors reported at least 30 cases of heart-valve problems in diet-pill users between 1994 and 1996, according to the doctors themselves and to records at the United Nations' World Health Organization. Some reports were made to Belgian drug regulators and some to the European supplier, Laboratoires Servier SA. WHO keeps a database that is available to national health agencies." According to the article, Servier claims to have informed American Home of the Belgian heart-valve cases in a timely manner. American Home admits that Servier told them of 25 Belgian cases and six others elsewhere in Europe and claims to have passed 10 of the 31 reports on to the FDA, which confirms receipt of 8. At least 7 of the 25 Belgian heart-valve reports involved Redux. Of those 7 patients, 4 took Redux alone and 3 took it in a fen-phen combination. IPIC says it gave FDA a detailed report on at least one Belgian case involving Redux in an amendment to its NDA.