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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (251)	6/8/1998 2:33:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

[Roche] Heart Drug Pulled From Market JUNE 08, 09:51 EDT By LAURAN NEERGAARD AP Medical Writer WASHINGTON (AP) - Roche Laboratories pulled its new heart drug Posicor off the market worldwide today because it causes potentially dangerous interactions with more than 25 other medications, from antihistamines to antibiotics. The hundreds of thousands of patients now taking Posicor for high blood pressure or chronic angina, a type of chest pain, should not just stop taking the pills on their own, the Food and Drug Administration warned. Stopping medications can be risky, so the FDA urged patients to promptly call their doctors about getting an alternative therapy - and until they get a new treatment, they should not begin taking any additional drug without a doctor's specific OK. Switching to a new medicine should be easy, because Posicor does not offer any unique protection against hypertension or angina, FDA officials stressed. ''There are plenty of other choices available,'' said drug chief Dr. Murray Lumpkin. About 400,000 people worldwide take Posicor, including almost 200,000 Americans, Roche estimated. The drug had been sold in about 38 countries. The FDA approved Posicor last June, and it began selling in August. The FDA knew at the time that it could interact with three other drugs - many medicines do cause such interactions - and followed the standard procedure of placing a warning on Posicor's label so doctors wouldn't prescribe it to patients taking those other drugs. But by December, the FDA was warning doctors not to prescribe Posicor to patients taking an entire class of cholesterol-lowering drugs, or to patients with low heart rates, after receiving about 20 reports of serious side effects. The list of potentially dangerous interactions continued to grow, as the FDA accumulated several dozen reports of serious side effects, including some fatalities, possibly linked to Posicor interacting with other medications. The FDA said Posicor doesn't offer patients any advantage over similar blood pressure medicines known as calcium-channel blockers. And Posicor is mostly taken by older people who require many medicines for diverse health problems, so simply warning doctors not to allow such interactions was fast becoming unfeasible, Lumpkin said. The final straw came a few weeks ago, when a study that Roche was hoping would show Posicor helped patients with congestive heart failure instead failed. Roche agreed to pull Posicor off the market. Posicor, known chemically as mibefradil, is a chemically unique calcium-channel blocker that significantly interferes with the liver's metabolism of medicines. While many medicines do inhibit liver function, Posicor proved to be an extremely powerful liver inhibitor, allowing other medicines to accumulate in the body to dangerous levels, said FDA's Dr. Robert Temple. Roche established a hot line - 1-800-205-4611, from 8 a.m. to 8 p.m. EDT - to answer physician and patient questions. The company also will reimburse U.S. patients for any Posicor they already have bought but do not consume, and those patients should call the hot line to get reimbursement information, said company spokeswoman Valerie Suga. The company also is writing thousands of doctors, pharmacists and other health care workers today to explain the problem.

To: Anthony Wong who wrote (251)	6/8/1998 5:51:00 PM
From: Anthony Wong	Respond to of 1722

Warner-Lambert rebounds as Rezulin concerns ease Monday June 8, 4:04 pm Eastern Time NEW YORK, June 8 (Reuters) - Shares of Warner-Lambert Co. (WLA - news) jumped Monday, rebounding from losses suffered Friday after the National Institutes of Health discontinued tests of the company's drug Rezulin for prevention of type 2 diabetes. Shares were up 3-3/16 to 65-1/2 in afternoon trade, more than offsetting Friday's decline of 1-11/16. Mike Krensavage, a drug analyst for Brown Brothers Harriman, said Friday's downturn was an overreaction to the NIH move to discontinue the Rezulin prevention trial. ''But today we're seeing a recovery'' from that sell-off, he added. Rezulin (troglitazone) was launched by Warner-Lambert in early 1997 for treatment of type 2 diabetes and quickly became a big seller, helping lift Warner-Lambert's valuation. It has never been approved for the prevention of diabetes, although the NIH was testing the drug to determine whether or not it would prevent or delay type 2 diabetes in people with impaired glucose tolerance, a possible precursor to diabetes. The NIH on Friday said it stopped the prevention trial after one person taking Rezulin developed liver failure. But the agency said its action did not affect people taking Rezulin for treatment of their diabetes. Krensavage said the Friday sell-off was unwarranted because, although future Rezulin sales would surely benefit if the drug were ever approved for prevention, its currently authorized therapeutic use was unaffected by the NIH action. Bear, Stearns & Co. drug analyst Scott Shevick also believed the Friday sell-off was excessive. ''People are realizing now that kind of decline was not deserved,'' he said. Concern about the drug's safety was roused in December when the U.S. Food and Drug Administration told doctors to monitor patients taking Rezulin after some people using the drug suffered liver failure and three died. About two percent of patients taking the drug show an elevation of certain liver enzymes in the blood, a possible indication of liver damage, Warner-Lambert has said. Glaxo Wellcome Plc (quote from Yahoo! UK & Ireland: GLXO.L), which sold troglitazone in Britain under the name Romoxin, suspended sales in December because of the reported adverse drug reactions in the United States. But the London-based company said last month that it was planning to discuss with Britain's Medicines Control Agency possible reintroduction of the drug, which it licensed from the drug's developer Sankyo Co. Ltd. (4501.T). biz.yahoo.com