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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Poet who wrote (3356)	6/9/1998 12:11:00 AM
From: Tunica Albuginea	Read Replies (1) \| Respond to of 9523

Leslie Mc Grath, pronto, per your wishes: only the facts My my my luki this: a great company, Roche of Switzeland, with a great pedigree, yeeears of experience, I guess messed up on one minor detail: they did not check the multiple potential interactions between Posicor and 25 other drugs that these arteriosclerotic patients were taking. Woww. And, listen to this, these patients I don't think were even caught in a physically strenuous to the CV system act: sex. So were do we go from here? Well, if I were a PFE stockholder, which I currently am not,gg, I would be asking my self: a) did PFE check the Viagra interaction with these 25 drugs? b) If yes, where is the data? Big KNY 3 to the rescue: where is the data Big K? TA biz.yahoo.com Monday June 8, 8:49 pm Eastern Time Roche withdraws Posicor heart drug WASHINGTON, June 8 (Reuters) - The heart drug Posicor has been withdrawn from the market because of dangerous interactions with other drugs, the U.S. Food and Drug Administration (FDA) said on Monday. It said Roche Laboratories of Nutley, New Jersey had voluntarily withdrawn Posicor because it interacts badly with so many other drugs -- at least 25. The FDA's statement followed an announcement from Roche AG's offices in Basel, Switzerland early on Monday that it was voluntarily withdrawing Posicor and advising physicians to propose alternative therapies to their patients. Long-term clinical trials also found Posicor was no more effective than a placebo in treating congestive heart failure, Roche AG said in its statement. ''FDA and Roche agreed that it would be difficult to administer Posicor safely,'' the FDA said in a statement. The drug, known generically as mibefradil and available in 38 countries, is a member of a class known as calcium-channel blockers. But it acts differently from other drugs in the same class. The FDA said people already taking the drug on prescription should not stop taking Posicor, but should consult their doctors soon and should not start taking any new drugs. Posicor, approved only last summer, is prescribed for high blood pressure and chronic stable angina. ''Posicor reduces the activity of certain liver enzymes that are important in helping the body eliminate many other drugs,'' the FDA said in a statement. ''Inhibiting some of these enzymes can cause some of these other drugs to accumulate in the body to dangerous levels.'' The FDA said it and Roche knew Posicor could have this effect on some drugs -- astemizole, cisapride and terfenadine -- and they labelled it accordingly, and also warned doctors. Still, there were several adverse reactions so they strenghtened the warnings. ''From spontaneous reports and ongoing trials, FDA and Roche have continued to learn of adverse reactions related to co-administration of Posicor with several other drugs,'' the FDA said. ''At present, more than 25 drugs are known to be potentially dangerous if used with Posicor -- a number and diversity of drugs that cannot be practically addressed by label warnings.'' The interactions include extremely low heart rates and a potentially threatening muscle injury that can make patients feel weak and light-headed. ''We have had some reports of deaths but the caveat (warning) with this is always that patients taking these kinds of drugs are cardiac patients, with conditions such as angina, which is very dangerous, so it is difficult to establish cause and effect,'' an FDA spokeswoman said. Posicor has no unique benefits, so the company and the FDA agreed it was best to just take it off the market and tell doctors. Here is a list of drugs that can interact in a dangerous way with Posicor. The generic name follows the brand name in parentheses: Cordarone (amiodarone) Hismanal (astemizole) Vesture (bepridil) Propulsid (cisapride) Neoral or Sandimmune (cyclosporine) Cytoxan (cyclophasphamide) Norpramin (desipramine) Erythrocin, Ilosone, etc (erythromycin VePesid (etoposide) Tambocor (flecainide) Eulexin (flutamide) Halfan (halofantrine) Ifex (ifosfamide) Tofranil (imipramine) Mevacor (lovastatin) Mexitil (mexiletine) Orap (pimozide) Rythmol (propafenone) Cardioquin, Quinidex etc (quinidine) Zocor (simvastatin) Prograf (tacrolimus) Nolvadex, tamoxifen (tamoxifen) Seldane (terfenadine) Mellaril (thioridazine) Velban (vinblastine) Oncovin (vincristine) TA

To: Poet who wrote (3356)	6/9/1998 12:20:00 AM
From: Tunica Albuginea	Respond to of 9523

Les;ie Mc Grath more facts ( and questions , gg ) . Message 4778135 Monday June 8 8:19 PM EDT Withdrawn drug dangerous with Viagra By NEAL AUGENSTEIN WASHINGTON, June 8 (UPI) - The maker of the just-withdrawn heart drug Posicor tells United Press International that the drug's interaction with the impotence pill Viagra could be dangerous, and a spokeswoman wonders why the Food and Drug Administration is not noting the link publicly. The spokeswoman for Roche Laboratories says the company ''was very upfront with the FDA'' about the Viagra-Posicor danger before announcing the withdrawal, but an FDA spokesperson could not explain why Viagra was not on its list of drugs to be avoided in conjunction with Posicor. The Nutley, N.J., company says it knows of more than 25 drugs that are potentially dangerous if used with Posicor, generically known as mibefradil. The company announced its voluntary withdrawal of the drug today. The spokeswoman tells UPI, ''Viagra would be one of the drugs that could have an interaction with Posicor,'' but Viagra or its generic name, sildenafil citrate, does not appear on the FDA's list. FDA spokeswoman Susan Cruzan could not explain why the agency did not include the drug in its list. However, she says the FDA is not aware of any people who have suffered adverse effects from mixing the two drugs. The FDA statement noted Posicor reduces the activity of liver enzymes that are important in helping the body eliminate other drugs. Inhibiting these enzymes can cause other drugs to accumulate to dangerous levels. Pfizer, Inc., the maker of Viagra, had no comment on whether any of the six men who recently died while taking the impotence pill were also taking Posicor. The spokeswoman repeated the company's statement that taking Viagra with medicines containing nitrates was dangerous. Pfizer has stated that three of the men who died suffered from cardiovascular episodes, and three died from interactions with heart medicines. Roche is warning patients who have been taking Posicor to avoid simply discontinuing treatment, because stopping medications can be risky. Patients are advised to contact their doctors about other forms of treatment. Questions about the withdrawal of Posicor can be addressed to Roche's 24-hour hot line at 1-800-205-4611. TA , AKA Lieut. Columbo, NYPD. ( Note:Lt.Columbo is now retiring for the night. He'll be back at his usual beat tomorrow ).