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Biotech / Medical : Oscient Pharmaceuticals Corp. (OSCI) -- Ignore unavailable to you. Want to Upgrade?

To: fred hayes who wrote (1125)	1/21/2006 1:02:11 AM
From: fred hayes	Read Replies (1) \| Respond to of 1154

Ya, but no rash... ---------------------------------------- Sanofi Antibiotic May Be Tied To Liver Problems, Doctors Say By JENNIFER CORBETT DOOREN DOW JONES NEWSWIRES January 21, 2006; Page A6 Doctors at Carolinas Medical Center in Charlotte, N.C., on Friday said one patient died from liver failure and another required a liver transplant in cases that might be linked to an antibiotic marketed by Sanofi-Aventis SA, of France. Doctors also said one patient developed drug-induced hepatitis but recovered. The antibiotic is sold under the brand name Ketek and was approved by the Food and Drug Administration on April 1, 2004. The three case reports were released Friday in an online edition of edition of the Annals of Internal Medicine1. The article describing the liver problems will appear in the March 21 print edition. See the FDA's advisory2 for Sanofi-Aventis antibiotic Ketek."These cases could represent an unusual clustering of a rare, idiosyncratic drug reaction at one medical center," said John Hanson, one of the article's authors and hepatologist with the liver-transplant center at Carolinas Medical Center. "However, the severity of liver injury in two of our patients warrants this report in the medical literature and will alert other physicians to this possible link with telithromycin," which Ketek is known as generically. All of the cases have been reported to the FDA. Susan Bro, an agency spokeswoman, said the FDA is reviewing the reports and conducting a review of other reported adverse events related to Ketek. She said, for now, that the FDA isn't making any new recommendations regarding the prescribing practices for Ketek. She said patients shouldn't stop the medication, but should contact their physician if they notice yellowing of their eyes or skin or other problems such as blurry vision. (See the FDA health advisory.3) "At this time, FDA advises health-care providers to monitor patients taking telithromycin (Ketek) for symptoms of possible liver problems including jaundice or elevated liver enzymes," the agency said in a statement. The drug's label, which is aimed at physicians, discusses the possibility of liver dysfunction. Rare liver problems have been seen with Ketek and similar antibiotics. A Sanofi spokesman didn't return calls for comment. The three cases of liver problems involved patients who weren't on other medications, but two of the three reported regular alcohol use. Researchers said there is no proof that Ketek caused the liver problems but that "caution is advised in prescribing this drug pending additional postmarketing surveillance data." Dr. Hanson said, despite the three reports, that there is "not enough data to indicate major changes in prescribing habits." According to the article, 10 reports of liver problems had been reported to the FDA involving Ketek as of June. However, researchers said in eight of those cases patients were also on other medications. Ketek was approved to kill bacteria that cause sinus infections, bronchitis and pneumonia. It is in a group of medicine known as macrolides, which include erythromycin, Pfizer Inc.'s Zithromax and Abbott Laboratories' Biaxin. The drug's label said cases of liver problems had been reported but that they were "generally reversible." The label warns of possible vision problems. Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com4