Sanofi-Aventis SA today, told U.S. regulators that its Ketek antibiotic is an essential treatment for bacterial infections, although the drug has been linked to liver failure and death in some patients.
Two Food and Drug Administration committees are hosting public meetings over the next two days to discuss whether Ketek, used to fight pneumonia, bronchitis and sinusitis, is safe enough to remain in place on the market. Over 600 cases of liver damage, loss of consciousness and several other side effects have been reported since the drug won U.S. approval in April 2004.
“There’s no question that there’s some rare risk” to the liver, Judith Jones, an adjunct professor of pharmacology at Georgetown School of Medicine in Washington, told the panels today on behalf of Sanofi. “This has been known since prior to approval and has been confirmed. What we need to focus on is what the current question is, and that is, in comparison to what?”
Sanofi, France’s biggest drugmaker, urged regulators to consider studies that show their drug has similar risks as other drugs used for the same indications such as clarithromycin, sold as Abbott Laboratories’ Biaxin XL, or as a generic. Reports of adverse events may be skewed by opinion and differences in how data is compiled.
Sanofi agreed in June to bolster U.S. prescribing information by including a bold-faced warning about the risk of potentially fatal liver damage. A European Medicines Agency panel said last month that Ketek shouldn’t be given to patients with a history of liver conditions such as hepatitis or jaundice.
Regulators identified 79 reports of liver damage linked to the drug as of April, including four reports of death in the U.S. according to documents. Approximately 390 patients had reported blurred vision and other impairments as of July 7 and 137 patients had some loss of consciousness while taking the drug.
All data will be reviewed by the 11 doctors and scientists on the FDA’s panel to review drug safety and anti-infective medicines, along with eight consultants to the agency’s Center for Drug Evaluation and Research at a meeting in Silver Spring, Maryland. Usually the agency follows advertiser’s recommendations, although not required to do so.