Regulatory

Canada: may be tie between Sanofi's Ketek, liver harm

Last Updated: 2006-02-07 16:11:32 -0400 (Reuters Health)

OTTAWA (Reuters) - The federal health ministry warned Canadians on Tuesday that there might be a link between the antibiotic Ketek (telithromycin), produced by France's Sanofi-Aventis, and potentially serious liver problems.

Health Canada cited international reports of patients who had either experienced liver failure or death while using the drug but said no such cases had been reported in Canada.

"Health Canada is currently reviewing Canadian cases of less serious liver problems and other safety information for Ketek," it said in a statement.

Health Canada said it was telling doctors not to give Ketek to patients who had preexisting liver problems.

"Canadian health care professionals and patients will be advised if further precautionary measures are necessary," the statement said.

Last month, Europe's drug regulator said it had asked Sanofi-Aventis to include stronger warnings about potential liver disorders on product information for Ketek.

Three patients in North Carolina developed severe liver damage and one of them died after being treated with the drug, physicians in the United States said in January.