Tuesday, December 12, 2006

Ketek (Antibiotic): Facing the Music before the FDA

The FDA first approved Ketek in April 2004 for the treatment of pneumonia, sinusitis and bronchitis. Not long after that, the Public Citizen Health Research Group, added the antibiotic to its list of "do not use" drugs. Public Citizen cited reports of liver toxicity, serious vision problems and the possibility of heart rhythm disturbances.

Later this week (Thursday and Friday) the FDA convenes a joint meeting of its Anti-Infective Drugs and its Drug Safety and Risk Management advisory committees to discuss what it calls Ketek's overall benefit-to-risk considerations. See FDA information here.

I think that the FDA will order the drug maker to strenghthen its warnings regarding the drug.

Canada has issued a warning regarding this drug:

Health Canada is advising Canadians about a possible link between use of the antibiotic Ketek and potentially serious liver problems.

There have been international reports of patients using Ketek who experienced liver failure requiring transplant or resulting in death, although no such cases have been reported in Canada. Ketek (the brand name for telithromycin), which has been marketed in Canada since May 2003, is indicated for the treatment of pneumonia, throat and sinus infections and chronic bronchitis, as well as serious or multi-drug resistant infections.