Hepatotoxicity Risks Noted In September 2006 "Dear Doctor" Letter
On October 4, 2006 Health Canada issued a MedEffect alert to let doctors and patients know that the drug company Sanofi-aventis Canada is updating its safety information on Ketek (telithromycin).
As had been reported previously, some patients taking Ketek have experienced serious liver problems during or following their use of this relatively new antibiotic. Since Ketek came on the market in 2003, cases of severe liver injury, some resulting in death, have been reported to Health Canada and to the FDA.
According to a September 29, 2006 "Dear Doctor" letter concerning Ketek sent by the drug company:
Based on information in published case reports [i.e., "Brief communication: severe hepatotoxicity of telithromycin: three case reports and literature review", K.D. Clay et al. (2006) Ann Intern Med 144:415-20] and post-market adverse event reports, the Canadian Product Monograph has been revised to include information on severe and sometimes fatal hepatotoxicity in patients taking KETEK.
Acute liver failure including fulminant hepatitis and hepatic necrosis leading to liver transplant or death have been observed during or immediately after the completion of KETEK treatment.
....Most post-marketing cases of hepatic dysfunction were reversible after discontinuation of KETEK, however cases of severe hepatotoxicity, including necrosis, hepatic failure and death have occurred. In some of these cases liver injury occurred after administration of only a few doses of KETEK and progressed rapidly. The mechanism underlying severe hepatocellular injury is unknown. Severe reactions, in some but not all cases, have been associated with serious underlying diseases or concomitant medications.
In its October 4, 2006 MedEffect Public Advisory concerning Ketek Health Canada cautioned that if you experience any signs or symptoms of serious liver problems, "you should not take your next dose of KETEK, and either call your doctor immediately, or go to a clinic."
The signs or symptoms of hepatitis, liver disease, and liver failure include:
- nausea;
- fatigue;
- malaise;
- loss of appetite;
- light-colored stools;
- dark-colored urine;
- generalized itching or abdominal pain; and,
- jaundice (yellow color to the skin and/or eyes).
(Posted by: Tom Lamb)