The Food and Drug Administration announced Thursday that it will add warnings to the label of the antibiotic Ketek to reflect the chance of severe liver problems developing in users. Several deaths have been reported as a result of patients taking Ketek which is sometimes also known as telithromycin.
The antibiotic is produced by Sanofi-Aventis and was approved in 2004. It is used to treat infections in the respiratory tract, bronchitis, sinusitis and community-acquired pneumonia. The FDA still believes that the benefits of Ketek outweigh its risks.
As of April of this year, the FDA has received a dozen reports of liver failure from patients taking Ketek. Four of the patients died and a fifth required a liver transplant. Two reports of liver failure have taken place since April although the details of those two cases were not yet available.
'In certain of these cases, it appears there are no other likely causes of liver injury, so it does appear they were linked to the use of the drug,' admitted Dr. John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.
Thus far, the rate of liver problems associated with Ketek reported to the FDA is 23 per 10 million prescriptions filled. The FDA indicated this was a higher rate than similar antibiotics.
Ironically, the Senate Finance Committee is presently investigating allegations of fraud associated with trials of Ketek and how the FDA has handled safety issues associated with this particular medication.
Senator Charles Grassley (R-Iowa), the chairman of the Senate Finance Committee, released a statement saying, 'There are questions about whether this drug should stay on the market, and there's great legitimacy to those questions. Ketek is another example where the FDA accommodated a drug maker and turned a blind eye to serious safety concerns.'
Domestic sales of Ketek were an estimated $50 million in the first half of 2006 according to Sanofi-Aventis.
Further investigations as to the safety of Ketek are expected in the near future.
