FDA scientist questions the use of antibiotic Ketek
An FDA staff drug reviewer has openly criticized the continued use of the antibiotic Ketek in a letter to the New England Journal of Medicine published on November 23, 2006. Ketek side effects have included liver failure and death which the manufacturer did not adequately warn users about.
The FDA scientist, Dr. David Graham, wrote that the agency’s decision to approve Ketek in 2004 was made without reliable data disproving the earlier safety concerns expressed by a 2001 advisory committee which recommended against approval. Overseas data was used to gain approval instead of requiring the company to obtain new studies. Since the antibiotic has been on the market, there has been an alarming rate of liver failure and death among users. This has led to serious concerns in the medical and legal community about the FDA approval process and whether further steps should have been taken to protect consumers.
Rates of Ketek liver failure were cited as being 3.5 to 11 times higher than with other antibiotics used to treat the similar conditions. Dr. Graham wrote:
“Given that (Ketek) is neither clinically superior to other drugs prescribed for respiratory tract infections nor uniquely life saving, physicians, patients and third party payors might wish to reconsider their choice of antibiotics for such infections.”
>>RELATED POST (11/14/06): FDA to consider Ketek Recall
The product liability lawyers at Saiontz & Kirk will be closely monitoring the upcoming FDA hearings where they may consider a possible Ketek recall. For the last six months, we have been reviewing potential Ketek lawsuits for users who have suffered liver damage, liver failure or death. If you, a friend or family member believe you may have a case, request a free claim evaluation.
