When did the FDA know that Ketek Caused liver damage?

On February 12, 2007 the Food and Drug Administration (FDA) announced a label change for Ketek , the controversial antibiotic. According to a press release that day, Ketek was banned for use sinusitis and bronchitis, though it was still available on the market for pneumonia. New labeling also warns doctors and patients that severe liver damage can occur even after just a few doses.

The problem is that the FDA knew about these problems long before February 12, 2007. Internal documents showed that Dr. David Graham, a 20-year veteran at the FDA and part of the safety office, urged senior officials to remove Ketek from the market altogether. In an e-mail dated June 16, 2006, Dr. Graham questioned why Ketek was on the market at all since the agency didn't even know if the drug worked. "...we’re flying blind as far as safety goes, except for our own data that suggests [Ketek] is uniquely more toxic than most other drugs.”

Others within the FDA shared the same view, including Dr. Charles Cooper, Dr. David Ross, and Dr. Rosemary Johann-Liang. Two weeks after the internal e-mail, the FDA changed the labeling to note that Ketek could cause serious liver injury, liver failure, or even death.

But the story about Ketek's troubles start long before this. In 2000, years before the FDA finally approved Ketek, there were already signs within Sanofi-Aventis's own research that the drug caused liver problems. Further, the clinical trials seemed to have problems that the company was aware of, but did not discuss with the FDA until the agency found out on its own. Among the issues was serious allegations of fraud – one doctor was given prison sentence of almost five years in connection to her fraudulent Ketek trial research.

Although Ketek was rejected in 2001 and 2003, for some reason the FDA did approve it for sale in the U.S. in 2004. Many are baffled as to why, including scientists inside the FDA like those mentioned above. By one account, Ketek has caused fourteen cases of liver failure, four of which ended in death. Twenty-three other cases of severe liver injury have been reported, and there are also reports of blurred vision and loss of consciousness. All this for an antibiotic that most researchers don't believe is any better than anything else on the market.

The day after the FDA changed the labeling for Ketek, a House Subcommittee convened to review the FDA's drug approval policies, including the process it took to approve Ketek.

The fact that the FDA is being reviewed at all should be some cause for concern to doctors and consumers alike. However, ultimately it is the drug companies themselves that are responsible for the safety of their products. If you or a loved one has experienced serious side effects while taking Ketek, contact a Jim S. Adler & Associates personal injury attorney today to find out your legal options. We can provide you with a free case review to outline your possible courses of action, and we may be able to secure the compensation you deserve for your injuries. Call us directly right now, or fill out the free case evaluation form on this page with the details of your Ketek liver damage injury.