Ketek
The antibiotic Ketek, used to treat bacterial sinusitis, pneumonia, and chronic bronchitis, has a questionable history. The drug, submitted to the FDA in 2001 and again in 2003, was denied approval each time with a request for further details regarding its safety.
A Ketek physician was convicted of submitting fraudulent clinical information to the FDA during the drug’s pre-approval trials, but this was not discovered until after Ketek’s approval in 2004. The FDA then released information detailing 12 cases of liver failure, 20 cases of liver damage, and 4 deaths associated with Ketek usage, and insisted a warning label be placed on the product.
Ketek’s blemished history and serious side effects have led to a Congressional investigation into the FDA’s approval process for the drug. The FDA is accused of continuing to cite and rely upon false clinical data from the falsified study. The FDA has responded by recommending that health care providers monitor Ketek patients for side effects, but has not been swayed to pull Ketek from the market at this time.
Based on Ketek’s tumultuous past, you may deserve compensation if you have experienced life threatening side effects associated with the drug. Please seek a Ketek attorney to discuss your options.
The dangerous drug lawyer team at Michael J. O'Connor & Associates is ready to begin tackling your legal problem today. Email or call our toll free number at 1.800.518.4LAW for a free initial consultation and review of your case.