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KETEK RISKS OUTWEIGH BENEFITS
by Jane Mundy
The antibiotic Ketek was approved by the FDA in 2004, despite the agency first rejecting it. Since its approval, many cases of liver failure and at least four deaths have been linked to the antibiotic.
By the end of 2006, an FDA advisory committee determined that the antibiotic should not be used to treat bronchitis and sinusitis because the risks of the drug outweighed its benefits for those conditions. Ketek was eventually given a black box warning, and approval remained for the treatment of community-acquired pneumonia.
Sanofi-Aventis, the manufacturer of Ketek, applied for FDA approval back in February 2000 but information from the company's own clinical trials indicated that the antibiotic could be associated with liver problems. The FDA required more information from the company; the manufacturer initiated a fraudulent study involving 24,000 patients, sending one of Ketek's clinical investigators to prison for 57 months.
In July, 2006 Dr. David Graham, an official with the FDA's safety office, said approval of the drug was a "mistake" and contended that "every principle concerning the review and approval of new drugs was abandoned or suspended where [Ketek] is concerned." Almost two years later, David Ross resigned his position as FDA scientist, mainly due to the agency approving Ketek, despite his findings. Ross determined that Ketek caused dangerous side effects and recommended it stay off the market.
Congress got involved back in May 2006, around the same time that the Government Accounting Office (GAO) released a report suggesting the FDA cannot adequately monitor drug safety after launch and protect US citizens from harm. In June 2008, it asked questions about whether FDA officials quashed a field agent's calls for a full investigation into Ketek.
The controversy over the manufacturer's fraudulent trial data for Ketek (telithromycin) is ongoing. In May 2008 a Ketek clinical investigator who was involved in two studies of the antibiotic received a warning letter: apparently he enrolled ineligible subjects and allowed them to take prohibited medications in conjunction with Ketek, improperly kept the study drug in an unlocked cabinet, retroactively modified study records with undated handwritten notes, failed to report adverse events and failed to get proper informed consent.
In addition to liver problems, reports associated with Ketek include blurred vision and loss of consciousness, and the drug has also been linked with a severe risk to individuals with myasthenia gravis, a neuromuscular disease.
More than six million Ketek prescriptions have been written by US doctors but many experts and regulators believe that the risk of liver problems may not be worth Ketek's limited benefits.
If you or someone you know has taken Ketek and developed any of the above symptoms, contact a doctor immediately. You should also consider contacting a Ketek attorney who will review your case at no charge.
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