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KETEK LIVER FAILURE
by Jane Mundy
Ketek is an antibiotic that was once prescribed to treat sinus infections such as bronchitis, pneumonia, and acute bacterial sinusitis. Ketek is metabolized in the liver and prevents bacteria from growing by interfering with the synthesis of protein. However, in January of 2006, the FDA received several reports that linked Ketek to serious liver damage.
The FDA has now linked Ketek to several deaths and at least 53 reported cases of liver failure (some patients died after being treated for a simple sinus infection). Although the drug has already been withdrawn for the treatment of sinus infections, it is still available to patients who have a certain type of pneumonia.
Recently, the FDA has come under fire regarding its approval process that allowed Ketek on the market in the first place. Sanofi-Aventis, the maker of Ketek, has been criticized for the safety trials it commissioned regarding Ketek. Criticisms of Sanofi-Aventis include fraud, malpractice, and conflicts of interest.
The FDA has been accused by its critics of not properly protecting the safety of American consumers. They claim that the process by which Ketek was approved was filled with false data, illegal activity, and omitted information.
One doctor who participated in a Ketek safety study allegedly falsified results, a fact that FDA managers hid from an FDA panel that eventually recommended the drug. Sanofi-Aventis conducted the study whereby physicians were given up to $400 per patient enrolled in the study, which was conducted over five months. One of the physicians, who now serves a prison sentence for her actions, committed fraud by falsifying data and fabricating patient enrollment in the study.
Even though FDA managers knew about problems with the study, information claiming Ketek was safe was still presented to an FDA advisory committee. The committee voted to recommend Ketek for approval.
As well, allegations have arisen that the FDA knew that patients died after using Ketek but still did not request a new warning label for the drug until the media reported the fatalities.
Furthermore, the standard by which Ketek was approved showed only that Ketek was better than a placebo, not that it was better than, or even equal to, other drugs on the market. The FDA finally withdrew approval of Ketek for two uses, but that action was only taken one day before a Congressional hearing on Ketek began.
Although the FDA has reports of many patients who suffered serious complications after using Ketek, it is likely that there are more patients who became ill after taking Ketek but did not realize their problems were associated with the drug. Patients who take Ketek are also at risk of developing blurred vision and loss of consciousness. Patients with myasthenia gravis, a neuromuscular disease, have reported a worsening of their symptoms, including life-threatening problems breathing, when they have been treated with Ketek.
Lawsuits have been filed against Sanofi-Aventis for pushing the approval of Ketek despite allegedly knowing about the life-threatening risks.
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