Ketek Dangers, Liver Disease, and the FDA

Ketek Dangers, Liver Disease, and the FDA

Whose side is the FDA on anyway? Ketek is not the first drug where the FDA put the drug companies profit before public health and safety. Internal emails have surfaced about how the FDA pushed the antibiotic drug Ketek despite urgent warnings from its senior drug safety scientists.

Ketek was approved under suspicious circumstances. A key clinical trial for the drug, involving 24,000 patients, was found to be fraudulent, according to FDA investigators. One document concluded that Sanofi-Aventis hid safety dangers from the FDA. Yet the drug was approved anyway, and the FDA now cites a known fraudulent study to defend the drug and argue against its withdrawal.

In January 2006, the Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity after using Ketek (telithromycin). The FDA was aware of these three reports described in the Annals of Internal Medicine and those reports were already part of the FDA’s ongoing assessment of liver toxicities. The article did not prompt the initiation of a new safety assessment. But what the article did do was prompt the FDA to issue a Public Health Advisory (PHA) which provided recommendations to the health care providers and patients while the FDA was continuing its investigation of the issue.

Knowing the risks for liver disease and hepatitis, the FDA had only asked doctors to monitor patients taking Ketek for symptoms of liver problems and to immediately discontinue treatment if the side effects arose.

Finally on June 29, 2006 the FDA approved a labeling supplement submitted by Sanofi-Aventis as a “Changes Being Effected” (CBE) supplement, which highlights the WARNINGS section of the labeling to raise attention to the risk of liver toxicity associated with Ketek and strengthen the WARNINGS for patients with myasthenia gravis. It also provides enhanced safety information for health practitioners and patients.

As for Ketek, the FDA continues to believe that the benefits of the drug outweigh the risks when used appropriately and that the benefit/risk profile for Ketek is similar to that of other approved antibiotic drugs used to treat the same types of infections. The FDA will continue to monitor reports of adverse events with Ketek and will take appropriate additional regulatory actions if new information leads to a different conclusion about Ketek’s benefit/risk profile.

According to the FDA, patients who have been prescribed telithromycin and are not suffering side effects such as jaundice should continue taking their medicine as prescribed. Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare providers.

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