Dangerous Drugs:
Ketek
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Congressional Investigation Related to Ketek Approval

January 29, 2008--As part of an ongoing congressional investigation of Sanofi-Aventis’s antiobiotic Ketek, the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigation voted to approve a motion to subpoena FDA officials and investigators over data from a pre-approval safety trial (Ketek Study 3014) of the drug which has since been linked to liver failure.

The panel is particularly interested in whether Sanofi-Aventis was aware of “substantial data integrity problems” with the study at the time of its submission to the FDA. The company has previously stated that it was not aware of the fraud in Study 3014 until after it was submitted to the FDA.

Ketek Gets FDA's Strongest Warning

February 12, 2007 -- The FDA issued a Black Box Warning for the antibiotic drug Ketek for two of the three previously approved uses -- acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. The risks of using Ketek to treat these conditions outweigh the benefits.

The warning states that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness. In addition, the FDA strengthened warnings for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances.

Previous FDA Concerns over Ketek

On June 8, 2006, Ketek clinical trials on children were halted because it was found that the drug could be deadly to children. Ketek was being tested on nearly 4,000 infants and children as a treatment for ear infections and tonsillitis. The drug, currently only used in adult treatment, has been reported to cause liver failure, blurred vision and loss of consciousness in adults. A recent FDA report cited 23 adults who suffered serious liver injury, 12 adults who suffered liver failure, and 4 adult patients who died from using Ketek.

FDA safety officials have written in their reviews that the agency should consider withdrawing Ketek from the market, restrict its uses, or add a more prominent warning label about the potentially fatal side effects.

Ketek was found to cause liver failure almost 4 times as often as other antibiotics

On January 20, 2006, researchers reported three cases of severe liver toxicity following the use of Ketek. Of these cases, one patient needed a liver transplant and another died. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek.

Ketek, known generically as telithromycin, is an antibiotic used for the treatment of respiratory infections including chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek is manufactured by Sanofi-Aventis.

Ketek is widely marketed and used in other countries, including countries in Europe and Japan . The Food and Drug Administration (FDA) approved Ketek for use in the United States in April 2004. Since then approximately 5 million prescriptions have been written.

Three cases of liver toxicity were reported to FDA MedWatch and reported in an article in the Annals of Internal Medicine. Of these cases, one patient recovered, one patient needed a liver transplant and the other died. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek and were not using other prescription drugs. The two latter patients had reported some alcohol use.

The FDA is currently examining the frequency of liver-related adverse effects of Ketek and similar antibiotics in order to determine if labeling changes or other actions are needed.

The FDA has issued the following recommendations to healthcare providers and patients:

  • Patients taking Ketek, or generic versions, should be monitored for signs of liver problems. If symptoms develop, patients should stop taking Ketek.
  • Patients who are not experiencing side-effects such as jaundice (yellowing of the skin or eyes) should not stop taking Ketek unless otherwise directed by their doctor.
  • Patients who notice warning signs of liver toxicity such as jaundice (yellowing of the skin or eyes) or blurring vision should contact their doctor immediately.
  • Ketek, like an antibiotic, should not be used to treat viral infections. This drug is only effective against susceptible microorganisms.

Current labeling warns doctors of the potential for liver-related adverse effects associated with the use of Ketek

Note - Do not change medications without first consulting your doctor.
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