Ketek Side Effects (generic name – telithromycin)

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What is Ketek?

Ketek is an antibiotic used for the treatment of serious and drug resistant bacterial infections. Ketek was approved by the U.S. Food and Drug Administration (FDA) in April 2004 and is manufactured by Sanofi-Aventis.

What you should be aware of:

Since its approval in 2004, Ketek has proven controversial. In June 2006, the risk of liver damage was added to the label and in February 2007 the approved uses were reduced. The drug has undergone two FDA reviews and a senate investigation. Ketek is now approved only for community-acquired pneumonia in patients 18 years of age and older. Previously, the drug was also approved for the treatment of pneumonia, chronic bronchitis and sinusitis.

The FDA made the decision to limit the uses of Ketek because the benefits do not out weigh the risks. The label change in February 2007 also strengthened warnings for the risk of liver damage, loss of consciousness and visual disturbances. The warning includes that no one with myasthenia gravis (a chronic condition that causes muscles to tire and weaken easily) should take Ketek.

Prior to the approval of Ketek, the FDA was aware of potential liver problems but believed they were similar to other marketed antibiotics. Yet in January 2006, Annals of Internal Medicine published an article reporting on three patients with serious liver toxicity. One patient recovered, one patient had to undergo a liver transplant and the third patient died as a result. When the livers of the latter two patients were examined in the laboratory, massive tissue death was found.

All three patients were reported as not taking any other medications. The patients in the report were also only on the drug for a few days after symptoms of acute hepatitis occurred and all had jaundice and abnormal results on liver function tests. All three cases were reported to the FDA.

PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING THE USE OF KETEK OR ANY OTHER PRESCRIPTION DRUGS.

Contact the Law Offices of d'Oliveria & Associates, P.C.

If you or a loved one has been injured due to the use of Ketek, you need a Ketek attorney familiar with new developments in the investigation of Ketek to help you make important personal and legal decisions, and if needed to file a lawsuit. Contact us now to get the help you deserve.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.

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Questions and Answers on Ketek (telithromycin) from the FDA Website