Ketek, known generically as telithromycin, is a ketolide antibiotic used for the treatment of respiratory infections including chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek is manufactured by Sanofi-Aventis.
In April 2004, the Food and Drug Administration (FDA) approved Ketek for the treatment of respiratory infections including sinusitis, bronchitis, and pneumonia after two previous application rejections in 2001 and 2003 after the agency requested more safety data.
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. Since then, a confidential FDA Ketek memo has been announced publicly; the report reveals twelve cases of liver failure including four deaths associated with Ketek. The Wall Street Journal reported about the memo, but the FDA is not releasing it to the public. New concerns have been raised about Ketek’s liver risks, and as such, the FDA is currently examining the frequency of liver-related adverse effects of Ketek and similar antibiotics. In doing so, a determination will be made whether or not labeling changes or other actions are necessary. However, the current Ketek label warns doctors of the potential for liver-related adverse effects associated with the use of the antibiotic.
In May 2006, lawmakers began to question the approval of Ketek due to reports of fraudulent data.
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.
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If you or a loved one experienced liver failure, liver damage, hepatitis, or liver toxicity while taking Ketek or after taking Ketek, contact
Jim S. Adler & Associates today. We provide a free consultation for Ketek victims and their families. Call 1-800-320-1000 or complete our online case evaluation form.
