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Did you know that the Food and Drug Administration (FDA) has ordered pharmaceuticals manufacturer Sanofi-Aventis to put more strident side effects warning on the packaging of Ketek (telithromycin), an antibiotic that has been linked to incidents of liver toxicity, liver failure, and death. The drug, Ketek has been prescribed over five million times since it received FDA approval in April 2004. This order follows a public health advisory issued by the FDA, which recommended that health care providers monitor Ketek patients for side effects, including jaundice, blurry vision, and other symptoms of liver disease.

Ketek Side Effects and Dangers

It is important that you know that Sanofi-Aventis' initial application for Ketek's FDA approval was initially rejected in 2001 and again in 2003, but was ultimately accepted for treatment of a host of respiratory conditions, including pneumonia, bronchitis, and sinus ailments. However, claims of Ketek side effects are quickly casting a shadow over the successful drug's future. The drug has been implicated for multiple side effects, most of which affect liver function. In January 2006, Annals of Internal Medicine reported that liver toxicity had affected three Ketek patients, one of whom required a liver transplant, one of whom recovered -- and one of whom died.

An internal memo has cited 12 cases of acute liver failure and up to four deaths, and more than 20 other cases of severe liver damage have been reported. There have been other reports of Ketek side effects, and experts note that only between one and ten percent of side effects are ever reported to the FDA. Though liver damage is the most critically dangerous of the Ketek side effects -- one patient developed the liver failure that ultimately led to his death after taking the drug for only five days -- the drug has also been linked to worsening of the neuromuscular condition myasthenia gravis, an autoimmune disorder that causes progressive muscle weakening.

A Questionable Approval Process on the Drug Ketek

Did you know that questions have also surrounded the clinical trial and approval process for the drug Ketek. It has now been confirmed that an Alabama Doctor submitted false clinical information to the drug's Phase III study and was convicted of mail fraud after being charged with falsifying clinical data in the drug's comparative study. Aventis failed to disclose the study's known integrity problems when it submitted the drug's clinical trial results to the FDA. This flawed approval process and recent evidence of adverse Ketek side effects has led to a Congressional investigation on the FDA process behind the popular drug.

Senator Grassley is heading up the Congressional investigation, which is attempting to understand the extent of the FDA's complicity with Ketek's manufacturer (the FDA is now accused of continuing to cite and rely upon the false clinical data from the fraudulent study).

If You've Been Affected

If you have experienced or suffered a Ketek side effect or injury, get immediate medical assistance and call our Law Firm day or night. Our Law Firm will work for you and will help you assess your potential claim and advise you whether you may be eligible for monetary compensation covering medical care, future medical costs, lost wages, or pain and suffering. Call our Law Firm today.  You deserve to be fairly compensated for the life-threatening side effects of this antibiotic.  Call us toll free at 1-800-862-1260.

TRADEMARK NOTICE: Ketek is a trademark of Sanofi-Aventis, Inc.

The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Sanofi-Aventis, Inc. The use of this mark is solely for informational and product identification purposes.