The United States 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 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 in January 2006, which recommended that health care providers monitor Ketek patients for side effects, including jaundice, blurry vision, and other symptoms of liver disease.

Dangerous Ketek Side Effects

Sanofi-Aventis' application for Ketek's FDA approval was 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 FDA 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.

Faulty Approval Process?

Questions have also surrounded the clinical trial and approval process for Ketek. 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 Charles Grassley of Iowa 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 Ketek side effects, get immediate medical assistance. Then contact a lawyer experienced in unsafe drugs litigation. Your Ketek attorney will help you assess your potential claim and tell you whether you may be eligible for monetary compensation covering medical care, future medical costs, lost wages, or pain and suffering. A Ketek lawyer can help you file your lawsuit and be fairly compensated for the life-threatening side effects of this antibiotic.