Ketek Drug Alert Information Center: __________________ Bronchitis Drug - Ketek - May Cause Liver Failure Information and Warnings about the drug Ketek Ketek Side Effects and Dangers Liver Failure, Liver Damage and Hepatitis Drug Alert - Ketek Ketek Drug Alert Update The Facts about Ketek

The FDA has ordered the makers and marketers of the prescription drug Ketek, to put additional warning on the drug labels in light of the discovery of new medical links of the drug Ketek to serious side effects.  These side effects include but are not limited to liver injury, liver damage, liver failure and death.

The FDA issued this alert in part for it received reports of 12 cases of acute liver failure, including four deaths, in patients treated with Ketek, according to an internal agency memo. FDA safety evaluators have also uncovered 23 other cases where patients who have suffered serious liver injuries after receiving the antibiotic, also called telithromycin.

The FDA had initially rejected the drug in 2001 and 2003, asking for more safety information.  The drug Ketek is most frequently prescribed for patients with chronic bronchitis; acute bacterial sinusitis; and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. When the FDA did approve the drug Ketek in April 2004, the drug's labeling included precautions about potential liver injury and possible worsening of myasthenia gravis, as with other drugs in its class. Sanofi Adventis is now revising the drug labeling to address the new concerns about Ketek’s potentially fatal impact.

Ketek's new label will also note that there have been reports of fatal worsening of the neuromuscular condition, myasthenia gravis. The FDA knows of three reported deaths in myasthenia gravis patients taking Ketek. These deaths occurred separately from the reported liver problems.

The drug Ketek is the first FDA-approved antibiotic of the ketolide class, and the FDA has concluded that the Ketek drugs’ benefit to patients for the approved indications outweighs its potential risk to the user. Following an internal FDA memo reporting that Ketek has been linked to 12 cases of liver failure and 4 deaths, the French Drug Manufacturer Sanofi-Aventis confirmed on May 19 that it was in discussion with the USDA about its antibiotic Ketek after the USDA wanted a warning label put on the drug.

Recently, the Ketek Drug Trials on children were widely criticized, even from a members of the United States Congress. Ketek had only been approved to treat mild to moderate respiratory infections in adults.

People who qualify for an award under a Ketek Lawsuit must have suffered a personal injury, this injury may include injuries to liver or SJS or other injuries. Severe liver injuries include: liver failure, drug-induced hepatitis requiring hospitalization, liver damage which requires a liver transplantation, and death.

Ketek has many side effects associated with its use.   The most severe Ketek side effect is liver failure, which may require a liver transplant. So far, liver failure has lead to the death of 4 Ketek users. More common and less severe Ketek side-effects are gastrointestinal; diarrhea, nausea, abdominal pain and vomiting. Headache and disturbances in taste also occur. Less common side-effects include palpitations, blurred vision and rashes.

If you've been hurt, injured or suffered a loss as a result of Ketek, it is important that you contact our Law Firm before your statute of limitations expires. Get the information you need to know, call us today. Call us day or night at 1-800-862-1260