Thursday, September 20, 2007

Ketek Lawyer :: Ketek Attorney

On June 29, 2006, the U.S. Food and Drug Administration ordered the makers of Ketek to put a stronger warning on the drug labels because of its link to serious side effects including liver injury, liver failure and death. The FDA has 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 also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic, also called telithromycin.

The FDA had rejected the drug in 2001 and 2003, asking for more safety information.
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 approved Ketek in April 2004, the drug's labeling included precautions about 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 is the first FDA-approved antibiotic of the ketolide class, and the FDA has concluded that the drugs’ benefit to patients for the approved indications outweighs its risk. Following an internal FDA memo reporting that Ketek has been linked to 12 cases of liver failure and 4 deaths, 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, Ketek drug trials on children were widely criticized, even from a few members of Congress. The drug had only been approved to treat mild to moderate respiratory infections in adults.

People who qualify for Ketek lawsuits must have suffered a severe liver injury. Severe liver injuries include: liver failure, drug-induced hepatitis requiring hospitalization, liver damage which requires a liver transplantation, and death.

Ketek (Telithromycin) 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 by Ketek, it is important that you contact a Ketek lawyer before your statute of limitations expires. Get the information you need here, and then let us know how we can help you.

You may use this section to find out more about the antibiotic Ketek, Ketek's dangerous side effects, and what you need to do to file a Ketek lawsuit.