FDA Public Health Advisory and Ketek (telithromycin)

KETEK (Telithromycin) is an FDA approved antibiotic drug , which belongs to the ketolide class, marketed in the U.S. by Aventis. Telithromycin was approved in the U.S. in April 2004. Ketek (telithromycin) is indicated for the treatment of very serious bacterial infections, such as community-acquired pneumonia (including multi-drug resistant Streptococcus pneumoniae), acute bacterial sinusitis, and acute exacerbation of chronic bronchitis.

The FDAs MedWatch program received reports of the three serious adverse events following administration of telithromycin that were published in the Annals of Internal Medicine.  FDA has also received other reports of liver-related adverse events in patients taking telithromycin. Some of these reports were difficult to interpret because they involved patients already taking other medicines or patients with other medical conditions that might cause liver problems. In pre-marketing clinical studies, including a large safety trial, the occurrence of liver problems was infrequent and usually reversible.

Potential for Hepatic Toxicity in patients treated with Ketek

Based on the pre-marketing clinical data it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics. FDA looked extensively at the potential for hepatic toxicity in patients treated with Ketek. Data was examined from clinical studies, as well as information in nearly 4 million postmarketing prescriptions outside the United States. Ketek was the subject of two advisory committee meetings with input from a national expert on drug-induced liver disease. The committee concluded at that time that the risk for hepatotoxicity from Ketek was similar to Augmentin and erythromycin which are other approved antibiotics.  However, recent revelations indicate that its manufacturer, Aventis, withheld from or misrepresented to the FDA required information that was material and relevant to the performance of the product and was causally related to the claimant's injury.

Patients may Notice Yellowing of their Eyes or Skin, Blurry Vision

Patients who have been prescribed telithromycin and are not suffering side effects such as jaundice should continue taking their medicine as prescribed until they consult their physician regarding the risks and benefits of continuing this therapy.  Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare providers immediately. Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. Telithromycin should be stopped in patients who develop signs or symptoms of liver problems . As with all antibiotics, telithromycin should only be used for infections by a susceptible microorganism; telithromycin is not effective on viral infections, so a patient with a viral infection who took telithromycin would be taking a risk without any benefit. Contact us now to discuss your potential claim.

Ketek (telithromycin) :FDA Health Care Advisory

Audience: Infectious Disease, Hepatology and other healthcare professionals
[Posted 01/20/2006]

Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin. - January 20, 2006 Public Health Advisory FDA

In most states today, an injured person does not have to be the purchaser of the product in order to recover from the manufacturer or seller of the product under a product liability theory.

Contact Baily and Galyen for help - Its Free !

When the safe use of a consumer product including Drugs results in a personal injury or wrongful death, you have the legal right to seek compensation for lost wages, medical bills, long-term care and punitive damages. At Bailey & Galyen, our Dallas / Houston product liability attorneys are skilled at the through investigation of a negligent accident and the identification of all liable parties that helped cause the injury through design flaws, deceptive marketing or negligence.

We represent clients across the country injured by a defective consumer product:

Tire Blowout - Car Seat - Seat Belt - Crashworthiness - SUV Rollover - Appliances - Power Tools - Workplace Equipment - Dangerous Drugs - Toxic Exposure - KETEK (Telithromycin) - Fosamax - Ortho Evra

Contact Bailey & Galyen at one of our multiple offices in Texas, Florida and Missouri immediately after an injury to preserve the evidence and protect your legal rights. The first consultation with our lawyers is always FREE and there are NO FEES until we recover the maximum settlement for your injuries.