Initiating Ketek Litigation
May 21, 2008 09:18

Anyone who performs even a modicum of Ketec research will discover that this antibiotic has brought about a number of lawsuits. These instances of Ketec litigation derive from various product liability lawsuits. This is an unfortunate occurrence as much of... (Read Article)

FDA approved antibiotic drug - Telithromycin
May 5, 2008 14:56

Telithromycin is an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by Sanofi Aventis under the brand name Ketek. Telithromycin was U.S. approved in April 2004.

Telithromycin is indicated for the treatment of bacterial infections such as community-acquired pneumonia, acute bacterial sinusitis, and acute bacterial exacerbation of chronic bronchitis.

A report in the Annals of Internal Medicine explains that three patients had jaundice and abnormal liver function after taking telithromycin (Ketek). One patient recovered, one required a transplant, and one died. All three patients had previously been healthy.

At the time of market approval for telithromycin (ketek), the product label included a precautionary statement advising doctors that hepatic adverse event (hepatic dysfunction, increased liver enzymes and hepatitis, with or without jaundice) had been reported and that these events were generally reversible. This precaution was based upon the findings from the phase three clinical studies and post-marketing data from other countries.

Patients who have been prescribed telithromycin and who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare providers. 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.

Telithromycin is marketed and used extensively in many other countries, including Japan and European countries. The FDA is working with regulatory authorities in these other countries to obtain further information on reports of liver problems associated with the use of telithromycin.

While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

If you or a loved one is the victim of telithromycin liver damage, please contact us about a possible lawsuit. Find out what your legal options are.

The Bush administration has declined to comply with a congressional subpoena for documents related to Sanofi-Aventis' antibiotic Ketek.
February 15, 2008 10:36

An investigative subcommittee of the House Energy and Commerce Committee sought papers used to prepare Food and Drug Administration Commissioner Andrew von Eschenbach for testimony he gave at a hearing on the drug last March. The administration's response was released yesterday by the panel.

Suits Over Antibiotic Ketek Bolstered By House Inquiry Into Faulty Testing
February 15, 2008 06:14

New Jersey Law Journal reports that Plaintiffs in New Jersey and six other states who claim the antibiotic Ketek caused liver disease are getting a booster shot from a congressional inquiry into the clinical trials that led to FDA approval. On Tuesday, witnesses at a hearing before the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations testified that Ketek's trials were flawed and that the company had knowledge of flawed data even before FDA approval.

Ketek: Who can you trust?
June 14, 2007 11:41

Source: http://www.sptimes.com/2007/05/31/Opinion/Yet_more_suffer_as_FD.shtml Dozens of people have suffered liver disease and five have died because the Food and Drug Administration (FDA) ignored serious fraud concerns to approve a new antibiotic for sinus... (Read Article)

Sinus Sufferers: Do Not Take Ketek
June 1, 2007 11:42

Source: http://www.nbc5.com/health/13361549/detail.html

Two North Carolina patients took Ketek for sinus infections. One died and the other needed a liver transplant. What's wrong with this picture?

Ketek is a relatively new antibiotic drug prescribed for sinus infections and bronchitis.

It's a scandal picture painted by the drug manufacturer in France to the U.S. Congress, where senators like Iowa's Charles Grassley were shocked at how the drug got FDA approval in the first place.
Grassley's sub-committee heard testimony that one of the doctors used in the drug's safety study had falsified results, and that FDA managers hid that fact from the FDA panel that recommended the drug. Then the FDA muddled the problem by using unscientific foreign reports of Ketek's side effects to claim it was safe.

When cases of death and injury began to appear, the testimony alleges the FDA did not issue an adequate new warning label for at least a year.

In the United States, Ketek is still on the market, but not for coughs and sniffles anymore -- only for a type of pneumonia.

A Sanofi-Aventis spokesperson said they are committed to patient safety and only learned of the fraudulent behavior of one of their investigators when the FDA discovered it. Meanwhile the FDA said it tossed out that study but approved Ketek based on foreign data on side effects and other smaller drug studies.

Prescription drug buyers beware; what does it take to get bad drugs recalled?