Ketek Facts:

Severe liver damage (hepatoxicity), in some cases leading to liver transplant or death, has been reported in patients treated with the antibiotic Ketek. Three cases of liver toxicity in patients taking Ketek antibiotic were reported to FDA MedWatch and reported in an article in the Annals of Internal Medicine. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek and were not using other prescription drugs. The two latter patients had reported some alcohol use.

These instances of acute hepatic failure and severe liver injury were observed either during, even after only a few doses, or immediately after treatment. In addition, less severe hepatic dysfunction associated with increased liver enzymes, hepatitis and in some cases jaundice was reported with the use of Ketek. These events associated with less severe forms of liver toxicity were reversible.

The most common side-effects of Ketek 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. Patients using Ketek should be aware of the potential signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria (presence of bile in urine), acholic (pale or clay-colored) stools, liver tenderness or hepatomegaly (enlargement).

Ketek antibiotic has also been found to exacerbate Myasthenia Gravis, an autoimmune disorder that causes progressive muscle weakening. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis and its use in such patients is therefore contraindicated.

Usage:

Ketek, known generically as telithromycin, is an antibiotic used for the treatment of respiratory infections including chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek is manufactured by the French pharmaceutical giant Sanofi-Aventis. Telithromycin is administered as tablets. Two 400mg tablets to be taken together, daily, with or without food. It prevents bacteria growth, by interfering with its protein synthesis.

Litigation:

A Congressional investigation is attempting to determine why the drug was approved even after a physician was convicted of fraud in clinical trials of Ketek. The initial new drug application for telithromycin was rejected by the FDA in June, 2001, citing a request for additional safety data regarding liver injuries, blurred vision, and other possible side effects. Based on these concerns, the FDA ordered Sanofi to conduct further safety tests.

The FDA uncovered some problems with Sanofi's Study 3014 with have resulted in the imprisonment of the lead subject ruecruiting physician, who recruited 414 subjects, at $400 each according to the contract introduced in evidence at her trial. She is now in federal prison after pleading guilty to fraud resulting from the fabrication of data.

Internal corporate documents reviewed by The Wall Street Journal indicate the company's concern with its highest recruiter, but the concerns were not disclosed to the FDA. The second-high enroller (251 patients) was found during an FDA audit to have not followed the protocol or reported adverse drug reactions. The third-highest recruiter (214 patients) was, at the time, working with a probationary license under sanction of a state disciplinary board; the FDA audit found evidence of records altered with "white-out."

What is perhaps most outrageous about the entire sad affair is that Study 3014 was specifically mandated to investigate liver toxicity. Now, after being on the market for two years, there is new evidence that Ketek is harmful to the liver. A recent analysis of the FDA's post-marketing database showed that the rate of reporting of acute liver failure was 3.5 to 11 times as high for Ketek as for other antibiotics, with a reporting rate of 167 cases of acute liver failure per 1 million person years of telithromycin use, as compared with the expected rate of 1 case per 1 million person-years.

If you or a loved one developed liver failure or any other side effects as a result of using Ketek, please fill out the short form to the right for a free and confidential consultation with a DrugSettlement.com attorney or representative about your potential case.

If you or a member of your family may have been injured as a result of a pharmaceutical drug, please contact the defective drug lawyers at the Law Office of Nix and McIntyre.

We serve clients nationwide, in Alabama (Montgomery), Alaska (Juneau), Arizona (Phoenix), Arkansas (Little Rock), California (Los Angeles, San Diego, San Francisco), Colorado (Denver), Connecticut (Hartford), Delaware (Dover), Florida (Jacksonville, Miami), Georgia (Atlanta), Hawaii (Honolulu), Idaho (Boise), Illinois (Chicago), Indiana (Indianapolis), Iowa (Des Moines), Kansas (Topeka), Kentucky (Frankfort), Louisiana (New Orleans), Maine (Augusta), Maryland (Baltimore), Massachusetts (Boston), Michigan (Detroit) Minnesota (Minneapolis), Mississippi (Jackson), Missouri (St. Louis, Kansas City), Montana (Helena), Nebraska (Lincoln), Nevada (Las Vegas), New Hampshire (Concord), New Jersey (Trenton), New Mexico (Santa Fe), New York (New York City), North Carolina (Charlotte), North Dakota (Bismarck), Ohio (Columbus, Cleveland), Oklahoma (Oklahoma City), Oregon (Portland), Pennsylvania (Philadelphia), Rhode Island (Providence), South Carolina (Columbia), South Dakota (Pierre), Tennessee (Memphis, Nashville), Texas (Dallas, Houston) Utah (Salt Lake City), Vermont (Montpelier), Washington (Seattle), Washington D.C., West Virginia (Charleston), Wisconsin (Madison) and Wyoming (Cheyenne) and their surrounding areas.