Telithromycin is the generic name of a drug that is marketed as Ketek. Sanofi-Aventis, French pharmaceutical giant manufactures it. It is an antibiotic used to treat respiratory infections like chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.

In the Annals of Internal Medicine Three cases of liver toxicity were reported in an article and reported to FDA MedWatch. The reports say that one patient among these three cases needed a liver transplant, one patient recovered and the third one died. Massive tissue death was seen on examination of these patients’ livers. It was reported that the patient who needed liver transplant and the one who died did use some alcohol. But all the patients were not using any other prescription drugs and were healthy before they started using Ketek.

However, this is not new in the Ketek’s track record.  In June, 2001 also, The U S Food and Drug Administration (FDA) rejected the initial new drug application for telithromycin. FDA demanded extra information about liver injuries, blurred vision, and other possible side effects regarding the drug for additional safety data. Citing these concerns, Sanofi was ordered by the FDA to conduct further safety tests. Study 3014 on October, 2001 was started by the company but it proved to be a terrible failure.

The largest number of subjects were recruited a physician who has fabricated the data. He pleaded guilty but he ended up in federal prison. The company’s concerns with its highest recruiter were not disclosed to the FDA. However, the problems were uncovered independently as The Wall Street Journal reviewed internal corporate documents. The FDA found the second-high enroller (251 patients) have not followed the protocol or reported adverse drug reactions. He accepted to never having participated in a study before in an interview with The Wall Street Journal. At the time of study the third-highest recruiter (214 patients) was working under sanction of a state disciplinary board with a provisional license. This same doctor was found at his home with a loaded handgun and cocaine in his underwear and was later arrested for threatening to kill his wife.

The point is the Study 3014 was exclusively authorized to investigate liver toxicity but the entire affair ended up as sad and most shocking. There is new evidence that Ketek is harmful to the liver after being on the market for two years. The rate of reporting of acute liver failure was 3.5 to 11 times high for Ketek than other antibiotics as is showed by the post-marketing database of the FDA. The expected rate is one case per one million person-years but 167 cases of acute liver failure per 1 million person years of telithromycin use were reported.

Now you can get immediate medical assistance if you have been affected or experienced the side effects of Ketek. You can learn more about a drug lawsuit by approaching an experienced Ketek law firm. You can get an idea whether you are eligible for monetary compensation which includes pain and suffering, medical care, future medical costs or lost wages.