Search:

Home |


Ketek Allegedly Linked to Liver Failure Among Patients

By:

Ketek, also telithromycin, is an antibiotic that is used to treat bacterial infections. However, the U.S. Food and Drug Administration (FDA) recently increased the warning labels on the medication because of a strong link to liver toxicity among patients.

The drug has been prescribed over five million times since it received FDA approval in April 2004. This order follows a public health advisory issued by the FDA in January 2006, which recommended that health care providers monitor Ketek patients for side effects, including jaundice, blurry vision, and other symptoms of liver disease.

Dangerous Ketek Side Effects

Sanofi-Aventis' application for Ketek's FDA approval was rejected in 2001 and again in 2003, but was ultimately accepted for treatment of a host of respiratory conditions, including pneumonia, bronchitis, and sinus ailments. However, claims of Ketek side effects are quickly casting a shadow over the successful drug's future.

The drug has been implicated for multiple side effects, most of which affect liver function. According to a study published in the Annals of Internal Medicine found that patients who consumed Ketek needed liver transplants and one of which who died. An internal FDA memo has cited 12 cases of acute liver failure and up to four deaths, and more than 20 other cases of severe liver damage have been reported.

There have been other reports of Ketek side effects, and experts note that only between one and ten percent of side effects are ever reported to the FDA.

It has been reported that one patient who had taken the drug for only five days developed liver failure that caused him to die.

Faulty Approval Process?

The development as well as approval process and clinical trials have been under extreme questioning by individuals. An Alabama doctor submitted false clinical information to the drug's Phase III study and was convicted of mail fraud after being charged with falsifying clinical data in the drug's comparative study.

Aventis failed to disclose the study's known integrity problems when it submitted the drug's clinical trial results to the FDA. A Congressional investigation is underway to uncover the details as to how the FDA approves medicine including Ketek.

Senator Charles Grassley of Iowa is heading up the Congressional investigation, which is attempting to understand the extent of the FDA's complicity with Ketek's manufacturer (the FDA is now accused of continuing to cite and rely upon the false clinical data from the fraudulent study).

If You've Been Affected

If you have experienced Ketek side effects, get immediate medical assistance. Also, locate an experienced Ketek law firm to learn more about a drug lawsuit. Your Ketek attorney will help you assess your potential claim and tell you whether you may be eligible for monetary compensation covering medical care, future medical costs, lost wages, or pain and suffering. A Ketek lawyer can help you file your lawsuit and be fairly compensated for the life-threatening side effects of this antibiotic.

Copyright (c) 2008 Katie Kelley

Article Source: http://articlescrub.com

LegalView's Ketek portal (ketek.legalview.com) has details of the medical device and side effects. Or visit www.LegalVIew.com and learn about other recalled medical topics such as the Viapro recall or the Cipro class action lawsuit.

Please Rate this Article

 

Not yet Rated

Click the XML Icon Above to Receive Articles Via RSS!
Additional Articles From - Home |
Sign Up for a FREE ACCOUNT
Submit Articles
Member Login
Top Authors
Most Popular Articles
Submission Guidelines
Article RSS Feeds
Link to Us
Contact Us
Privacy Policy
Terms of Service
ARTICLESCRUB.com » Copyright © 2007
Terms of Service | Submission Guidelines | Contact Us | Link to Us| Privacy Policy | About Us

Powered by Article Dashboard