Ketek Lawsuit and Side
Effect Information

Ketek lawsuits have been filed by consumers experiencing serious problems with Ketek side effects. While people have demanded it be taken off the market, the FDA has not yet removed it.

Ketek Overview

Ketek (telithromycin) was approved for use in the United States in 2004. Made by Sanofi-Aventis, its reason for creation was to treat respiratory infections. It's referred to as a ketolide antibiotic, a new class of antibiotics that also include ketolides cethromycin, spiramycin, ansamycin, oleandomycin, carbomycin and tylocine. Ketek was also the first of its class to be put to clincial use.

You may recognize the names of some of the more common macrolide antibiotics: azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac), erythromycin (EES granules) and roxithromycin (Rulid).

Drug trials for Ketek first started in France under the wing of Hoechst Marion Roussel (now Sanofi-Aventis) in 1998. The drug was approved in Europe in 2001 and then made its way to the US. Ketek's claim to fame is that it stops bacteria from growing by inhibiting the bacteria's ability to synthesize protein.

Its other not so famous claim to fame is that it can cause false positive readings on drug screenings for cocaine and amphetamines. A Ketek lawsuit would focus on liver damage.

Ketek Side Effects & Other Problems

Ketek's two major problems are how the FDA approved it in the first place, and the numerous deaths attributed to it. The story goes that despite some significant unanswered questions, and the fact that they knew some of the US trials were faked, the FDA gave the nod to allow this drug to be marketed. In point of fact, Study 3014 was fraudulent.

Study 3014 was so full of holes that when hearings were held to determine what on earth was going on, the Senate Committee overseeing the affair was appalled. One doctor participating in the trials actually went to jail for falsifying information.

Charges against the doctor included defrauding Aventis and fabricating data she sent to the company. It turns out Aventis knew there was a problem with this doctor but said nothing to the FDA. They only admitted it after the FDA found out on its own. These incidents are some of the details a lawyer would focus on in a Ketek lawsuit.

The most common Ketek side effects are upset stomach, diarrhea, nausea, stomach pains, vomiting, headaches, change in taste, black outs, fainting, palpitations, blurred vision, liver damage, fatal myasthenia gravis cases and rashes.

Despite the fact that liver damage is supposedly rare, the whole controversy over Ketek involves death from liver damage by patients taking this drug. The actual statistics for 2006 showed the FDA got reports of 35 cases of acute liver failure, serious liver injury and four deaths from taking Ketek. By 2008 the figures were looking even grimmer with 18 deaths and 134 cases of liver damage.

Keep in mind these are only the reported cases. Chances are there were other unreported cases where no one made the connection between Ketek use and liver problems. This drug is still on the market.

In 2007, rather than recall the drug, the FDA revised the label to improve patient safety. Although how reading a label will stop liver damage is difficult to comprehend.

The new label changes removed two previously approved uses: bacterial chronic bronchitis and bacterial sinusitis. Ketek was left on the market to treat community-acquired pneumonia.

The other change to the label was to add a black box warning indicating Ketek was not to be used for patients with myasthenia gravis, a disease causing muscle weakness. Just reading about this doesn't quite bring home the full extent of Ketek side effects that include fulminant hepatitis, liver necrosis leading to liver transplant or death, and aggravation of existing myasthenia gravis ending in death or respiratory failure.

In all cases of Ketek side effects that targeted the liver, the symptoms developed with frightening rapidity during or shortly after finishing the drug. Some cases were reversible, but only if there was no toxicity involved.

Lawsuits of note against Aventis have been and are for:

* Ambien/zolpidem - sleeping aid. Ambien induced sleepwalking, sleep-driving, sleep-eating and other parasomnias
* Plavix - alternative to aspirin that doubles the risks for heart attacks and strokes
* Discrimination Class Action Lawsuit - thousands of current and past workers for discrimination, sex bias
* Yposemed - patent infringement for Solo Star insulin pen
* PharmaNetics - false and misleading ads and information about Lovenox/enoxaparin sodium, an anticoagulant
* EFF/Medical Week News - battle over use of name Acomplia as relates to AcompliaReport.com site and Acomplia, an obesity and stop smoking drug
* Conneticut Attorney General - inflating drugs prices for Medicare uses

Ketek Lawsuits

There are a large number of Ketek lawsuits being prepared against Aventis. Lawyers across the US are asking that anyone harmed by Ketek side effects contact them to have their claim assessed. You may be able to file a Ketek lawsuit and be awarded damages for your suffering.




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