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Learn More About Ketek Claims

 
Summary

Ketek (generic name: telithromycin) is an oral antibiotic, manufactured by Sanofi-Aventis, to target upper respiratory infections such as bacterial sinusitis, pneumonia and chronic bronchitis. In 2004, it was approved by the Food and Drug Administration (FDA) for use in adults and more than five million Ketek prescriptions have been written since then.

Calls by advocacy groups to withdraw Ketek from the market came after news of: 1/ faked clinical trial data and 2/ severe adverse side effects, including heart damage, liver failure, blurred vision, loss of consciousness and death. It has also been shown to worsen the symptoms of myasthenia gravis, an autoimmune disorder which is marked by progressive muscle weakening. If you or a loved one experienced adverse effects from Ketek use, contact a pharmaceutical attorney, personal injury lawyer, Ketek attorney, or drug effects lawyer.

According to the NY Times, Ketek was linked to four deaths, 23 liver injuries, and 14 liver failures from 2004 to 2006. In 2008, sources cite the death stats at 18, with over 100 cases of liver damage. Because many adverse drug reactions go unreported, these numbers could be higher. A personal injury attorney, Ketek lawyer, pharmaceutical lawyer, or drug effects attorney can advise you on pursuing legal action.

Sanofi-Aventis first applied for FDA approval of Ketek in February 2000. The drug was rejected twice – the first time in 2001 and again 2003 – before finally being accepted in April, 2004.   

Approval came despite information from the company's own clinical trials which linked Ketek with liver problems. Later it was found that Sanofi-Aventis’ study, using 24,000 patients, was flawed and that the company had concealed test information. One of its investigators ended up in federal prison and another lost his medical license.

A major problem with Ketek is that liver toxicity can occur even when taking normal dosages of the drug. Excess dosages can have fatal consequences.

On January 20, 2006, the FDA sent out a "Public Health Advisory" warning that some Ketek users experienced liver damage. Among its victims were: a North Carolina patient who died only days after being first prescribed Ketek; a 49-year-old woman who took no more than two doses of the antibiotic before becoming nauseous and dying five days later; a patient who needed a liver transplant; and another patient who contracted hepatitis. (Hepatitis is a gastroenterological disease known as inflammation of the liver.)

As a result of these and other serious side effects, the FDA added a "Black Box Warning" to the Ketek label.

In June of 2006, the FDA asked Sanofi-Aventis to halt an ongoing clinical trail involving the use of Ketek in children. At the time, Ketek was being tested as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children (aged six months to 13 years) in the U.S. as well as a dozen other countries.
Some medical experts argue that Ketek should never have been approved for salebecause its risks far outweigh its benefits. Call a pharmaceutical attorney if you have experienced unwanted side effects following Ketek prescription.

While other antibiotics can cause liver failure, Ketek does so nearly four times as often -- and can occur in otherwise healthy people. FDA officials estimated that Ketek caused acute liver failure in 23 out of 10 million prescriptions -- or about four times the rate of other antibiotics. If you or a loved one were injured or killed from the use of Ketek, a medical malpractice attorney, pharmaceutical lawyer, products liability attorney, or personal injury lawyer can be of great assistance in pursuing a lawsuit.

On January 25, 2008 The House Oversight and Investigations Subcommittee subpoenaed FDA investigators to ask why they ignored the warnings about Ketek in the drug’s approval process. To date, Ketek is still available on the market.

Who Can Sue

If you or a loved one has experienced adverse medical reactions – such as liver damage, heart irregularity or fainting spells -- related to the use of Ketek, you may be eligible for compensation. An experienced drug effects lawyer, personal injury attorney, pharmaceutical lawyer, or Ketek attorney can quickly review the facts of your case and tell you whether or not you have grounds for a lawsuit.

If you are currently taking Ketek and have concerns about its safety, you should consult your doctor regarding other treatment options. If you experience any worsening of your symptoms (such as muscle weakness, difficulty breathing, heart problems or jaundice) while taking Ketek, stop taking it immediately and contact your doctor.Class actions are being examined in light of the allegation that the manufacturer knew in advance of Ketek’s increased risk of liver damage but did nothing until after incidents of liver failure and death were reported to the FDA.

 

Interesting Facts

Ketek is in the ketolide class of antibiotics and was the first in this class to be approved by the FDA.

Drug reactions are one of the leading causes of death in the United States. However, less than one percent of adverse drug reactions are reported to the FDA because there is no reporting system in place once a drug goes on the market. If you experienced negative drug reactions, a pharmaceutical attorney, Ketek lawyer, or personal injury attorney can help you receive financial retribution for your resultant medical costs.

Ketek was approved in Europe in 2001. Although it is unusual for the FDA to approve a drug in the States based upon its approval elsewhere, it did just that when it approved Ketek, according to some who are critical of the investigation.

Serious Ketek side effects are:
  • jaundice (yellowing of the skin and/or eyes)
  • redness, blistering, peeling of the skin, including the skin inside the mouth
  • persistent diarrhea
  • skin rash and itching
  • swelling of tongue or throat
  • difficult breathing
  • fainting spells
  • eye problems such as blurred vision, difficulty focusing and double vision
  • vomiting

Sanofi–Aventis changed the prescribing instructions for Ketek to include warnings about liver failure after an FDA’s med alert (FDA News, June 29, 2006). The FDA also issued a public health advisory which described the link between Ketek and liver damage (Public Health Advisory, January 20, 2006).

Dr. Danny Benjamin, an infectious-disease specialist at Duke University, was consulted by the FDA during their investigation into Ketek’s infant and child clinical trials. He reported that up to 87 percent of pediatric ear infection cases are resolved within a few days without the need of an antibiotic treatment.

Congress has questioned whether the FDA relied on bad drug information to approve Ketek. At issue are: 1/ the doctor who recruited patients for Ketek studies and then was convicted of providing fake data and 2/ foreign reports issued after Ketek went on the market which impacted its approval. (Letter: Sen. Edward Markey and Rep. Henry Waxman to the FDA, May 1, 2006)

Potential Recovery

There is no information relating to Ketek legal settlements or class actions lawsuits to report at this time.

News

Telithromycin (marketed as Ketek) Information

FDA Curbs Use of Ketek

Controversial antibiotic Ketek will face more FDA scrutiny

Halt Is Urged for Trials of Antibiotic in Children

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