Ketek recall from the market to be reviewed by FDA

Austin Kirk

By Austin Kirk
Posted November 14, 2006


NEWS UPDATE: Today the FDA announced that they will hold public advisory hearings next month regarding the antibiotic Ketek.  They will review whether there should be a Ketek recall from the market or whether other measures should be taken to protect consumers.  Since Ketek was approved in 2004, many experts have questioned the safety of Ketek following reports of liver failure and death in some users.  There have also been discoveries of fraud during the FDA approval process, raising questions over whether the antibiotic ever should have been approved in the first place.

Public hearings will be held on December 14 and 15, 2006 to review the Keteck side effects.  A panel of experts will examine the evidence and determine whether the risks of injury outweigh the benefits of the antibiotic.  The review could lead to a recommendation for a Ketek recall or for new warnings to be added to the antibiotic.  In most cases the FDA follows the recommendations of their advisory panels. 

>>INFORMATION: Ketek side effects

Ketek (telithromycin) is an antibiotic which has been approved for treatment of respiratory tract infections, chronic bronchitis, acute bacterial sinusitis and pneumonia.  It is manufacturered by Sanofi-Aventis, a large french pharmaceutical company.  In addition to answering questions about the safety of Ketek, Sanofi-Aventis has also been dealing with recent Plavix lawsuits over side effects associated with their popular blood thinner.

A U.S. Senate Finance Committee is currently investigating the FDA approval process as a result of the fraud allegations connected with the clinical trials.  Evidence has indicated that doctors falsified data and underreported adverse reactions in the trials used to obtain approval.

In June 2006, a new Ketek warning label was added to the antibiotic, indicating the increased risk of liver damage which could lead to death.  This label update was a bold warning.  However, many experts believed that it should have been a black box warning.  A Ketek black box warning would be the strongest warning which could be placed on the medication to alert consumers and physicians of the safety concerns without issuing a Ketek recall.

>>PRIOR NEWS 6/30/06: Ketek warning label for liver damage

Ketek lawsuits are being reviewed by Saiontz & Kirk for users who have suffered:

  • Liver Damage
  • Liver Failure
  • Acute Respiratory Failure
  • Death

If you, a friend or a family member have used Ketek and suffered a side effect injury, our Ketek lawyers can review your claim and determine if you may be eligible for compensation.  Request a free claim evaluation.

3 Comments • Add Your Comments

  • ira diamond says:

    I was prescribed Ketek for a sinus infection and became ill extremely nausuas after taking just one pill.

    Posted on February 26, 2007 at 12:48 pm

  • won't take again says:

    I was prescribed Ketek more than once. Each time it made my vision VERY blurry and it was hard to drive. Also it made me extremely groggy and what I would imagine “high” to the point where my boss said, “never take that medicine again.”

    Posted on April 9, 2008 at 9:24 am

  • Chris says:

    I was prescribed Ketek to treat a sinus infection in September of 2006. The dosage was to take two 400 mg tablets the first day. I don’t remember the dosage after that. What I DO remember is that early in the treatment, I had strange visual disturbances, heart palpitations and thought I was having a heart attack. I was a healthy 46 yr old female. I went to the ER, where the technician hooked me up to an EKG and laughed at me – accusing me of being the nervous worrying type (which I did not appreciate). The ER doctor assured me that it had nothing to do with Ketek and told me to lay off the caffeine.

    Posted on August 27, 2008 at 12:49 pm

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