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FDA Orders Changes to Ketek but Leaves It on the Market

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Rockville, MDThe U.S. Food and Drug Administration (FDA) is making changes to the labeling of Ketek following pressure from numerous organizations regarding the drugs' safety. The organization has announced that Ketek will now come with a black box warning to alert consumers to the potential for serious side effects associated with taking the drug.

Furthermore, Ketek will not be used to treat sinusitis and bronchitis even though it had been approved for such uses. However, despite changes to the drugs' labeling it remains to be seen whether or not the organization has actually learned anything from its Ketek experience.

The warning label for Ketek has been upgraded to a black box warning, the most serious warning that the Food and Drug Administration can require drug makers to use. The black box warning alerts customers to the serious side effects of Ketek including liver failure, vision problems, and loss of consciousness. The black box warning also states that Ketek should not be used in patients who have myasthenia gravis which is a neuromuscular autoimmune disease that can cause life-threatening weakness in the muscles. Ketek can worsen the condition of patients with myasthenia gravis.

The recent moves by the FDA follow the recommendations that two advisory committees made last year. According to an article in the New York Times, a federal advisory panel voted 16 to 3 to allow Ketek to be used for mild to moderate pneumonia. However, the advisory panel said that even in situations of mild to moderate pneumonia Ketek should only be an alternative to other medications. The advisory panel voted 17 to 2 that Ketek should not be used for patients with sinusitis or bronchitis, two uses that Ketek had previously been approved for.

According to the New York Times article, only two of the 12 people who developed liver failure while taking Ketek were being treated for a serious illness. Nine deaths have been linked to the use of Ketek. Furthermore, since Ketek was approved for use in 2004 there have been hundreds of reports of liver damage and other serious side effects.

Despite the use of the black box warning, some critics are arguing that the black box is simply a way for the FDA to detract attention from calls to pull Ketek from the market entirely. They say that Ketek should be completely withdrawn from the market and the black box warning is the FDA's way of avoiding recalling the drug.

Serious concerns about Ketek arose in January 2006, after an online article was posted showing that three patients in a hospital in North Carolina suffered liver damage after taking Ketek. Of the three patients, one died, one required a liver transplant, and one developed drug-induced hepatitis.

In Europe, the European Medicines Agency recommended that Ketek should not be given to patients who have a history of liver conditions including hepatitis or jaundice. The agency also asked Ketek's manufacturer to put a stronger warning on the drug. In February 2006, Health Canada also issued a warning about the use of Ketek and announced that the agency was reviewing Canadian cases of liver problems associated with Ketek.

The FDA has come under fire for how it treated doctors who had concerns about the safety of Ketek. Last week the chief of the FDA said that agency whistle-blowers had the right to alert Congress to their concerns about the safety of drugs. The statement comes in the wake of concerns that the agency retaliates against employees who air their concerns about drug safety, including concerns about Vioxx and Ketek. An article in the Washington Post notes that at hearings a month ago, former FDA staff members testified that they were forced to leave the FDA out of fear of retaliation from their supervisors. One scientist said that FDA supervisors forced him to retract his findings that Ketek was likely too dangerous to be used to treat bronchitis and sinusitis.

Ketek, known generically as telithromycin, is manufactured by Sanofi-Aventis. It was approved by the FDA in April 2004, following multiple applications in which the FDA rejected the drug pending further evaluation.


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