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this pageFDA To Once Again Consider the Dangers of Ketek®
WASHINGTON, DC — December 1, 2006 — The Food and Drug Administration has scheduled a two–day advisory panel meeting this month to review the safety of the antibiotic Ketek® (telithromycin), which can cause severe liver damage. Since Ketek® was approved in 2004, at least 23 patients taking the drug developed serious liver problems and fourteen had liver failures, including four patients who died as a result (NY Times, June 29, 2006).
Ketek® is used to treat community acquired pneumonia as well as bronchitis and sinus problems caused by bacteria. Besides liver damage, other Ketek® side effects include eye problems, headaches, nausea, dizziness, vomiting and diarrhea. Ketek® use also worsens myasthenia gravis, a disease in which the immune system attacks the muscles and nerves.
The panel will reconsider Ketek®’s risks and benefits. It could recommend adding further warnings to the Ketek® prescribing instructions, or even decide that Ketek® should be withdrawn from the market. The FDA often follows the suggestions of its advisory panel, although it is not required to do so.
The History of Ketek®
In January of this year, the FDA issued a health advisory about the link between liver problems and Ketek®. It later followed up in June with a press release about monitoring for liver failure in patients using Ketek®. Sanofi–Aventis, Ketek®’s manufacturer, then changed the prescribing instructions to provide a bold–face warning about liver failures.
Some members of Congress have questioned whether the FDA relied on bad data to approve the sale of Ketek® in the first place. They pointed out that a doctor who recruited patients for Ketek® studies was convicted for providing fake data. They also charged that the agency relied on foreign reports that were issued after the drug went on the market. These allegations have come before the Senate Finance Committee. Senate Finance Committee Chairman Charles Grassley (R–IA) is now challenging George Bush’s nomination of Andrew von Eschenbach as acting FDA commissioner, claiming that the nominee refused to hand over reports about allegedly falsified or inaccurate FDA data concerning Ketek® (San Diego Union–Tribune, November 18, 2006).
Finding Out About Ketek® and Your Legal Rights
Members of the public may attend the advisory meeting about Ketek®, which will be held on December 14 and 15 in Silver Springs, MD. You can find details on the FDA web site.
If you have been injured by Ketek®, please feel free to contact us for legal information. We will review your case free of charge and advise you of your legal options. At Brayton Purcell, we have been handling medical/legal cases for over 20 years and are proud of our success in protecting the legal rights of our clients.