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KETEK ANTIBIOTICS
by Jane Mundy
The prescription antibiotic drug Ketek (known generically as telithromycin) has been used to treat bacterial infections in the sinuses and lungs, including chronic bronchitis and pneumonia.
Manufactured by Sanofi-Aventis Pharmaceuticals, Ketek has been linked to hepatitis, liver damage and disease, liver failure and even death. On February 12, 2007, as a consequence of many reports -- over a period of several years -- linking Ketek to these adverse side effects, the drug was given a black box warning (the strongest warning) and the drug maker was told to issue a medication guide for patients. This black box warning recommendation came after FDA safety reviewers found that Ketek was linked to 12 cases of liver failure, including four deaths, in the U.S.
The Food and Drug Administration also removed from Ketek's label approval for use in treating acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, citing that "the balance of benefits and risks no longer support approval of the drug for these indications." Ketek is now approved only for the treatment of mild to moderate cases of pneumonia acquired outside hospitals or long-term care facilities.
Earlier Warnings Were Disregarded
In December of 2006, an FDA advisory panel recommended that Ketek be given a black box warning and that Sanofi-Aventis prepare a medication guide for patients who are prescribed Ketek in the future. This panel also concluded that the drug should only be used to treat community-acquired pneumonia and not chronic bronchitis or acute bacterial sinusitis. However, recommendations from this advisory panel are not binding; consequently Ketek was prescribed more than 5.6 times in the US alone since its approval in 2004.
On May 19, 2006, The Wall Street Journal published an article that included a confidential memo by the FDA's Division of Drug Risk Evaluation dated May 16, 2006 which stated an identifiable link between Ketek and liver failure. The memo also stated that from April 2004 through April of 2006, at least 23 patients suffered serious liver injury, including 12 liver failures cases, as well as 44 patients who experienced less severe liver problems. It went on to say that patients experienced liver problems within a few days after taking the drug.
Even before this article was published, the Annals of Internal Medicine reported in January 2006 three cases of liver problems, including one death, involving Ketek.
In April, 2007, the New England Journal of Medicine accused the FDA of approving Ketek "entirely on the basis of noninferiority trials". It stated that the agency's approval of Ketek was a process "marked by fraudulent data, use of uncontrolled safety reports, and reliance on improperly conducted trials". Despite this, the FDA stood by its decision to approve Ketek.
Currently, U.S. authorities are conducting an investigation of the antibiotic.
If you have taken Ketek, contact your doctor immediately if you have developed any of the following:
- liver damage;
- jaundice, drowsiness;
- dizziness;
- blurred vision or double vision;
- nausea.
- any other liver and/or kidney related health problems, particularly if you have any prior history of liver disease or kidney dysfunction.
Any symptoms of liver damage should not be ignored.
If you develop symptoms, or you have lost a loved one who was taking this drug, you may want to contact a Ketek attorney who will review your case at no charge.
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