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FDA Announces Label and Indication Changes for Antibitotic Ketek
The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications -- acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis -- from the drug's label. The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities).
read the full announcement
FDA Public Health Advisory
On January 20, 2006, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory in which the FDA warned about the use of Ketek® and potential liver toxicity. The FDA’s action was in response to an article that appeared in the Annals of Internal Medicine in January, 2006. In the Advisory, the FDA stated:
- Healthcare providers should monitor patients taking telithromycin (Ketek®) for signs or symptoms of liver problems. Telithromycin (Ketek®) should be stopped in patients who develop signs or symptoms of liver problems.
- Patients who have been prescribed telithromycin (Ketek®) and are not experiencing side effects such as jaundice should continue taking their medicine as prescribed unless otherwise directed by their healthcare provider.
- Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately.
- As with all antibiotics, telithromycin (Ketek®) should only be used for infections caused by a susceptible microorganism. Telithromycin (Ketek®) is not effective in treating viral infections, so a patient with a viral infection should not receive telithromycin (Ketek®) since they would be exposed to the risk of side effects without any benefit.
The full text of the FDA Public Health Advisory is found at: http://www.fda.gov/cder/drug/advisory/telithromycin.htm.
If you or a loved one developed liver disease or failure, or symptoms of liver failure, during or after treatment with Ketek®, please click HERE for information about your potential legal rights.
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