Ketek, an antibiotic formerly used to treat respiratory infections including chronic bronchitis, sinusitis, and pneumonia and other serious or drug-resistant infections, was on the market for a little more 18 months before a report, published online by the Annals of Internal Medicine (March 21, 2006 print version) provided new Ketek information linking the use of this antibiotic to severe liver damage. Three patients in the Carolinas Medical Center in Charlotte, North Carolina suffered serious liver damage after taking Ketek. One patient died of liver failure, one required a liver transplant, and one contracted drug-induced hepatitis.
The FDA (Food and Drug Administration) MedWatch Alert The EMEA (European Medicines Agency) recommended stronger warning from the manufacturer, Sanofi-Aventis, regarding liver damage. Health Canada recommended that both patients and health care providers watch for possible symptoms of liver damage while the patient is taking Ketek.
On January 26, 2006 a consumer advocacy group called Public Citizen released a statement claiming that in the FDA had reports of at least 54 incidents of liver problems and evidence of a risk of heart, liver, and eye toxicity before the FDA approved Ketek for use in the U.S. market in April 2004. Public Citizen stated that the reports of liver damage came from countries that had permitted the sale of Ketek before FDA approval. Of the 54 reports, 19 cases of liver damage were categorized as serious.
In 2007, the FDA required a label change for Ketek and withdrew approval for the use of Ketek to treat bronchitis and sinusitis. Sanofi-Aventis made the changes in March 2007.
A few months after label changes were required a Senate subcommittee started to investigate charges that Ketek was approved by the FDA on the basis of fraudulent studies. The Health and Human Services Secretary and his records have been subpoenaed.
Consult your health care provider about the use of Ketek and the possibility of Ketek side effects before you consider taking it. If you have experienced liver problems after taking Ketek you may be entitled to recover damages for the injury you have suffered. No Ketek lawsuits have been reported, but Ketek side effects are being monitored.
Check out the following articles for more information about Ketek, filing a Ketek lawsuit and finding a Ketek attorney.
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