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Ketek Associated with Severe Liver Damage and Death

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We’d like to alert you to recent developments concerning Ketek, a popular antibiotic marketed by Sanofi-Aventis SA. Ketek has been associated with severe liver damage and death. In April 2004, Ketek was approved for upper respiratory infections in patients 18 years and older. The FDA had rejected the drug in 2001 and 2003, asking for more safety information. Although Sanofi’s clinical studies were so outrageously flawed and fraudulent as to be useless, the FDA relied on the drug’s safety record in Europe and Japan, where it had been approved since 2001, to approve the drug for sale in the United States. The Senate Finance Committee is now conducting an investigation into the FDA’s approval, and Sen. Charles Grassley, Chairman, told the Wall Street Journal, “The Ketek allegations appear to be as serious as anything I’ve seen so far.” On June 29, 2006, the FDA issued a safety alert concerning Ketek’s association with serious liver injury, liver failure and 4 reported deaths, and announced new safety information to be added to Ketek’s label.

In light of concerns that Ketek may be up to four times more toxic than other antibiotics, the FDA called for the halt of a clinical trial of Ketek in nearly 4,000 infants and children, in which it was being studied for ear infections and tonsillitis, in spite of its having caused liver failure, blurred vision, and loss of consciousness in adults. One of the lead investigators of a key clinical trial is now in federal prison after pleading guilty to fraud charges.

FDA had previously published a January 20, 2006 Safety Information Alert, citing liver problems, including three cases of serious liver toxicity (one recovered, one had a liver transplant, one died). All three patients had previously been healthy.

More than 5 million prescriptions have been written in the U.S. since Ketek’s approval on 4/1/04. According to IMS Health, 3.5 million prescriptions were written in the U.S. in 2005, with sales of $193 million.