Could FDA End Deadly Antibiotic Drug Trials?
The antibiotic drug Ketek, manufactured by Sanofi-Aventis, is being tested to treat ear infections and tonsillitis in close to 4,000 children, ages 6 months to 13 years. Although the Food and Drug Administration (FDA) approved plans for the trials, in May 2006 an FDA official said — according to internal memos — that the trials should be halted because Ketek could be deadly. The antibiotic, approved for use in adults, appears to be more toxic than other antibiotics. Side effects range from liver failure and blurred vision to loss of consciousness. Though other antibiotics have been associated with liver failure, the condition seems to be four times as common in Ketek. In the United States, 12 adults taking Ketek have had liver failure, of which four died, and 23 had serious liver injury since the drug was approved two years ago. In the memos, FDA safety officials said the agency should consider withdrawing Ketek from the market, severely restrict its uses, or add a strong warning abo
