A U.S. Food and Drug Administration official last month called for a halt in clinical trials of an antibiotic for children because the drug could be deadly, according to internal memorandums from the
July 7, 2006 (Press Release) --
A U.S. Food and Drug Administration official last month called for a halt in clinical trials of an antibiotic for children because the drug could be deadly, according to internal memorandums from the agency.
The drug, Ketek, made by Sanofi-Aventis, is currently approved only for use in adults as a treatment for sinusitis, bronchitis and pneumonia. The company is testing the drug as treatment for ear infections and tonsillitis in almost 4,000 infants and children in more than a dozen countries, including the United States, The New York Times reported Thursday.
According to a recent review by FDA safety officials, there is growing evidence that Ketek is unusually toxic -- 12 adult patients in the United States have suffered liver failure, including four who died; 23 others suffered serious liver injury. Other antibiotics cause liver failure, but Ketek seems to do so almost four times as often, the officials concluded in the review, the newspaper reported.
"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the FDA's Office of Drug Safety at the agency, wrote in one of the memorandums obtained by the Times. Other safety officials wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects, the paper said.
FDA spokeswoman, Susan Bro, asked about the Johann-Liang memorandum, said that it was "a preliminary, raw assessment" and that "the final decision will be made by experts who have the full benefit of a large section of opinion and scientific fact."
Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said the company was in discussions with the FDA about the drug.
Source: http://www.msn.com/
The drug, Ketek, made by Sanofi-Aventis, is currently approved only for use in adults as a treatment for sinusitis, bronchitis and pneumonia. The company is testing the drug as treatment for ear infections and tonsillitis in almost 4,000 infants and children in more than a dozen countries, including the United States, The New York Times reported Thursday.
According to a recent review by FDA safety officials, there is growing evidence that Ketek is unusually toxic -- 12 adult patients in the United States have suffered liver failure, including four who died; 23 others suffered serious liver injury. Other antibiotics cause liver failure, but Ketek seems to do so almost four times as often, the officials concluded in the review, the newspaper reported.
"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the FDA's Office of Drug Safety at the agency, wrote in one of the memorandums obtained by the Times. Other safety officials wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects, the paper said.
FDA spokeswoman, Susan Bro, asked about the Johann-Liang memorandum, said that it was "a preliminary, raw assessment" and that "the final decision will be made by experts who have the full benefit of a large section of opinion and scientific fact."
Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said the company was in discussions with the FDA about the drug.
Source: http://www.msn.com/
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