The New York Times reports that safety officials working for the Food and Drug Administration have expressed concerns over the safety of an antibiotic, Telithromycin and questioned its approval for use. The drug, marketed under the trade name Ketek, has been widely prescribed since its 2004 FDA approval. In January 2006, after cases of serious liver toxicity were reported in the Annals of Internal Medicine (a professional journal published by the American Medical Association ), the FDA issued a public advisory to that effect and, in June, 2006 announced that it had completed its safety assessment and required the manufacturer to add additional warnings about the risks of liver toxicity and for patients with myasthenia gravis to the product labeling. Apart from Dr. Graham, who also voiced safety concerns during the Vioxx scandal, three other F.D.A. officials have been identified as critics of Telithromycin's approval: Dr. Charles Cooper, Dr. David Ross and Dr. Rosemary Johann-Liang. Bipartisan congressional interest has also been triggered. Senator Charles E. Grassley (R-Iowa, chairman, Senate Finance Committee) is "investigating" the issue with Representatives Edward J. Markey (D-Mass) and Henry A. Waxman (D-Calif).
The New York Times reports that safety officials working for the have expressed concerns over the safety of an antibiotic, telithromycin and questioned its approval for use. The drug, marketed under the trade name Ketek, has been widely prescribed since its 2004 FDA approval. In January 2006, after cases of serious liver toxicity were reported in the Annals of Internal Medicine (a professional journal published by the ), the FDA issued a public advisory to that effect and, in June, 2006 announced that it had completed its safety assessment and required the manufacturer to add additional warnings about the risks of liver toxicity and for patients with myasthenia gravis to the product labeling. Apart from Dr. Graham, who also voiced safety concerns during the Vioxx scandal, three other F.D.A. officials have been identified as critics of Telithromycin's approval: Dr. Charles Cooper, Dr. David Ross and Dr. Rosemary Johann-Liang. Bipartisan congressional interest has also been triggered. Senator Charles E. Grassley (R-Iowa, chairman, Senate Finance Committee) is "investigating" the issue with Representatives (D-Mass) and (D-Calif).
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Food and Drug Administration
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Telithromycin
telithromycin
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American Medical Association
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Edward J. Markey
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Henry A. Waxman