5 décembre, 2006 20:38
FDA Scientist Questions Sanofi Antibiotic Use
By Susan Heavey
WASHINGTON (Reuters) Nov 23 - A U.S. Food and Drug Administration staff scientist has questioned the continued use of the Sanofi-Aventis antibiotic Ketek, saying the agency used overseas data to overcome safety concerns raised by its outside experts.
In a letter to the New England Journal of Medicine, FDA drug reviewer Dr. David Graham said the agency used post-marketing data from Germany and France instead of requiring a new company study following a 2001 advisory panel's recommendation against approval.
The FDA will hold a public meeting next month to weigh whether Ketek should remain on the market. Known generically as telithromycin, the drug has come under scrutiny following a dozen reports of liver failure that included four deaths.
"The FDA interpreted the absence of a signal of acute liver failure in the overseas data as confirmation of telithromycin's safety," Dr. Graham said, adding that such information cannot prove a drug is safe.
"In effect, the FDA's decision in 2004 to approve the use of telithromycin... was made in the absence of reliable data disproving" the advisory panel's earlier concerns, he said in the Nov. 23 edition of the journal.
FDA spokeswoman Kristen Neese said the agency was aware of the limitations of data gathered after marketing, but it was not uncommon to use such information or reports from other countries. The agency also weighed other data in approving Ketek, she added.
Dr. Graham's letter cited a previous analysis showing that rates of liver failure with Ketek were 3.5 to 11 times higher than with other antibiotics also used to treat conditions such as bronchitis, sinusitis and pneumonia.
"Given that telithromycin is neither clinically superior to other drugs prescribed for respiratory tract infections nor uniquely life-saving, physicians, patients, and third-party payers might wish to reconsider their choice of antibiotic for such infections," he wrote.
Dr. Graham is perhaps best known for his public criticism of the FDA's drug review process following the withdrawal of Merck & Co Inc.'s Vioxx arthritis drug.
His letter comes ahead of a public meeting of an FDA advisory panel next month to discuss whether the drug should continue to be sold in the United States, despite reports of liver failure and death.
The FDA completed its safety review of Ketek in June and has said liver problems are rare but not uncommon with antibiotics. Still, the agency plans to ask its outside advisers whether the overall risk and benefits of the drug support keeping it on the market.
Sanofi added a warning to its drug in June and says it is safe and effective when used as directed. Ketek generated about $50 million in U.S. sales for the first half of 2006.
Company spokeswoman Lisa Kennedy said Ketek "has been extensively studied" and that the drugmaker was required to submit all post-marketing data to the FDA.
The antibiotic has also been the center of a Senate Finance Committee investigation over the approval amid allegations of faulty data. Last Friday, the committee's Republican chairman, Sen. Charles Grassley of Iowa, blocked a Senate vote on President Bush's nominee to lead the FDA, citing the Ketek issue.
The FDA, which has said it is cooperating with Grassley, has also said it investigated problems with the Ketek study. One doctor from the trial in question was jailed after pleading guilty to fraud.
N Engl J Med;2006;355.
