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FDA Safety Official Wants Controversial Antibiotic Ketek off the Market
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ShareJuly 19, 2006 1:53 PM
In an internal FDA memo obtained by ABC News, a prominent FDA safety official called for the "immediate withdrawal of Ketek" from the market.
In the June 16 memo, Dr. David Graham, an associate director in the FDA's Office of Drug Safety, said Ketek is as harmful to the liver as "most, if not all drugs previously withdrawn from the market" because of severe liver toxicity.
Ketek, an antibiotic used to treat respiratory infections, has been beset with controversy following reports of dozens of liver injuries and four deaths among Ketek patients. In addition, the results of a clinical safety trial on Ketek were called into question after the director of the largest trial site was convicted of falsifying patient information. Despite these concerns, the FDA approved Ketek in 2004, based largely on patient data from Europe and Latin America.
In his memo, Dr. Graham harshly criticized the FDA's approval process, stating, "It's as if every principle governing the review and approval of new drugs was abandoned or suspended." Graham said relying on other countries' safety information was a "great abuse of such surveillance data" given the fact that their reporting systems were "far less complete" than in the U.S.
With criticism mounting, last month the maker of Ketek, Sanofi-Aventis, agreed to a stronger warning label detailing the risks of liver problems. However, in his memo, Dr. Graham stated, "I don't think this is an issue that can or should be dealt with by labeling." According to Graham, Ketek should no longer be sold, saying, "We're flying blind as far as safety goes."
Sanofi-Aventis has said the benefits of Ketek outweigh the potential risks. The FDA has said it approved Ketek after a rigorous review by top doctors, scientists and statisticians.
Read Dr. Graham's internal memo on Ketek.
July 19, 2006 | Permalink | User Comments (2)
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Dr Graham's been noted for letting the public know about the dangers of medicine's that the FDA has approved and he is an employee of theirs so I would like to give him credit for standing up to what he is hired to do while others look the other way for the almighty dollar.
Posted by: suzie | Jul 19, 2006 9:52:26 PM
If not for Dr. David Graham's perseverance and bravery, the movement beginning to reform the United States Food and Drug Administration (FDA) would never have happened. I don't know how Dr. Graham had the emotional and physical strength to go to work at the FDA day in and day out with many co-workers who no doubt viewed him as a whistle blower. I hope Dr. Graham's courage and bravery will inspire more of his co-workers to line up behind him so Americans have a reason to begin trusting the FDA. There was a time when the stamp of approval from the FDA meant something. Today, Americans are left to educate themselves regarding the risks versus the benefits of prescription drugs, off label use of prescription drugs, investigational drugs, food safety, doctors versus research scientists, etc. I think Dr. Graham's day in the sun has finally arrived. Thank you Dr. Graham for putting the health of Americans before the almighty dollar!
Posted by: Katie | Jul 24, 2006 7:03:06 AM
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