U.S. Panels Begin Hearings on Antibiotic's Safety

Company defends Ketek while FDA defends 2004 approval of controversial drug

THURSDAY, Dec. 14 , 2006 (HealthDay News) -- The manufacturer of the controversial antibiotic Ketek defended its safety while U.S. health officials defended its approval, as two days of safety hearings got underway Thursday.

In testimony before two U.S. Food and Drug Administration advisory panels, representatives of Sanofi-Aventis, which manufactures Ketek (telithromycin), claimed the drug was no more dangerous than similar antibiotics and was more effective against drug-resistant bacteria.

And at the end of the hearing, FDA officials justified the use of post-marketing data from Europe to approve the drug in April 2004.

Ketek is used to treat certain types of bronchitis, sinusitis and pneumonia. But since its approval, more than 600 cases of liver damage, loss of consciousness and other side effects have been reported, Bloomberg News reported.

"Use of post-marketing data is not unusual. It's not as if we relied solely on post-marketing data from Europe," Dr. John Jenkins, director of the FDA's Office of New Drugs, Center for Drug Evaluation and Research, explained during a news conference late Thursday.

"We had a substantial safety database on Ketek at the time of approval, far in excess of standard guidelines, and we supplemented that with post-marketing surveillance data from Europe to help us address specific questions," he added.

Before approving the drug, the FDA also took the unusual step of requesting a prospective safety trial. "That goes far beyond the internationally recognized accepted standards for the amount of data needed for approval," Jenkins said. "We wanted to assure ourselves that liver injury was not a common adverse event."

The two advisory committees are now meeting to discuss safety issues with the drug and may possibly recommend labeling changes or even its removal from the market.

Other experts not involved with the hearings questioned whether the drug should be on the market at all.

"I have never written a prescription for Ketek," said Dr. Douglas Hurley, a professor of internal medicine at Texas A&M Health Science Center. "It doesn't provide anything we don't have with a number of other drugs; so quite honestly, I don't see it as being all that important."

"It's not horribly unsafe," Hurley added. "There are some cases of liver failure, which can happen with any number of drugs. But why take the risk?"

In June, Sanofi agreed to update Ketek's labeling to reflect the possibility of severe liver damage.

Last month, a European Medicines Agency panel recommended that Ketek not be given to patients with a history of such liver conditions as hepatitis or jaundice.

But much more than a drug may be on trial here.

The U.S. Senate Finance Committee is investigating allegations of fraud involving clinical trials of Ketek and is looking into how the FDA handled Ketek-related safety issues.

According to Bloomberg, Sen. Charles Grassley, an Iowa Republican, accused the FDA of withholding relevant information at the time of the drug's approval.

The FDA "can't be in the business of misleading the public and hiding the truth," and "the integrity of the agency is at stake," Grassley said in a statement Wednesday.

Grassley asked FDA Commissioner Dr. Andrew von Eschenbach to respond by Jan. 17 to allegations that the agency had knowingly used fraudulent safety data to approve Ketek, Bloomberg reported.

Asked Thursday to respond to the allegations in the letter, Jenkins replied, "There will be an official response to the document. I don't want to get into the details of that."

More information

For more on the briefings, visit the U.S. Food and Drug Administration.

SOURCES: Dec. 14, 2006, teleconference with John Jenkins, M.D. director, Office of New Drugs, Center for Drug Evaluation and Research, FDA; Douglas L. Hurley, M.D., professor, internal medicine, Texas A&M Health Science Center, and an infectious disease doctor, Scott & White Hospital; Bloomberg News
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