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FDA Panel Wants Anemia Drug Warnings

Experts Concerned Drugs Are Overprescribed Despite Risks

Marketing Questioned continued...

"Most doctors and most patients think this drug has been approved because it improves quality of life, it improves fatigue. There's a lot of sleight of hand here on how the drug is used ... and that's a problem," says Otis Brawley, MD, a professor of oncology at Winship Cancer Institute at Emory University in Atlanta and a member of the panel.

Maha H.A. Hussein, MD, the panel's chairwoman, says she doesn't want to see the drugs pulled from the market because they are important for "supportive care." But she also suggests that company marketing has urged doctors to give higher-than-recommended doses under the assumption that boosting red blood cell counts translated to more comfort for patients.

"We started out with a huge problem, which is the ad campaign problem," says Hussein, a professor of medicine at the University of Michigan.

Doctors are allowed to prescribe drugs for any reason, but FDA regulations forbid companies from promoting drugs for unapproved uses.

Richard Pazdur, MD, head of the FDA office in charge of cancer drugs, says agency officials are looking into why apparently aggressive promotional campaigns were left unchecked.

"There's a lot of concern that these are being promoted with quality-of-life claims that are not in the label," he says. "I think they need to give the American public a clear understanding as to why these ads were allowed to continue."

Experts Thursday urged the agency to go further in restricting use of the drugs in cancer patients, though they provided little clear guidance on what those restrictions should be. Experts said the agency should consider discouraging the drugs' use in patients with several forms of cancer. They also urged that doctors be warned to discontinue using the drugs once chemotherapy is stopped.

The FDA's actions depend in large part on the results of several ongoing studies, Pazdur says.

The drugs are also approved for use in patients with kidney failure. FDA officials said they were planning a public review of the drugs' safety in those patients for the fall.

"We will be working the FDA as they consider the committee's recommendations," says Amgen spokeswoman Trish Hawkins.


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