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Off-Label Use For Thalidomide as a Cancer Drug Questioned

A month ago, I posted a blog item about the FDA strenghtening the "X classification" on accutane to prevent pregnant women from taking the drug, which can cause serious fetal abnormalities. The plan, slated to be activated next summer, mirrors a similar program that prevented pregnant women from taking thalidomide some 45 years ago.

Thalidomide wasn't sold in the United States until six years ago, when the FDA approved it to treat leprosy and as an off-label cancer treatment. A group of Northwestern University researchers is calling for even tougher FDA policies that prevent pharmaceutical manufacturers from informing patients about potentially fatal toxicities that occur with some cancer drugs to be revised immediately, largely due to thalidomide, as it has been reported to have caused potentially fatal blood clots in the legs and lungs in some 200 cancer patients.

Researchers identified the occurrence of potential fatal blood clots in the legs and the lungs in up to 20 percent or more of cancer patients who received thalidomide. The highest rates of thromboembolism occurred in patients who received concurrent treatment with thalidomide plus chemotherapy (18 percent) versus blood clots associated with thalidomide-corticosteroid combinations (13 percent) and single-drug treatment (5 percent).

Virtually all patients who have received thalidomide over the past six years have received the drug for cancer, making this drug the only one in the country whose use is exclusively off label, researchers said. However, the FDA strictly restricts discussion or dissemination of information to physicians and patients to "on label" indications, which prevents the pharmaceutical manufacturer from advising cancer patients about the side effects of thalidomide when it is used to treat cancer.

And, despite an FDA mandate that all health care personnel and patients involved with thalidomide treatments participate in the preventive System for Thalidomide Education and Prescribing Safety (STEPS), the program does not provide patients, pharmacists or health care providers with information on thromboembolisms.

EurekAlert December 20, 2004

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