Food and Drug Administration policies prevent pharmaceutical manufacturers from informing patients about potentially fatal toxicities that occur with some cancer drugs -- policies that should be revised immediately, according to Northwestern University researchers.
Andrew M. Evens, D.O., instructor in medicine, and Charles L. Bennett, M.D., professor of medicine, Northwestern University Feinberg School of Medicine, have called for an immediate revision of these FDA policies, particularly because the drug thalidomide, which was approved by the FDA as an off-label cancer treatment in 1998, has been reported to have caused potentially fatal blood clots in the legs and the lungs in over 190 cancer patients.
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. 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.
Elizabeth Crown | EurekAlert!
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