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.
Moreover, 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.
Evens presented the RADAR (Research on Adverse Drug Events and Reports) data on the thalidomide-associated blood clots on at the 46th Annual Meeting of the American Society of Hematology in early December.
The Northwestern study 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.