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FDA issues warning of secondary cancer risk associated with Revlimid

Filed May 9th, 2012 Laurie

The Food and Drug Administration has issued a warning recently about the risk of developing secondary cancers while taking the drug Revlimid.

According to a report from, the warnings on Revlimid (lenalidomide) were included with new safety information included with prescriptions of the drug. It has also issued the warning to physicians to be on the lookout for signs of secondary cancers developing among patients they’ve prescribed Revlimid. Doctors should also re-consider the possible benefits each patient they prescribe the drug is receiving because of it and whether or not they’re being put at an increased risk of another cancer diagnosis.

The FDA analyzed data available from several studies of Revlimid and determined that “newly diagnosed multiple myeloma patients treated with Revlimid maintenance therapy after stem cell transplantation are three times more likely to develop a second cancer than patients who do not receive Revlimid maintenance.”

In three separate ongoing trials of Revlimid, at least 7.9 percent of participants have developed a secondary form of cancer and just less than 3 percent not taking the drug developed another form of cancer. It took about two years, on average, for the secondary form of cancer to develop and the FDA identified “acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin’s lymphoma” as the cancers most likely to develop.

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