FDA Warns of Increased Risk of Second Primary Malignancies from Revlimid

The U.S. Food and Drug Administration is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma.


Revlimid is a prescription medicine approved in combination with dexamethasone to treat patients with multiple myeloma (a type of cancer of the bone marrow) who have already had prior therapy. It is also approved to treat certain patients who have certain types of myelodysplastic syndromes (a group of conditions in which the bone marrow does not produce enough mature blood cells).


This safety information has been added to the Warnings and Precautions section of the Revlimid drug label. The patient Medication Guide is also being updated to inform patients about this risk.

Healthcare professionals should consider both the potential benefit of Revlimid and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk. Patients should contact their healthcare professional if they have any questions or concerns about Revlimid.


In April 2011, the FDA announced an ongoing safety review to evaluate the possible increased risk of second primary malignancies with Revlimid. The FDA performed a comprehensive review of this safety issue.


See the FDA Safety Announcement