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Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
The FDA 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 with 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.
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.
In April 2011, FDA announced an ongoing safety review to evaluate the possible increased risk of second primary malignancies with Revlimid. FDA performed a comprehensive review of this safety issue.
Additional information for healthcare professionals:
- In clinical trials of patients newly diagnosed with multiple myeloma, those patients treated with Revlimid had an increased risk of developing second primary malignancies, particularly acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma compared with patients receiving a placebo.
- Monitor patients taking Revlimid for the development of second primary malignancies.
- Take into account both the potential benefit of Revlimid and the risk of second primary malignancies when considering treatment with Revlimid.
- Encourage patients to read the Medication Guide when they receive their Revlimid prescription.
- Please continue to report adverse events involving Revlimid to the FDA MedWatch program