Drug Safety Communication Issued Regarding Lenalidomide and Risk of New Malignancies


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The FDA recently released a safety announcement about an increased risk of second primary malignancies in patients with newly diagnosed multiple myeloma who received treatment with lenalidomide (Revlimid). Clinical trials conducted after lenalidomide was approved showed that newly diagnosed patients treated with the drug 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.

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

Health-care professionals should consider both the potential benefit of lenalidomide 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. ■



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