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FDA Drug Safety Podcast for Healthcare Professionals: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic:  Safety review update of cancer drug Revlimid, active ingredient lenalidomide, and risk of developing new types of malignancies

Kara Daniel, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On May 7, 2012, the FDA issued a Drug Safety Communication informing the public of an increased risk of second primary malignancies in patients with newly-diagnosed multiple myeloma who received Revlimid. 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.

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.

At this time FDA recommends that Healthcare Professionals:

  • Know that, 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 to 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 at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 

 

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