Revlimid (lenalidomide): Increased Risk of New Malignancies

Drug Alerts , News / September 30, 2016

The FDA notified the public of an increased risk of secondary primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide).

Clinical trials conducted after the approval of Revlimid showed that newly diagnosed patients treated with Revlimid had an increased risk of developing secondary primary malignancies compared to similar patients who received a placebo. In particular, 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 developing secondary primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk during therapy.

[August 4th, 2011] FDA is informing public that it is aware of results from clinical trials conducted inside and outside the United States, finding that patients treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer, compared to patients not taking the drug. A current review of all available information on this potential risk is underway, and any new recommendations will be communicated accordingly.

Revlimid is used to treat a type of blood disorder known as myelodysplastic syndrome. It is also used along with other drugs to treat people with a type of cancer known as multiple myeloma.

At the time being, there is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated according to the FDA-approved indications.

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