FDA Drug Safety Communication

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FDA Date: 4/8/11

FDA Drug Safety Communication for Revlimid (lenalidomide)

Ongoing Safety Review of Revlimid (lenalidomide) and Possible Increased Risk of Developing New Malignancies

FDA is informing the public of results from clinical trials conducted inside and outside the U.S. that found that patients treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug.

At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their healthcare provider.

The benefits and the risks of Revlimid should be carefully weighed when prescribing this drug. Healthcare professionals should be aware that Revlimid may increase the risk of developing another type of cancer.

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

Preliminary data derived from evaluation of outcomes after longer-term exposure to Revlimid and from controlled clinical trials conducted inside and outside the Unites States show an increased incidence of some second primary malignancies, particularly acute myelogenous leukemia (AML) and B-cell lymphoma malignancies, when compared with controls.

At this time, there is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated according to the FDA-approved indications. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

Since lenalidomide is an analogue of thalidomide, FDA is also currently reviewing all available information on this potential risk for thalidomide.

View the full FDA Drug Safety Communication on FDA.gov