[04-08-2011] The U.S. Food and Drug Administration (FDA) is informing the public that we are aware of results from clinical trials conducted inside and outside the United States 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.
- Do not stop taking Revlimid without talking to your healthcare professional.
- Discuss any questions or concerns about Revlimid with your healthcare professional.
- Continue to report any side effects you experience to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.
- 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 shows an increased incidence of some second primary malignancies, particularly acute myelogenous leukemia (AML) and B-cell lymphoma malignancies, when compared to controls.
- Since lenalidomide is an analogue of thalidomide, FDA is also currently reviewing all available information on this potential risk for thalidomide.
- 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 risks and will communicate any new recommendations once it has completed its review.
- Continue to report adverse events involving Revlimid to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.
FDA is currently reviewing all available new information on this potential risk and at this time, recommends caution when interpreting these results. Currently, FDA believes the benefits of Revlimid continue to outweigh the potential risks. Patients should continue to follow the advice of their healthcare provider. FDA will communicate with the public as soon as we have more information.
- FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies
- FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies