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FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On April 8, 2011, the Food and Drug Administration issued a Drug Safety Communication 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, active ingredient lenalidomide, may be at an increased risk of developing new types of cancer compared to patients who did not take the drug.  

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.

Revlimid is approved for use, in combination with dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Revlimid is also approved for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

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.

FDA is aware of the results of controlled clinical trials that showed a higher rate of second primary malignancies among patients who were treated with Revlimid compared with those who were not. Data from evaluation of outcomes after long-term treatment also showed numerous second primary malignancies.

FDA recommends that patients continue their Revlimid treatment as prescribed by their healthcare provider. 

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.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. 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 and B-cell lymphoma malignancies, when compared to controls.
  2. Since lenalidomide is an analogue of thalidomide, FDA is also currently reviewing all available information on this potential risk for thalidomide.
  3. 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.
  4. Adverse events involving Revlimid should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. To learn more about this Drug Safety Communication, go to www.fda.gov/Drugs.  If you have drug questions, you can reach us at druginfo@fda.hhs.gov. 


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