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FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies


Safety Announcement

Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

Safety Announcement

 
[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.
 
FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
 
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.
 

Additional Information for Patients and Caregivers

  • 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.

 

Additional Information for Healthcare Professionals

  • 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.

 

Data Summary

In summary, FDA is aware of the results of controlled clinical trials that showed a higher rate of second primary (new) 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.
 
Revlimid (lenalidomide) 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 (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
 

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.

 

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