Becaplermin Gel (Regranex) and Risk of Cancer Death - Ongoing Safety Review
June 10 , 2008
FDA informed healthcare professionals of an ongoing analysis of safety data of becaplermin gel (Regranex). An analysis of an insurance plan database evaluated diabetic patients at least 19 years old with no prior history of cancer. The analysis found a higher rate of cancer-related death in patients who received at least 3 prescriptions for becaplermin gel, compared to those who did not receive becaplermin gel.
FDA has completed its review of the study and reports that patients using three or more tubes of becaplermin had a five-fold higher risk of death from cancer than patients not using becaplermin. The risk of getting a new cancer was the same in both groups, but a short follow-up period may not have allowed for any differences in new cancers to be detected.
The package labeling for becaplermin now includes a Boxed Warning including information about the increased risk of death from cancer. FDA recognizes that becaplermin is an effective medication for the treatment of diabetic ulcers, and that proper treatment of such ulcers can decrease hospitalization in these patients. However, the FDA recommends weighing the potential benefit of becaplermin with its risks before use.
Additional information is available at the following links:
- FDA MedWatch alerts:
- Early Communication about Ongoing Safety Review:
- Update of Safety Review:
- Updated Product Labeling:
June 10, 2008; March 27, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.