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FDA adds boxed warning to becaplermin
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The risk for cancer mortality is increased among patients exposed to large amounts.
The FDA has added a boxed warning to becaplermin based on results from a retrospective trial. The warning addresses the increased risk of cancer mortality related to using three or more tubes of the topical cream.
Becaplermin, a recombinant human platelet-derived growth factor marketed by Ortho-McNeil Pharmaceutical Inc. (Regranex gel 0.01%), is indicated for the treatment of diabetic neuropathic ulcers of the legs and feet.
The FDA issued an Ongoing Safety Review Communication in late March that informed the public that is was conducting a safety review of the product.
Becaplermin received FDA approval in December 1997. In 2001, results of a long-term safety study reported that patients using the medication had higher mortality than those who did not use it.
An follow-up trial compared the incidence of cancer and cancer mortality between 1,622 patients exposed to becaplermin to 2,809 similar patients not exposed. Data were taken from a health insurance database that included information from January 1998 through June 2003.
No overall increase in cancer incidence was reported in patients exposed to becaplermin, but the risk was increased fivefold among those prescribed three or more tubes. Deaths from all types of cancer combined were reported with no single cancer type identified. – by Stacey L. Adams
For more information:
- Visit the FDA website: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01845.html