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Safety review of becaplermin gel (Regranex, Johnson & Johnson) is being conducted after study results suggested an increased risk for cancer-related mortality, the US Food and Drug Administration (FDA) warned healthcare professionals last week. In the study, a health insurance database was used to identify 2 groups of diabetic patients aged 19 years and older with similar diagnoses, drug use, and use of health services from January 1998 through June 2003. One group had been prescribed becaplermin gel, and the other had not.
Analysis revealed an overall increase in the number of cancer deaths among patients who had been prescribed the gel 3 or more times for diabetic foot and leg ulcers. Insufficient information was available to determine whether there was an increase in the incidence of new cancers, the FDA said.
The findings supported those of a long-term study completed by the manufacturer in 2001, which also showed more cancers in patients using becaplermin compared with those who did not.
While the review is ongoing, the FDA recommends that healthcare professionals discuss the potential risks and benefits of becaplermin gel with their patients, according to an alert issued by MedWatch, the FDA’s safety information and adverse event reporting program.
Becaplermin 0.01% gel is a recombinant form of human platelet–derived growth factor that is indicated for the treatment of lower extremity diabetic neuropathic ulcers with an adequate blood supply that extend into the subcutaneous tissue or beyond.
Adverse events associated with use of becaplermin gel should be reported to the FDA’s MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
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