Clinical safety of becaplermin (rhPDGF-BB) gel. Becaplermin Studies Group.

This overview of the safety of becaplermin gel is based on six well-controlled clinical studies that included patients with lower extremity diabetic neuropathic ulcers. Patients receiving becaplermin gel (n = 538), placebo gel (n = 278), or good ulcer care alone (n = 190) had a similar incidence of ulcer-related adverse events, such as infection, cellulitis, or osteomyelitis. Erythematous rash occurred in 2% of patients with suspected wound infections treated with becaplermin gel and 1% of patients treated with placebo gel. No rashes were observed in patients treated with good ulcer care alone. The incidence of cardiovascular, respiratory, musculoskeletal, and central and peripheral nervous system disorders were similar across all treatment groups. Mortality rates were also similar across all treatment groups. Patients treated with becaplermin gel did not develop neutralizing antibodies against becaplermin. Therefore, becaplermin gel appears to be a safe therapy for the treatment of lower extremity diabetic ulcers.