Article date: April 2010
Becaplermin (Regranex) is a topical gel indicated to promote the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2,in association with other good wound care measures.
A retrospective observational study (unpublished) has raised concerns of a link between becaplermin and malignancies distant from the site of application. The study had several limitations in its design and the evidence is not robust. However, as a precaution, a letter has been sent to healthcare professionals in March 2010 to inform them of the contraindication of becaplermin in patients with any known malignancy.
Advice for healthcare professionals:
- review treatment at the next routine appointment and do not prescribe becaplermin to patients who have a current cancer at any site.
- ulcers with a suspicious appearance should be biopsied to exclude malignancy.
Further information from the European Medicines Agency:
Press release and Questions and answersPress release and Questions and answers
Article citation: Drug Safety Update April 2010, vol 3 issue 9: 10.