Applies to becaplermin topical: topical gel/jelly.

Serious side effects of Becaplermin topical

Along with its needed effects, becaplermin topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking becaplermin topical:

Less common

• Rash or redness of the skin near the skin ulcer

Incidence not known

• Burning sensation at the application site
• unusually warm skin

For Healthcare Professionals

Applies to becaplermin topical: topical gel.

Oncologic

Eight of 291 patients (2.7%) on this drug versus 2 of 200 placebo patients (1%) in 20 month clinical trial follow up studies developed cancer; types of cancer varied and all were remote from the treatment site.

Three retrospective postmarketing studies showed an increased death rate from systemic malignancies in patients who had used 3 or more tubes of becaplermin.^[Ref]

Common (1% to 10%): Cancer

Postmarketing reports: Increased death rate from systemic malignancies^[Ref]

Dermatologic

Common (1% to 10%): Erythematous rash^[Ref]

Local

Postmarketing reports: Burning sensation at application site, erythema at application site^[Ref]