Label Changes for:

Regranex (becaplermin) Gel 0.01 %

October 2008

Changes have been made to the BOXED WARNING and WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING (new)

WARNINGS

  • ...In a follow-up study, 491 (75%) of 651 subjects from two randomized, controlled trials of becaplermin gel 0.01% were followed for a median of approximately 20 months to identify malignancies diagnosed after the end of the trials...
  • ...In a retrospective study of a medical claims database, cancer rates and overall cancer mortality were compared between 1,622 patients who used Regranex Gel and 2,809 matched comparators...

BOXED WARNING (new)

WARNING:

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of Regranex Gel in a post-marketing retrospective cohort study. Regranex Gel should only be used when the benefits can be expected to outweigh the risks. Regranex Gel should be used with caution in patients with known malignancy. (See CONTRAINDICATIONS and WARNINGS).

WARNINGS (See highlighted prescribing information for new text).

Regranex Gel contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. (See Clinical Pharmacology). The benefits and risks of becaplermin treatment should be carefully evaluated before prescribing. Becaplermin should be used with caution in patients with a known malignancy.

Malignancies distant from the site of application have occurred in becaplermin users in both a clinical study and in postmarketing use, and an increased rate of death from systemic malignancies was seen in patients who have received 3 or more tubes of Regranex Gel.

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