Diabetic Ulcer Gel Gets Black Box Warning

Yael Waknine


June 09, 2008

June 9, 2008 — A black box warning has been added to the safety labeling for becaplermin gel (Regranex, Johnson & Johnson) to warn of the increased risk for cancer mortality in patients who use 3 or more tubes of the product, the US Food and Drug Administration (FDA) announced on Friday.

The action follows an FDA safety review that was initiated in March 2008 after a postmarketing retrospective cohort study revealed an overall increase in the number of cancer deaths in becaplermin-exposed patients compared with similar patients who had not been exposed. At that time, insufficient information was available to determine whether the incidence of cancer was also increased.

The agency has now concluded that the risk for cancer mortality was 5-fold higher in patients exposed to 3 or more tubes of becaplermin, but that the results were "consistent with no overall increase in cancer incidence."

According to study data included in the new labeling, the adjusted rate ratio for overall cancer incidence among becaplermin-treated patients was 1.2 (95% confidence interval [CI], 0.7 – 1.9), and the corresponding death rate ratio was 1.8 (95% CI, 0.7 – 4.9).

For patients who had been exposed to 3 or more tubes of the gel, the adjusted mortality rate ratio was 5.2 (95% CI, 1.6 – 17.6), with an actual incidence rate of 3.9 cancer deaths per 1000 person-years of treatment.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," Susan Walker, MD, director of the Division of Dermatological and Dental Products, says in a news release. "Regranex is not recommended for patients with known malignancies."

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.

Clinicians are urged to report becaplermin-related adverse events 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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