Warning Added to Regranex Label (Aug. 2008)

A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers.

Based on a review of an earlier epidemiologic study, FDA has concluded that patients who use three or more tubes of Regranex experience a five-fold increase in the risk of cancer death compared to patients who do not use the drug. The duration of the study was not long enough to establish whether there is also an increased risk of new cancers.

In March 2008, FDA announced that it had received the epidemiologic study, described what the overall study findings were, and promised to analyze the study and communicate its findings to the healthcare community. The new boxed warning in the labeling is the result of that analysis.

Foot ulcers are a serious problem among diabetics, and yet there are few treatment options. FDA says that Regranex can be effective when it is used along with good ulcer care practices, such as controlling infection, removing dead tissue and relieving pressure. However, the boxed warning says that Regranex should only be used when the benefits are expected to outweigh the risks, and that it should be used with caution in patients with known malignancies.

Category:

Science & Technology

Tags:

• Regranex
• Warning
• FDA
• Cancer
• Death
• Patient
• Safety
• Diabetic
• Foot
• Leg
• Ulcer
• Diabetes