Regranex (becaplermin) is a cicatrizant (promotes healing through the formation of scar tissue) available as a topical gel used to treat diabetic foot and leg ulcers that do not heal by themselves. Becaplermin contains a human growth hormone that promotes the growth of cells when applied over the wound. Regranex, however, should not be applied over any wound or surgical incision that has been closed with staples, stitches, or surgical tape.
Regranex is typically used as only part of an ulcer care treatment program that usually includes routine foot/leg examinations and avoiding weight on the affected foot/leg. Patients are cautioned to follow doctor's instructions carefully.
In June 2008, the Food and Drug Administration (FDA ) announced the addition of a boxed warning on the label of Regranex Gel 0.01% addressing the increased risk of cancer death in patients who use three or more tubes of the medication.
In a long term study that was begun prior to Regranex's approval in December 1997, and completed in 2001, there were more cancers in people who used the medication than in those who did not. So an additional study was undertaken using a health insurance database that covered a period of five and a half years. The analysis revealed that there were five times more cancer deaths among patients who were given three or more prescriptions for treatment with Regranex than among those who were not treated with Regranex.
No single type of cancer was identified, but rather deaths from all types of cancer. And the FDA had also not concluded that there is a direct causal relationship between the use of Regranex and an increased risk for cancer death. The agency, however, was compelled to caution health care professionals to carefully weigh the risks and benefits of treating patients with Regranex, and to recommend against its use for patients with cancerous tumors.
Additional potential side effects of Regtanex for which medical attention should be sought immediately include severe allergic reactions, such as rash, hives, itching, tightness in the chest, difficulty breathing, swelling of the mouth, tongue, face, or lips; and irritation.
If you or a loved one has been injured by, or suffered severe side effects from, the use of Regranex, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.