Regranex is manufactured by Johnson & Johnson, and was approved by the FDA in 1997. Since its debut, it has been used by more than 750,000 patients, and in June 2008 the FDA announced the addition of a black box warning to the drug’s label. The label stated that patients who use the gel were at a higher risk of dying from cancer with the use of three or more tubes of Regranex.

Regranex is a recombinant form of human platelet-derived growth factor that has biologic activity that is much like what is produced naturally in the body. These growth factors cause cells to divide more rapidly, and they have been associated with tumor growth. For this reason, the drug is contraindicated fro use in people with a history of skin cancer.

In March 2008, the FDA announced its review of the safety of Regranex after seeing the results of two studies which indicated that it put patients at higher risk of cancer death. The first indicated that there were more cancers in people who used the drug than those that did not.  Another study found an increase in the number of cancer deaths among patients who had been prescribed the drug three or more times. The FDA has found a five-fold increased risk of cancer deaths in the group exposed to three or more tubes of Regranex. The attorneys of the Singleton Law Firm are actively researching these instances and want to assist individuals affected by this medication.

The label of Regranex can be quoted, “An increased rate of mortality secondary to malignancy was observed in patients treated with three 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.”

Contact the Singleton Law Firm for additional information and a free case evaluation if you or someone you know have used the drug Regranex.