FDA to Investigate Regranex Link to Cancer DeathsMar 27, 2008 | Parker Waichman LLP
Regranex, a gel used by diabetics to treat leg and foot wounds, has been linked to an increased incidence of cancer and deaths, prompting the Food & Drug Administration (FDA) to announce a Regranex safety review.
Regranex, manufactured by Johnson & Johnson, is a topical medicine that was approved by the FDA in 1997 to treat leg and foot ulcers in patients with diabetes. Patients with diabetes - a disease in which the body cannot make insulin and affects blood sugar levels - are more susceptible to developing leg and foot wounds because they are less able to feel their feet.
Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. For that reason, the FDA said Johnson & Johnson continued to monitor studies begun before Regranex was approved for any evidence of adverse effects such as increased numbers of cancers.
In a long term safety study completed in 2001, there were more cancers in people who used Regranex than in those who did not use it. Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. The patients involved in the study where people with diabetes who were at least 19 years of age or older, with no history of cancer . This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not.
The second Regranex study found an increase in the number of cancer deaths among patients who had been prescribed Regranex three or more times. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed. The FDA also said there was not enough information to determine whether there was an increase in the number of patients that developed new cancers.
At this time, the FDA says it believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex. Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the FDA cautioned that the potential risk of using Regranex should be weighed against the benefit for each individual patient.