FDA issues a Communication about an Ongoing Safety Review Regranex (becaplermin)
Communication about an Ongoing Safety Review Regranex
This information reflects FDAâ€™s current analysis of available data concerning this drug. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue.Â Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
ROCKVILLE, Md., March 28, 2008--FDA has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers.Â This study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer.Â There was not enough information to say whether there was an increase in the number of patients that developed new cancers.Â
At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex.Â Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient.
What does FDA know now about these data?
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. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 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.Â 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.Â The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex.Â No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.
This communication is in keeping with FDAâ€™s commitment to inform the public about its ongoing safety reviews of drugs.Â FDA will communicate our conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed.
The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program, as described below.Âonline at www.fda.gov/medwatch/report.htm by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787 faxing the form to 1-800-FDA-0178 by phone at 1-800-332-1088
Posted: March 2008