Editor's note: Regranex, a gel made by Johnson & Johnson and used by diabetes patients, may increase risk of cancer and death, US health officials said Tursday. The FDA said the gel may increase risk cancer deaths in patients who had been prescribed the gel three or more times. Regranex was approved in 1997 to help treat diabetic leg and foot wounds. See below for the details:
Communication about an Ongoing Safety Review Regranex (becaplermin)
This
information reflects FDA’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. 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.
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. 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. There was not
enough information to say whether there was an increase in the number
of patients that developed new cancers.
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. 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. 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 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.
No single type of cancer was identified, but rather deaths from all
types of cancer, combined were observed.
This
communication is in keeping with FDA’s commitment to inform the public
about its ongoing safety reviews of drugs. 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.
