As a point of clarification, neither Panafil nor
Accuzyme were ever FDA approved drugs. These
products existed because their active
ingredient (papain) was in use prior to Congress
amending the original Food and Drug Act in 1938
(which required manufacturers to demonstrate
safety of new drugs). Thus, manufacturers did
not have to demonstrate safety and efficacy of
any marketed product containing papain as its
active ingredient. It's a loophole that exists
for thousands of other drug products as well,
i.e. colchicine, as previously mentioned in
this discussion.>p?
The FDA ordered companies to stop marketing
unapproved drug products that contain papain in
a topical dosage form on November 24, 2008. The
FDA's rationale primarily involved several
safety concerns, as well as the fact that the
effectiveness of these products is not supported
by scientifically sound studies in the medical
literature.
Anecdotally, I've heard a report of a patient
who died from exsanguination after a
papain-urea product was inadvertently applied to
a blood vessel in a large abdominal wound. It's
conceivable that this event may have played a
part in triggering action by the FDA.
Santyl is the only FDA-approved enzymatic
debriding agent currently on the market.
Another alternative would be to use an 'FDA
unapproved' product containing trypsin (a mild
debriding agent), such as Xenaderm
ointment.
For more information on this decision by the
FDA, see:
http://tinyurl.com/6ezjmky
Disclosure: I am a consultant for Healthpoint
Biotherapeutics, current manufacturer of Santyl
and Xenaderm, and former manufacturer of
Accuzyme and Panafil).
Robert Wunderlich, DPM, San Antonio, TX,
rwunder@gmail.com
