Chymopapain injections can, in rare cases, cause serious and even
fatal side effects, including bleeding, infections, nerve damage,
paralysis and anaphylaxis (a life-threatening allergic reaction).
Drugs are sometimes withdrawn from the market by their manufacturers
for economic or legal reasons unrelated to the drug's effectiveness.
According to the U.S. Food and Drug Administration, chymopapain (sold
under the brand names Chymodiactin and Discase) was withdrawn from
sale by its manufacturer for reasons other than safety or
effectiveness. It is currently on the FDA's "Discontinued Drugs" list.
When another manufacturer decides to undertake its manufacture and
distribution, chymopapain injections could become available again.
"Chemonucleolysis is a treatment in which an enzyme, chymopapain, is
injected directly into a herniated lumbar disc... in an effort to
dissolve material around the disc, thus reducing pressure and pain.
The procedure's use is extremely limited, in part because some
patients may have a life-threatening allergic reaction to
chymopapain."
WrongDiagnosis.com: Treatments for Pain
http://www.wrongdiagnosis.com/p/pain/treatments_printer.htm
"A controversial alternative to surgery is injecting chymopapain into
a herniated disk. Chymopapain, an enzyme obtained from the papaya
plant, breaks down the noncollagen components of the nucleus pulposus.
The procedure was introduced in the mid-1960s, and the FDA approved
its use in 1983.
While chymopapain injection may be effective at relieving pain in
about 70 percent of patients, this procedure has been viewed with
suspicion by many orthopedic surgeons and neurosurgeons (although it
is used with greater frequency in Japan and Europe). The most serious
adverse effects are anaphylaxis (severe respiratory symptoms and
circulatory collapse triggered by an allergic reaction) and
neurological complications."
Johns Hopkins White Paper on Back Pain & Osteopororis
http://www.usnews.com/usnews/health/bones/back-pain/back.treat.part.hernchymo.htm
"This survey covers 121 'serious' and 'unexpected' adverse events
after treatment with chymodiactin (chymopapain for injection) among
approximately 135,000 patients in the United States. They were
reported to the Food and Drug Administration (FDA) within 15 days of
notification of the manufacturer between 1982 and the end of 1991.
They included fatal anaphylaxis (seven cases), infections (24 cases),
hemorrhage (32 cases), and neurologic (32 cases) and miscellaneous (15
cases) events, with a mortality rate of 0.019%. Anaphylactic reactions
reported in a postmarketing survey can be attributed to chymopapain
itself and infections to lack of asepsis during its administration.
The causes of other adverse reactions cannot be as clearly defined,
but many are unlikely to have been due to chymopapain or its
administration."
Abstract of "Safety of chemonucleolysis. Adverse effects reported in
the United States, 1982-1991."
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8339472&dopt=Abstract
"Chymopapain (KYE-moe-pa-pane) is injected directly into a herniated
('slipped') disk in the spine to dissolve part of the disk and relieve
the pain and other problems caused by the disk pressing on a nerve...
Very rarely, use of chymopapain may cause serious side effects,
including paralysis of the legs or death. Another dangerous side
effect of chymopapain injection is a severe allergic reaction called
anaphylaxis. This side effect occurs in less than 1% of the patients
receiving the medicine, but it occurs more often in women than in
men."
Drugs.com: Chymopapain
http://www.drugs.com/cons/Chymopapain.html
"After many years of animal testing and FDA studies, in 1981, a
randomized study, sanctioned by the FDA, on 108 patients revealed
success rates of chymopapain at 82% versus 41% in the placebo treated
group with no serious complications. At about the same time, a larger
study included 1500 patients and revealed a success rate of 90% with
only four reported cases of anaphylaxis (an acute allergic reaction).
In November of 1982, largely on the basis of these studies,
chymodiactin received FDA approval. Over the ensuing years
approximately 120,000 patients received chymopapain, unfortunately, 46
individuals experienced serious neurologic complications, including
paraplegia and transverse myelitis. By 1984 the FDA had modified the
administration procedures in an effort to minimize these
complications. Currently, the complication rate is believed to be
about 0.2 to 0.5%.
In spite of the concern for untoward reactions, in depth comparison
reveals a rate of significant neurologic complications to be at 4.7
per 10,000 patients, or six times less than traditional open
discectomy procedures. The infection rate is 1.8 per 10,000 versus
30.7 per 10,000 with surgery."
Spine Doctor: Chemonucleolysis
http://www.spine-dr.com/site/surgery/surgery_article6.html
"The agency has determined that CHYMODIACTIN (chymopapain 10,000
units/vial injection) was not withdrawn from sale for reasons of
safety or effectiveness. Abbott Laboratories informed the agency by
telephone that the company no longer markets CHYMODIACTIN. FDA has
independently evaluated relevant literature and data for possible
postmarketing adverse event reports, but has found no information that
would indicate this product was withdrawn for reasons of safety or
effectiveness."
Food and Drug Administration: Docket No. 02P-0068
http://edocket.access.gpo.gov/2003/03-1742.htm
"Chymopapain is an enzyme derived from the papaya, it has been used
successfully for the past 25 years in more than 400,000 patients for
the treatment of sciatica resulting from lumbar disc herniation. It is
currently unavailable, but a company, Spinal Therapies, LLC has been
formed to manufacture and distribute chymopapain worldwide. It is
expected that chymopapain will be available again by late 2005. Used
appropriately, chymopapain the drug used in chemonucleolysis has
repeatedly been shown to be both safe and effective in sixteen
randomized controlled trials, five of which were placebo comparison
trials. Serious complications following chymopapain have been reported
at a rate of 1/10 of those following laminectomy/discectomy. While the
deaths reported following laminectomy/discectomy are rare the reported
deaths following chymopapain occur at 1/3 that rate."
International Intradiscal Therapy Society: Frequently Asked Questions
http://www.iits.org/faq.html
My Google search strategy:
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Google Web search: chymopapain "side effects"
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Google Web Search: chymopapain discontinued
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Google Web Search: chymopapain fda OR "food and drug administration"
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I hope this is helpful. If anything is unclear or incomplete, please
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pinkfreud |
