INDICES> misoprostol/diclofenac combination

["C.I.M.F" <cimf@colfarma.org.ar>]

INDICES> misoprostol/diclofenac combination
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[crossposted from E-drug as it has relevance for Drug info Centres; WB]

Dear Colleagues:

I'm Edith Delvechio. I'm from Argentina and I work at the Pharmaceutical
Drug Information Centre of the College of Pharmacists of the College of
Buenos Aires.

In our country we are starting to have problems related to the bad use of
the association Diclofenac/Misoprostol. This association is indicated to
reduce the gastrointestinal effects of NSAIDs, in this case Diclofenac,
which inhibits non selectively both isoforms of the enzime cyclooxigenase -1
and -2. By this mechanism it inhibits the synthesis of the gastroprotective
prostaglandins (PG-E1), and in this case misoprostol comes to replace this
authacoid. Misoprostol  increases the amplitude and frequency of the uterine
contractions, and stimulates uterine bleeding and total or partial expulsion
of the uterine contents in pregnant women.
It is indicated in cases of Reumathoid Arthritis with 1 or more risk
factors for Gastric Ulcer.

The problem appears when it is used in an illegal way to produce abortion in
cases of non desidered pregnancies. Though it is a combination that must be
sold only with medical prescription, sometimes it's easy to convince the
physcian or pharmacist with no escrupules about prescribing it.
I hope you are understanding what I'm meaning.
Now, my questions are, and I should like you to help me with this:

a) Is there an association like this in your countries?

b) If the previous answer is positive: Which are the legal restrictions?

c) Is there a really necessity for this combination, or there is other
solution to minimize gastrointestinal AE of NSAIDs?

d)Do you know about the illegal use of htis drug in your counties,  i.e. as
an abortifacient?

Thanks you all for your attention.
Hoping for your answers, yours,

Edith Elizabeth Delvechio
Pharmaceutical Drug Information Centre
College of Pharmacists of the Province of Buenos Aires
ARGENTINA
Email: cimf@colfarma.org.ar

[moderator's comment: misoprostol is known to be an effective cervix-ripening drug, and is
used in many countries (where abortion is legal) in treatment protocols for abortion. 
Obviously, the combination with diclofenac should be avoided in those cases, as only 
misoprostol is needed.
Indeed, misoprostol risks to be misused by doctors and desperate women in countries where
abortion is not (yet) legal. But the drug is effective and can be used safely if 
used under medical supervision.
The drug company involved is not happy about the misuse, and does not actively seek
an indication as cervix ripening agent. 
Misoprostol is also reported to lead to congenital malformations if the abortion attempt
is not succesfull. 
In my personal view, the problem needs to be resolved in legalising abortion rather than
withdrawing the drug. 
Prescription controls are indeed not very effective; what can we do about that?
As to whether a fixed dose combination of diclofenac with misoprostol is needed: let's
get the evidence for that. Anybody?
Wilbert Bannenberg, acting moderator
WilbertBannenberg@compuserve.com
]

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