Re: Cytotec
From: Efrain Ramirez (eramirezt@coqui.net)
Fri May 12 06:35:46 2006
Gail - the world literature is full of artcles of misprostol fr the
induction of labor.. it's inexpensive - stable - easy storage, widely
available, effective, safe and cheap.. I agree with Stephen that the
margin of safety is a bit narrow - and IMHO - it is not as "predictable"
as Prostin gel..
Here is ACOG's response to Searle -
Committee
Opinion
[PDF format]
--------------------------------------------------------------------------------
Number 283, May 2003
--------------------------------------------------------------------------------
--
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
New U.S. Food and Drug Administration Labeling on Cytotec (Misoprostol)
--------------------------------------------------------------------------------
Use and Pregnancy
--------------------------------------------------------------------------------
ABSTRACT: On April 17, 2002, the U.S. Food and Drug Administration
approved a new label for the use of Cytotec (misoprostol) during
pregnancy. The new labeling does not contain claims regarding the
efficacy and/or safety of Cytotec when it is used for cervical ripening
for the induction of labor nor does it stipulate doses or dosing
intervals. Therefore, the Committee on Obstetric Practice reminds
Fellows that this agent should be used as previously recommended.
On April 17, 2002, the U.S. Food and Drug Administration (FDA) approved
a new label for the use of Cytotec (misoprostol) during pregnancy. The
FDA describes the major labeling changes and their rationale as follows
(see also the FDA's web site at
http://www.fda.gov/medwatch/safety/2002/safety02.htm#cytote). The new
labeling:
Revises the contraindication and precaution that Cytotec should not be
used in women who are pregnant by stating that the contraindication is
for pregnant women who are using Cytotec to reduce the risk of
nonsteroidal antiinflammatory drug (NSAID)-induced stomach ulcers.
— Rationale—The drug has a recognized use by ob-gyns to induce labor,
delivery, and is part of the FDA-approved regimen for use with
mifepristone to induce abortion in pregnancies of 49 days or less. The
contraindication now refers to the drug's approved indication, for
reducing the risk of NSAID-induced gastric ulcers.
Creates a new labor and delivery section of the labeling and provides
safety information related to those uses.
— Rationale—21 CFR 201.57(f)(7) requires labeling to include drug-effect
information if a drug has a recognized use during labor or delivery,
whether or not the use is stated in the indications section of the
labeling.
Provides new information that uterine rupture, an adverse event reported
with Cytotec, is associated with risk factors such as later trimester
pregnancies, higher doses of the drug, including the manufactured
100-mcg tablets, prior cesarean delivery or uterine surgery, and having
had five or more previous pregnancies.
— Rationale—Risk factors allow physicians to identify patients who may
be at greater risk for these adverse events. This information may guide
safer use of the drug.
The new labeling does not contain claims regarding the efficacy and/or
safety of Cytotec when it is used for cervical ripening for the
induction of labor nor does it stipulate doses or dosing intervals.
Therefore, the Committee on Obstetric Practice reminds Fellows that this
agent should be used as previously recommended (see box) (1–3).
Recommended Uses of Cytotec
If misoprostol is to be used for cervical ripening or labor induction in
the third trimester, one quarter of a 100-µg tablet (ie, approximately
25 µg) should be considered for the initial dose. The use of higher
doses (50 µg every 6 hours) may be appropriate in some situations,
although increasing the dose appears to be associated with uterine
tachysystole and possibly with uterine hyperstimulation and meconium
staining of amniotic fluid.
Doses should not be administered more frequently than every 3–6 hours.
Oxytocin should not be administered less than 4 hours after the last
misoprostol dose.
Patients undergoing cervical ripening or labor induction with
misoprostol for labor induction should undergo fetal heart rate and
uterine activity monitoring in a hospital setting.
Misoprostol should not be used for cervical ripening for the induction
of labor in patients with a previous cesarean delivery or prior major
uterine surgery.
References
American College of Obstetricians and Gynecologists. Induction of labor
with misoprostol. ACOG Committee Opinion 228. Washington, DC: ACOG;
1999.
American College of Obstetricians and Gynecologists. Response to
Searle's drug warning on misoprostol. ACOG Committee Opinion 248.
Washington, DC: ACOG; 2000.
American College of Obstetricians and Gynecologists. Induction of
labor. ACOG Practice Bulletin 10. Washington, DC: ACOG; 1999.
At Fri, 12 May 2006, GA12L@aol.com wrote:
>
>I'm sorry, but I don't understand why Cytotec is used to induce labour.
>Pharmacia Limited who market Cytotec here clearly state that
>
>"Cytotec is contraindicated in pregnant women and in women planning a
>pregnancy as it increases uterine tone and contractions in pregnancy which may
>cause partial or complete expulsion of the products of conception. Use in
>pregnancy has been associated with birth defects."
>
>Cytotec is indicated for the healing of duodenal ulcer and gastric ulcer
>including those induced by nonsteroidal anti-inflammatory drugs (NSAID) in
>arthritic patients at risk, whilst continuing their NSAID therapy. In addition,
>Cytotec can be used for the prophylaxis of NSAID-induced ulcers. It says nothing
> about using it to induce labour in fact Pharmacia says that when used in
>pre-menopausal women they should ensure that they have adequate contraception.
>The Summary of Product Characteristics (SPC) clearly says in the section
>Undesirable effects
>"A number of side effects have been reported in clinical studies or in the
>literature following use of misoprostol for non-approved indications. These
>include abnormal uterine contractions, uterine haemorrhage, retained placenta,
>amniotic fluid embolism, incomplete abortion and premature birth."
>So using Cytoec for inducing labour is a) using it for a non-approved
>indication and b) it CAN cause AFE.
>So why is it used to induce labour? Sorry, I don't understand but I'm sure
>one of you will enlighten me!
>Gail
--
“ The greatest obstacle to knowledge is not ignorance,
it is the illusion of knowledge.” Daniel J. Boorstin - Historian
