WOMENS-HEALTH Messages for September, 2000: Re: The truth about Cytotec...

Re: The truth about Cytotec...

From: Kelly Shanahan, MD (anonymous@obgyn.net)
Sat, 2 Sep 2000 01:22:05 -0500 (CDT)

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In reply to: S: "The truth about Cytotec..."
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At Fri, 1 Sep 2000, S wrote: >
>I am posting this because I am concerned as a woman, about the health of
>other women and not getting the true information on the dangers of
>inductions with Cytotec. We all need to know what we are not being
>told! I cannot post my name because I work in the medical field myself
>and fear reprocussions from this. Recently, Searle send a letter to
>ob/gyns across the country on the dangers of the off-label use of this
>drug. It is becoming more widely used and does NOT have FDA approval
>for use for induction. It had been linked to uterine rupture for women
>with both scarred and unscarred uteri. Perhaps Searle has written this
>to protect themselves from lawsuits, but then one has to ask, why are
>they so worried if this is safe? This is the letter:
>
>August 23, 2000
>
> IMPORTANT DRUG WARNING
> CONCERNING UNAPPROVED USE OF INTRAVAGINAL
> OR ORAL MISOPROSTOL IN PREGNANT WOMEN
> FOR INDUCTION OF LABOR OR ABORTION
> Dear Health Care Provider:
>
>The purpose of this letter is to remind you that Cytotec administration
>by any route is contraindicated in women who are pregnant because it can
> cause abortion. Cytotec is not approved for the induction of labor or
> abortion.
>
> Cytotec is indicated for the prevention of NSAID (nonsteroidal
> anti-inflammatory drugs, including aspirin)-induced gastric ulcers in
> patients at high risk of complications from gastric ulcer, e.g., the
> elderly and patients with concomitant debilitating disease, as well as
>patients at high risk of developing gastric ulceration, such as patients
> with a history of ulcer.
>
> The uterotonic effect of Cytotec is an inherent property of
> prostaglandin E1(PGE1), of which Cytotec is stable, orally active,
> synthetic analog. Searle has become aware of some instances where
> Cytotec, outside of its approved indication, was used as a cervical
> ripening agent prior to termination of pregnancy, or for induction of
> labor, in spite of the specific contraindications to its use during
> pregnancy.
>
>--
> Serious adverse events reported following off-label use of Cytotec in
> pregnant women include maternal or fetal death; uterine
> hyperstimulation, rupture or perforation requiring uterine surgical
>repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism;
>severe vaginal bleeding, retained placenta, shock, fetal bradycardia and
> pelvic pain.
>
> Searle has not conducted research concerning the use of Cytotec for
>cervical ripening prior to termination of pregnancy or for induction of
>labor, nor does Searle intend to study or support these uses. Therefore,
> Searle is unable to provide complete risk information for Cytotec when
> it is used for such purposes. In addition to the known and unknown
>acute risks to the mother and fetus, the effect of Cytotec on the later
>growth, development and functional maturation of the child when Cytotec
> is used for induction of labor or cervical ripening has not been
> established.
>
> Searle promotes the use of Cytotec only for its approved indication.
> Please read the enclosed updated complete Prescribing Information for
> Cytotec.
>
> Further information may be obtained by calling 1-800-323-4204.
>
> Michael Cullen, MD
> Medical Director, U.S.
> Searle
>

Anything used improperly has the potential for harm -- too many Big Macs can make you fat and contribute to high blood pressure and you can have a heart attack and die. Half the things we use in medicine (especially in ob) are off albel uses.

Cytotec has a place in hte induction of labor -- and it has great potential for misuse. Informed consent should be given, and your doctor must be aware of hte potential benefits and risks and the literature to support this -- and inform you of it.

Properlyy selected patients receiving Cytotec in the proper dose, with the proper monitoring do very well for hte most part. Yes uterine rupture may happen, but it can happen in spontaneously occuring labor as well.

Ask questions. Get all the info youu need to make a decision. But don't throw the baby out with the bathwater.

--
M. Kelly Shanahan, MD, FACOG
South Lake Tahoe, CA

This information is for educational purposes only and does not construe a doctor-patient relationship. It does not replace the need for you to consult your own doctor.

***private e-mails will be deleted without reading. Please respect my family time

Next message: Kelly Shanahan, MD: "Re: complete loss of libido on depo-provera"
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In reply to: S: "The truth about Cytotec..."
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