Dear Doctor Letter from Searle
FDA documentation including the retyped text of a "Dear Doctor"
letter from Searle released on August 23, 2000, stating: "Cytotec is not approved for the induction of labor or abortion."
The Midwife Archives is a collection of information about all aspects of
pregnancy, birth and well-woman care from a midwifery perspective.
Misoprostol (Cytotec) for Labor
Induction: A Cautionary Tale
by Marsden Wagner, MD, MSPH
© 1999 Midwifery Today, Inc. All Rights Reserved.
Marsden Wagner, MD, is a neonatologist and perinatal epidemiologist. He was
responsible for maternal and child health in the European Regional Office of the
World Health Organization for 14 years. Now living in Washington, D.C., he
travels the world talking about appropriate uses of technology in birth and
utilizing midwives for the best outcome.
Cytotec Induction and Off-Label Use
by Marsden Wagner, MD, MS
© Midwifery Today Issue
67, Fall 2003. All Rights Reserved.
"Without adequate testing of Cytotec (misoprostol) for labor induction,
obstetricians simply began to use it on their birthing women. They were taking
advantage of a huge loophole in our drug regulatory system. Once a drug is
approved by the FDA for a specific medical indication and put on the market,
there is absolutely nothing to prevent any doctor from using that drug for any
indication, in any dose, for any patient he or she chooses. Since the label of
the drug contains the indications approved by the FDA, this is called
"off-label" use of a drug.
When obstetricians using Cytotec induction are confronted about their
willingness to use a drug "off-label," they inevitably answer:
"We use drugs off-label all the time." There are several serious
problems with this answer. First, in reality, using Cytotec for induction is not
"off-label" at all—it is "on-label contraindicated." On
the Cytotec label it is explicitly written that this drug is contraindicated for
use on pregnant women. Contraindication would not be on the label unless data
exist suggesting possible serious risks from such use. "On-label
contraindicated" is a whole different level of risk-taking than a use that
is not mentioned one way or the other on the label."
Induced and Seduced: The Dangers of Cytotec
Issue 107, July/August 2001
By Ina May Gaskin
A review of an adverse outcome due to the use of Cytotec for cervical
ripening and a summary of other related Cytotec issues in Mothering
magazine, Issue #118,
Cytotec for Labor
Induction Consumer Awareness
The Tatia M. French Oden
Foundation is organizing a consumer group which is petitioning the FDA because
of adverse events with the use of G.D. Searle’s (now Pharmacia) drug Cytotec, (Misoprostol)
for cervical ripening or labor induction. The Board and employees of this
Foundation as well as signatories to this petition are people who are related to
or have friends (as well as their babies) who died because of the misuse of this
product, and some of them were given the drug, with no warning information about
Uterine Ruptures Associated with Prostaglandin Used
By Randall K. O'Bannon, Ph.D., NRL-ETF Director
of Education & Research
National Right to Life
manufacturer of the anti-ulcer drug Cytotec released a letter August 23, 2000,
to warn doctors of injuries associated with unsanctioned ["off-label"]
obstetrical uses of the drug, the pro-abortion American College of Obstetricians
and Gynecologists (ACOG) publicly questioned the "content, timing, and
tone" of G.D. Searle's letter.
What upset ACOG was its fear that Searle's letter could "limit the use of
this new option for reproductive choice" (ACOG Letter, 10/26/00). ACOG was
concerned that Searle's letter might have an impact on doctors or hospitals
considering the use of Cytotec in conjunction with the abortion pill RU486,
which received marketing approval from the Food and Drug Administration (FDA)
Contrary to the implications of ACOG's letter, however, Searle's letter was
prompted by reports of uterine ruptures that the company had received associated
with some off-label uses of its drug. Searle specifically addressed Cytotec's
off-label use as a cervical ripener, labor inducer, or a stand-alone
abortifacient. Now, independent evidence has surfaced that Searle's concerns
about Cytotec's use as a labor inducer were amply justified. . . .
Alliance for the Improvement of
Maternity Services (AIMS)
DRUGS NOT FDA APPROVED FOR OBSTETRICS
This link takes you to a partial list of drugs sometimes used off-label in
obstetric care, which have NOT been approved by the FDA for such use. There have been no adequate and
well-controlled studies to determine the delayed, long-term effects of the drugs
listed on this site on pregnant women or on the neurologic, as well as general,
development of children exposed to the drugs in utero or during lactation. Such
use is defined by the FDA as "off-label" use.
American Academy of Family
This linked excerpt provides access to the summary of recommendations at
the end of the 10-page ACOG report as a means of communicating the
"Standard of Care" to Family Physicians, who are performing more and
more deliveries in recent years.
They wrote: "The Committee on Practice BulletinsObstetrics of
the American College of Obstetricians and Gynecologists (ACOG) has issued new
clinical management guidelines on the induction of labor. ACOG Technical
Bulletin No. 10, which replaces Technical Bulletin No. 217 issued in December
1995, appears in the November 1999 issue of Obstetrics and Gynecology.
The report reviews the current methods of cervical ripening and induction of
labor and summarizes the effectiveness of each method on the basis of outcomes
research. It also contains a question-and-answer section that covers the
following information: the indications for and contraindications to induction of
labor; the relative effectiveness of pharmacologic agents for cervical ripening;
administration of prostaglandin; the potential complications associated with
each method of cervical ripening and labor induction; guidelines for fetal
monitoring; the dosage of oxytocin and precautions to take when this agent is
used; the management of complications from the use of oxytocin; the
applicability of the various methods of labor induction in patients with intact
or ruptured membranes; labor induction in cases of intrauterine fetal demise in
the late second or third trimester; and the cost-effectiveness of misoprostol
(synthetic prostaglandin E1 analog) and
dinoprostone (prostaglandin E2[PGE2])."
Cytotec and Drugs in Labor
Learn about the effects of drugs used during labor and other interventions.
Yahoo Support Group
This group is for women who have been given Cytotec/Misoprostal (a cervical
ripening drug for induction purposes) If you have been given this drug and had a
bad outcome, i.e. uterine rupture, loss of your baby, or brain damaged baby,
please join us. Doctors, nurses, midwives and doulas are welcome to join this
forum. For uterine rupture support, send an email to: Meghanswishemail@example.com
You will find support and healing there.
Legal Services by professionals with special expertise and interest in
Cytotec and Obstetric Negligence