Additional resources for Cytotec information include:


Package Insert

http://www.fda.gov/cder/foi/label/2002/19268slr037.pdf

Dear Doctor Letter from Searle

http://www.fda.gov/medwatch/safety/2000/cytote.htm

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."


Midwife Archives

The Midwife Archives is a collection of information about all aspects of pregnancy, birth and well-woman care from a midwifery perspective. 

http://www.gentlebirth.org/archives/cytotec.html


Misoprostol (Cytotec) for Labor Induction: A Cautionary Tale

by Marsden Wagner, MD, MSPH

http://www.midwiferytoday.com/articles/cytotecwagner.asp

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.

http://www.midwiferytoday.com/articles/cytotec.asp

"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

http://www.whatisaids.com/cytotec107.htm

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, May/June 2003.


Cytotec for Labor Induction Consumer Awareness

http://www.petitiononline.com/cytotec/petition.html

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 its use.


 

Uterine Ruptures Associated with Prostaglandin Used with RU486
By Randall K. O'Bannon, Ph.D., NRL-ETF Director of Education & Research

National Right to Life

http://www.nrlc.org/news/2001/NRL01/randy.html

When the 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) last September.

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)

http://www.aimsusa.org/ObstetricDrugs-NotApproved.htm

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 Physicians

http://www.aafp.org/afp/20000715/practice.html

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.

http://www.midwiferytoday.com/cytotec/


Yahoo Support Group

Category: Pregnancy and Birth

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: Meghanswish-subscribe@yahoogroups.com You will find support and healing there.

 Group Email Addresses
Post message: cytotec@yahoogroups.com
Subscribe: cytotec-subscribe@yahoogroups.com
Unsubscribe: cytotec-unsubscribe@yahoogroups.com
List owner: cytotec-owner@yahoogroups.com

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