Call to Action: Childbirth Organizations and Childbirth Advocates, Doulas, Midwives, Health Care Providers
RE: Off Label Use of Cytotec for Inducing Labor
ACOG has pushed the off label use of Cytotec (Misoprostol) for inducing labor for over 13 years. During that time countless babies and mothers have been permanently damaged, suffered uterine rupture, amniotic fluid embolisms; many mothers and babies have died within hours of a Cytotec induction. In Sept of
2007, through the Freedom of Information Act, the Tatia Oden French Memorial Foundation requested the FDA to supply the Medwatch Forms they received for the time period Jan. 2001 through Sept. 2007, dealing with the adverse events occurring from the use of Cytotec. We received a file containing 1746 records of adverse events. Three hundred and fifty (350), 20% of these adverse events were the result of cytotec being used to induce labor. In 2004, the Tatia Oden French Memorial Foundation submitted a petition to the FDA containing 1,000 signatures, requesting the FDA to produce a medicine guide on the use of Cytotec for inducing labor showing all the adverse events that can occur. The petition has remained online and now has an additional 1,963 signatures, many with comments about mothers, wives, friends, who have lost their lives, or the baby’s life, had uterine rupture, amniotic fluid embolisms, or resulted in the baby being permanently brain damaged. Our petition remains open on the dockets of the FDA. While the FDA has issued an alert on the use of Cytotec for inducing labor, it
has not brought this alert to the media for widespread dissemination. This is NOT enough. In recent months the FDA has withdrawn many previously approved drugs from the market due to adverse events, including the possibility of death.
Because Cytotec is used off label to induce labor, the FDA has no authority to withdraw it from the market. It does however, have the authority to issue a public warning on possible adverse effects from its off label use. Adverse and catastrophic events caused by a drug are no less catastrophic if caused by a drug that has NOT been approved for a particular indication. The difference lies in the amount of information a patient/client has regarding the possible side effects and risks BEFORE they consent to use the drug. The public has a right to be informed of these side effects. The FDA has a responsibility to inform the
public of adverse effects. As health care professionals, doulas, midwives, women, families and friends of women who have been victimized and harmed by the off label use of Cytotec when used to induce labor, WE are alerting the public to the adverse events which can occur when Cytotec (Misoprostol) is used to induce labor. Please read very carefully the attached link, which contains the letter, sent to over 200,000 physicians in Aug of 2000, by Searle, the manufacturer of Cytotec. The letter clearly warns of the dangers this drug will have if used for labor induction. The letter specifically states, Cytotec should NOT be given to pregnant women. These tremendously tragic events are
unnecessary. The off label use of Cytotec to induce labor must be stopped. There are other interventions, which can and are used to induce labor. It is up to us to spread the word to the public, to health care providers, to all women of childbearing age: DO NOT USE CYTOTEC TO INDUCE LABOR.
Sincerely,
Maddy Oden Maddy Oden, Chair The Tatia Oden French Memorial Foundation
Click here to read the letter from Searle.
Wednesday, February 20, 2008
Call to Action
This is an email I was forwarded. Cytotec is dangerous when used to induce moms! Pass this along to everyone you know and help get the word out!
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6 comments:
hey shelly-thanx for visiting:) i read about cytotec in doula studies. i'll never understand why they even started using it the way they have. i think partof it is all about money, it's cheaper. thanx for posting this. i've started posts about cytotec, but never finished them b/c there is just so much to it that i never felt like i could put it together well enough and come o/ doing it justice....
ok me again, i was just reading on down your blog here, you sell arbonne? i use it! i found it a couple of years ago when a friend started selling it. it's really the best stuff o/ there imho...
Just wanna say hi to you shelly.. :-)
:-)
I heard about this recently- scary!
Steph
I tagged you :)
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