Wednesday, January 11, 2012

Cytotec - JUST SAY NO.

The following is from an article by Dr. Marsden Wagner, author of the fantastic book Born in the USA: How a Broken Maternity System Must Be Fixed to Put Women and Children First.


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.

Have you ever looked at the label of a Cytotec bottle? There is a GIANT picture of a pregnant woman with a circle and slash through it. That's the universal symbol for DO NOT.  Don't believe me?



The makers of Cytotec have begged - begged OBs to stop using this drug because of frequent catastrophic outcome for mothers and neonates.

Marsden continues: (emphasis mine)

 Those doctors and midwives using Cytotec for induction of labor off-label need to understand that they are taking very big chances with the safety of the women and babies they serve. Just about everyone in the world, after taking a careful look at the scientific evidence, has concluded we don't yet know enough about the risks to be willing to use it. This is illustrated in the following list of organizations that do and do not recommend Cytotec (misoprostol) for labor induction:

Recommends
  1. American College of Obstetricians and Gynecologists (ACOG)
Well whoop dee freakin do. ACOG.
    Does not recommend
    1. U.S. Food and Drug Administration
    2. Best scientific opinion—Cochrane Database
    3. Searle (manufacturer of Cytotec)
    4. Society of Obstetricians and Gynaecologists of Canada
    5. British Royal College of Obstetricians and Gynecologists
    6. All obstetric organizations in Scandinavia
    7. FIGO (International Federation of Gynecology and Obstetrics)
    8. World Health Organization
    9. Obstetric organizations and drug regulatory agencies in many other countries

    So why do OBs in the US insist on using Cytotec for labor induction knowing its dangers? Well, a dose of Cytotec costs $10. A dose of Pitocin costs $100. You do the math. They are risking the lives of mothers and babies for $90. Read Marsden's entire article here.  

    As long as surgeons can get away with this, they will.  This should shock you. This should enrage you.

    Finally, in memory of those who died. Read on for the chilling comments from an online petition to stop this madness. Advice? Get some Kleenex.



    Regina L Moran
    My daughter was given Cytotec to iduce labor. She was not warned of the adverse effects, from taking it. She now suffers from much pain, Caused but the horricfic pressusure pressure put on her brain from having one long contaction that wouldnt end, with the urge to push. She is on heavy medication for the pain. And her 2 daughters now have a Mom that isnt able to be the mom she was before the second baby was borm. Shortly after giving birth she began to have bad pain. Karie Malformation is asymtomatic, unles something causes too much pressure on the brain. Like the strain of pushing in labor., with a contraction that wont let up. She now needs surgery to fix it.. I pray that that OB's and midwives will not have acces to this drug, that has already caused the deaths of so many mothers, and their baby.

    101.
    Melba Reimer
    I used cytotec in labor, my daughter had a seizure the day after.

    139.
    Cindy Ellingson
    My son died as a result of my uterus literally blowing up during the last phase of pushing.

    141.
    Scott Ellingson
    I held my son in my arms while he was taken off life support, thanks to Cytotec.

    153.
    Erin Moore
    Cytotec almost killed me during labor...


    205.
    Gwen L Barnett
    The drug caused terrible complications for my daughter and could have caused her death

    210.
    Melanie Anne Harding
    My daughter Jessica Nicole Harding ,was left disabled after the use of Cytotec to induce my labor, my labor was TOO quick and caused her to be without oxygen, she died 7months 5days later, due to the damage on her brain, on Christmas Day 2002. I have suffered very badly due to trusting that this drug would be safe to use, instead I have to live with the pain , of one terrible choice, for the rest of my life.

    220.
    Shen Young
    In memory of my daughter Karley who died after I received 3 doses of this horrible drug. I trusted my OB and would never have allowed the use of Cytotec had I known it's fatal side effects.

    251.
    Melissa Emerine
    Due to Cytotec, my uterus completely blew up and tore in all directions. My daughter was thrown into my abdomen and was cut off from oxygen. My beautiful daughter has cerebral palsy and seiures. Cytotec should not be used to induce pregnant women. Cytotec was designed to aid digestion for gastric ulcers. Now this drug has moved on as an "off-label" drug to combine with the RU486 drug to complete abortions. Doctors were lead to believe that this "off-label" drug could aid in ripening a woman's cervix, even though Searle, its manufacturer warned against its use on pregnant women. Cytotec is a political pill that is hard to swallow! Please act now and ban this drug from being used on full term pregant women before we lose yet another beautiful mother and baby.

    254.
    Kourtney Harper
    I watched my wife almost bleed to death after her uterus ruptured. Please stop this!

    258.
    Rebecca Manning
    This drug is dangerous and should never be used for labor induction. My friend almost bled to death due to administration of this drug without being told of the contraindications!!

    274.
    Chuck Heineman
    My wife and daughter both almost died due the use of labor induction drugs

    276.
    Arlene Matejka
    The Birth Story of Emily Faith, Uterine Rupture Survivor http://www.birthlove.com/free/emily_faith.html

    297.
    ANNE BOYLE
    My daughter and granddaughter almost died

    301.
    Tracy Lynn Hamilton
    I was given Cytotec without knowing any of the side effects. Luckily my child and I lived but, my uterus did tear at the lowest segment into my cervix. My OB lied to me and I recently found out and I am very upset. I later found out that a young lady died by the hands of this doctor one week after I gave birth to my daughter, Lauryn. We have GOT to do something about this. Tatia and her daughter died a senseless death and the manufacturer of these drugs and the doctors using these drugs need to be penalized and some form of reprimandation needs to take place. I am so very, very angry! They are taking our rights of empowerment of our birthing plan away for their own benefits. (Doctors) I am sickened by this and these doctors need to lose their lisense as well.

    309.
    Maia McKinney
    She was and still is my best friend and I miss her terribly. She and Zorah were stolen from us.




    328.
    Mary Brownlow
    Friend's uterus ruptured and baby died d/t Cytotec

    346.
    bertha mear
    i believ i was given cytotec i wento the hospital at 10 am by 5pm i hd arupured uteris and a dieing baby was aperfect baby she strangeled on my blood . i lost 3or 4 pints of blood i almost died and the next day my perfect darling child died , because my doctor had a tee time he did not want to miss. i am broken hearted . i came home from the hospital 2 weeks later with empy arms . the nine months i waited for my baby was for nothing i never even got to see herface. empty arms and a broken heart. so uncalled for . i understand the sorrow of all those poor women who have suffered as i have. i hope there is more control over the use of this dangerous drug. God bless allthe broken hearted mothers who have gone thru what i have.

    356.
    Lisa M. Davis
    I to also had a horrible childbirth and way to many intervention, and went into Eclampsia and almost went into acomma, I hope something is doen about all these drug's these use.

    373.
    Joyce A. Vanselow
    I witnessed labor during which this product was utilized and I feel that there is not enough info provided to consumers. In fact this woman was told not to tell anyone or the hospital could be in trouble. This is NOT right. The labor was not helped by using this product either, and ended in Cesarian Section. Breastfeeding could not be initiated, and bonding was not what it could have been. I do not see any advantage in this product's use and in fact felt that it was a detriment ultimately. I am a postpartum doula trainee with CAPPA.





    393.
    Christy Andrews, CLD, CLE, CHBE
    I had uterine hyperstimulation and fetal oxygen deprivation from this tiny pill my nurse promised was "generic Cervadil". How many more women and babies will suffer before the FDA does it's job and protects consumers from unscrupulous use of dangerous drugs?

    427.
    Jennifer Wrampe
    I was given this drug to induce labor because my daughter was "getting to big". This was my first child and I trusted my doctor. He did not tell me about any side effects of this drug. My daughter was born perfectly healthy, but I almost bled to death and had to have a hystorectomy.

    479.
    Duane J. Brescia
    Please do something about this injustice. "Everyone else is using it" is not an excuse. Debilitating and permanent injuries to my wife with a previous UNSCARRED uterus.

    509.
    Kelly Fisk
    Cytotec was the first step on my road to a C Section!

    574.
    Melissa Harley CD(DONA), LCCE
    I was given this drug for the birth of my son in 1999. I had no idea of anything negative associated with this drug. This drug caused hyper stimulation of the uterus and I thought that I was going to die because of the unbearable pain. I'm thankful for our health, but angry that this drug was used without proper testing/approval.

    631.
    Hansi Holloway
    In memory of my son Ronald Andrew Holloway born 2/2/2005 and died on 2/9/2005 after I was given Cytotec to induce my labor but was NOT told or warned in ANY way. GOD bless those of us who have suffered at the hands of vigilantly medical provides. Andrew’s website is www.thecloudwalker.net/and
    rew

    645.
    Erin M. Freiberg
    One of my friends was forced to have an emergency hysterectomy after amniotic fluid embollism as a result of cytotec. She nearly died in labor. This drug should be banned for use in the induction of live births.

    694.
    Sheri Dabney
    In 2002 I was given Cytotec to induce labor and ended up nearly dying. I had to have an emergency hysterectomy and spent several days in the ICU. This was my first child and I was only 26. I am thankful everyday that my son was born healthy! The diagnosis was amniotic fluid embolism, but I was not told that Cytotec was most likely the culprit.

    701.
    Mrs Susan Pottberg
    My niece had a ruptured uterus from this medication, and had to have a hysterectomy after delivering her son by an emergency c-section. We were lucky we didn't loose both of them during this emergency! Because of this, they can't have any more children!

    706.
    liz froneberger, rn
    a friend of mine required over 25 units of blood after getting this medication -- she and the baby almost died.

    747.
    Donna Hamlin
    The doctors gave us none to very little hope, after my sister was life flighted to another hospital to treat her critical condition from the effects of having her labor induced with Cytotec - it is tragic and most often than not - FATAL !!



    754.
    Tina Robinson
    my baby died 3 weeks ago because of this drug. I almost died too. I had a uterine rupture.

    763.
    Kendra Shaw
    I was given cytotec and almost lost my baby and my life.

    767.
    Denise Rick
    My son had a hemmorage in his brain due to Cytotec

    823.
    shante powders
    A personal friend lost baby due to this drug

    1671.
    Jacqueline Martinez
    My child died in result of a cervical ripening agent. He was a beautiful, 9# and 5ounces. Had a good strong heartbeat up until the cervical was given.

    1692.
    Gina Dockery
    My nephew has Cerebral Palsy due to the use of Cytotec to induce labor

    1723.
    Kellee Wolfe
    I suffered a severe uterine rupture had to have an emergency hysterectomy and almost died. I didn't know the side effect of this drug when given. Thank God my baby is healthy.

    1820.
    Pamela Carman
    My grandson died because of Cytotec. I nearly lost my daughter as well. The attending physician never told my daughter that he was giving her this dangerous drug. After my grandson was delivered brain dead, the doctor remained quiet about the part he played in this tragedy. We learned, after it was too late, about Cytotec and the part it played in Andrew's death. It was months later that we learned, to our surprise and horror, that doctors can use a drug any way they want to once the drug has been approved by the FDA for some other purpose. Had my daughter been informed of what she was being given, and the possible consequences, she would never have taken Cytotec and our grandson would be alive today.

    1843.
    Misty Ann Prescott
    I lost my precious baby at 2wks in 2005 after a cytotec induction gone wrong I nearly lost my own life.

    1880.
    Chesnye Steward
    I was given this with my son in 2001. We almost lost him and had many months of health issues related to this drug. I was not informed about ANY side effects.

    1890.
    Jennifer Ligman
    I never would have allowed the use of Cytotec to induce my labor, had I known all the risks associated with it. This drug led me to get a hysterectomy after the birth of my only child, a stillborn daughter. I am only 25 years old.

    1914.
    christie smith
    harmed by Cytotec

    1915.
    Miranda Gray-Burlingame
    I had AFE after receiving cytotec in 2002.

    1922.
    Russell Paul
    Just lost my grandaughter due to hyper stimulation caused by cytotec.


    1924.
    Janet Kervick
    in 2006 I was unknowingly given Cytotec during labor and nearly died.

    1932.
    Mark Litkowski
    My wife died 1 hour after giving birth 4 Nov 2004

    1941.
    Marti Runkwitz
    I was induced with 2 doses of cytotec in conjunction with cervadil and experienced uterine rupture. My son was without oxygen for 7 minutes and has cerebral palsy. I was told I must have had a congenital defect...you can draw your own conclusions. I sincerely hope this never happens to another mother and child.

    1958.
    Debby Thompson
    My friend just lost her baby girl to cytotec, she almost died and spent a week in hospital fighting for her life. She can no longer have children.

    963.
    Torie Myers
    An extremely high dosage of Cytotec was administered without my knowledge and informed consent. As a result my baby was aborted and I could have died as well.

    2002.
    Tara L. Morris
    My sister died April 22, 2008 from an amniotic fluid embolism after receiving Cytotec. Her name was Wendy Bassett and she was a beautiful person.

    1968.
    Jenne Alderks
    Its the gross misuse of Cytotec that inspired my poem "I Came Out with A Baby" (http://descentintomotherhood.blogspot.com/2008/02/i-came-out-with-baby.html) where modern maternity care is compared to a Nazi Germany concentration camp. Tragically, Tatia and her sweet baby did not leave the hospital alive. I pray that misuse will be stopped.



    1996.
    Jen Ambrico-Boyce
    i was given this drug and had severe bleeding and blood clots during labor. when asked of why all the bleeding was happening-their reply was-i don't know. my son had aspirated on my blood. he didn't cry-he was limp and dazed. he was quickly taken from me and put in the nicu. he was given antibiotics and hooked up to many machines including an iv.he stayed in the incubator for over 24 hours.he got a little better then got worse.no more food just iv fluids. then he pulled out of it and we could hold him and feed him .they did x-rays of his chest and tests-which we thought to be blood tests to rule out infection .after 3 days we went home -together. this by the way was my fifth baby and my first time ever having cytotec. thank you for letting people share a little something.

    1998.
    Hope Beisinger
    We nearly lost our daughter and granddaughter in 2001 from the misuse of Cytotec. Our daughter was never told of the dangers of using Cytotec for induction of labor. She had Cytotec inserted in her vagina after about five hours into the induction. During the labor process the doctors changed shifts. Her regular doctor came on the scene at that time so that doctor knew of the dangers of Cytotec with uterus surgeries. (The first doc inserted the Cytotec. Our daughter had a tumor removed from the back of her uterus in 1993 and several procedures done to her cervix.) After several hours of very hard labor the delivery began. Our daughter had hard, heavy bleeding with very large blood clots, her uterus ruptured, and her first-born child, a girl, was not breathing! Our granddaughter spent thirteen days in the nic unit hooked up to tubes, wires, and monitors. She came home with a feeding tube and a monitor that would alert us if she stopped breathing. After several months our granddaughter was diagnosed
    with Cerebral Palsy and Epilepsy. She was denied oxygen during her birth. She is now six years old and is very beautiful. She has big brown eyes, natural curly blonds hair, and a smile that will melt your heart!

    2021.
    Tyler White
    My wife was given Cytotec to induce labor and had adverse effects from it.


    2032.
    Paris Cho
    cytotec almost killed my friend

    2071.
    Tara Yvette Potter
    I nearly died at Mayo after being dosed most emphatically against my will.

    2100.
    Dawn Hawthorne
    I just had a baby 5 weeks ago. Cytotec caused hyperstimulation causing my baby's heart to drop from down to the 60s. I was given cytotec at 8:45 and delivered at 10:00 and was scheduled for an emergency c-section but delivered to quick. How can we stop the use of this drug to induce labor. Please do something quickly before more babies and women die. Please Please Please!!!!!!!

    2102.
    Margaret Ostervold
    When I was induced 8 months ago for "post-date", I was asked to sign a blanket consent for induction prior. I had NO IDEA that the drug I was being induced with was being used not just "off-label", but actually "against-label"! I would have NEVER consented to administration of a drug that specifically states that it is not to be used for induction. I had contractions coming too quick and my baby was having heart rate problems with decelleration. I was horrified to learn the facts about misoprostol 6 months after it was used on me, and I am very thankful that my baby girl and I are both ok. I am so sorry for those who were not so lucky. Please do something to end the against label use of this ulcer drug."

    6 comments:

    Mary said...

    THANK YOU for posting this!!! I am going to share!!!
    I'm so glad I was super-educated about all of this! So scary to put your lives in the doctors hands.

    Beth said...

    Horrible!!!!

    C.C. (aka Crunchy Catholic Mama) said...

    Amen! I pray that people will start listening.

    Joy Beyond the Cross said...

    I had no idea. I was given this drug during our induction and wasn't told any of this and thankfully didn't have any complications on it - but yes, the risks appear very significant. In fact, I was under the impression that they didn't want to administer pitocin until my cervix had dialted a certain amount. I did later get the pitocin, but wasn't aware we could have possibly gone straight to that. Thank you for publishing this information.

    Cathy said...

    Marie,
    I am so thankful you and E are healthy! When facing an induction (and something like 90% of babes will come on their own before 42 weeks) a good OB or midwife will carefully administer low doses of Pit and build up as needed. With Cytotec, once it's placed, it's placed. There's no undoing it. A Pit IV can be removed once it begins working or if there are complications.
    I needed Pit during labor (he came on his own at 42 weeks but there were unrelated issues) and I remember saying to the midwife at one point, "Don't even think about Cytotec." (She assured me she wouldn't dream of it.)
    Back when Mary was born, we didn't know any better and allowed induction at 41 weeks, but it was Pit only.
    Pit can certainly be used from the start if induction is truly needed - it will cause dilation just like Cytotec, but more safely and slowly. And more expensively.
    I highly recommend reading Dr. Wagner's book, and definitely Ina May Gaskin's Guide to Childbirth for next time. They're both not just good info, they're actually good reads. Bring a tissue for the first part of Born in the USA - I sobbed and sobbed.
    (Gaskin and Wagner are longtime dear friends, matter of fact, and often speak together about the unusually high maternal/neonate mortality rate in the United States as compared to other countries.)

    Chasing said...

    Such a great post! Thanks for the info!