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Sunday
May302010

« Pitocin not approved by the FDA for elective (or non-medical inductions). »

PITOCIN (oxytocin) Mnfr: MONARCH PHARMACEUTICALS, INC

PITOCIN has been approved by the FDA for the medical induction and stimulation of labor. Pitocin has not approved for the elective induction or stimulation of labor.

Source: FDA APPROVED OBSTETRICS DRUGS: THEIR EFFECTS ON MOTHER AND BABY

Which means, that the common use of Pitocin in hospitals for inducing a mother post dates (without medical reason) is highly dangerous. The risks are too high for a non-medical induction. The use pitocin in labour to 'speed things up' is not FDA approved. You can refuse pitocin augmentation unless medical indicated that there is a reason other than someones bed space and watch ticking. 

"Oxytocin crosses the placenta and enters the blood and brain of the fetus within seconds or minutes. There appears to be a correlation between fetal exposure to oxytocin and autism in the exposed offspring."

The manufacturer of oxytocin warns the provider in the package insert:

"Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, fetal deaths and permanent CNS or brain damage of the infant due to various causes have been reported to be associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor."

Because oxytocin is used so commonly to stimulate labor we note here that, in addition to the more benign effects of uterine stimulants, such as nausea and vomiting, the manufacturer of Pitocin (oxytocin) points out in its package insert that oxytocin can cause: 

(a) maternal hypertensive episodes (abnormally high blood pressure)

(b) subarachnoid hemorrhage (bleeding in area surrounding spinal cord) 

(c) anaphylactic reaction (exaggerated allergic reaction)

(d) postpartum hemorrhage (uterine hemorrhage following birth)

(e) cardiac arrhythmias (non-normal heart rate)

(f) fatal afibrinogenemia (loss of blood clotting fibrin)

(g) premature ventricular contraction(non-normal heart function)

(h) pelvic hematoma (blood clot in the pelvic region)

(i) uterine hypertonicity (excessive uterine muscle tone)

(j) uterine spasm (violent, distorted contraction of the uterus)

(k) tetanic contractions (spasmodic uterine contractions)

(l) uterine rupture

(m) increased blood loss

(n) convulsions (violent, involuntary muscle contraction(s).

(o) coma (unconsciousness that cannot be aroused)

(p) fatal oxytocin-induced water intoxication (undue retention of water marked by vomiting, depression of temperature convulsions, and coma and may end in death.

Fetal and Newborn Effects

The following adverse effects of maternally administered oxytocin have been reported in the fetus or infant:

(a) bradycardia (slow fetal heart rate)

(b) premature ventricular contractions and other arrhythmias (non-normal heart function)

(c) low 5 minute Apgar scores (non-physiologic neurologic evaluation)

(d) neonatal jaundice (excess bilirubin in the blood of the neonate.

(e) neonatal retinal hemorrhage (hemorrhage within the innermost covering of the eyeball)

(f) permanent central nervous system or brain damage

(g) fetal death

"Uterine stimulants which foreshorten the oxygen-replenishing intervals between contractions, by making the contractions too long, too strong, or too close together, increase the likelihood that fetal brain cells will die.

The situation is analogous to holding an infant under the surface of the water, allowing the infant to come to the surface to gasp for air, but not to breathe. All of these effects increase the possibility of neurologic insult to the fetus. No one really knows how often these adverse effects occur, because there is no law or regulation in any country which requires the doctor to report an adverse drug reaction to the FDA.

These findings underscore the importance of the midwife managing the woman's labor in a way that will avoid the need for Pitocin and the pain relieving drugs that are often administered to help the woman cope with the contractions intensified by Pitocin.

DELAYED LONG TERM EFFECTS: There have been no adequate and well-controlled studies to determine the delayed, long-term effects of Pitocin on pregnant women, or on the neurologic, as well as general, development of children exposed to Pitocin in utero or during lactation."

Here is manufacturers insert including warnings and uses of Pitocin.

Were you aware that the drug so commonly used on pregnant women without medical indication is not FDA approved? I didn't. Were you aware of all the risks involved in this drug, that is used so often?  

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Reader Comments (9)

This makes me so sick to my stomach. And people argue that homebirth isn't safe. Please.
June 1, 2010 | Unregistered CommenterSara E. Cotner
Wow this is just wonderful. Ugh. I followed the typical hospital birth bath with my first...strapped down to monitors, no progress (duh, I couldn't MOVE!) Then the epidural, then the pitocin, then her heartrate dropped. Thank God I avoided the c-section.

Second birth was a minimal intervention hospital birth, still FULL of unneccesary interventions though (antibiotics, IV, monitoring, VEs etc etc)

NO MORE!
June 9, 2010 | Unregistered CommenterMaria
Wow. Powerful information. Do you have a link to the studies referenced?
June 10, 2010 | Unregistered CommenterAmanda Spakowski
@Amanda

The link to the FDA page is above under 'Source' or here...http://www.aimsusa.org/obstetricdrugs.htm

And the manufacturers insert is here...http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf

Thanks
Awesome post! I would love to share this info with my clients. So many blindly go along with whatever their OB tells them (we have no Midwives in this area...YET). I saw a quote once that said "Pitocin is the most ABUSED drug in the world"...or something like that. We need to fight for our moms and babies who really don't know the danger their so called "care providers" can put them in. Thanks again for a wonderful post!
June 14, 2010 | Unregistered CommenterBrandi
The opinions you provid are of grat help, I like your blog, thank you.
June 20, 2010 | Unregistered Commentercreative recreation
Thank you!

This gets me thinking, though - For moms who "must" have an induction (for whatever reason, which may not actually be "medical") but want to avoid pitocin for the reasons listed, here, I wonder what the next best option is....? AROM? Cervadil? Foley bulb?

Thoughts?
July 5, 2011 | Unregistered CommenterEmily
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I love this information. I have been kind of battling with our doctor about not inducing as our due date was on July 26 and she wants to induce today Aug. 01. I have asked her on what information she is basing the induction and it is on post due date alone. We have not had an ultrasound to check the amniotic fluid levels as well as the condition of the placenta. Fetal movement is still very normal, with kick counts as well as the same active times our baby has had for several months now. We will try to hold out, but now our doctor is telling us the latest date she feels comfortable with is Wed Aug 3. This is our first pregnancy as well so 10 days past due is very normal. Anyway nice blog and great consolidation of information.
August 1, 2011 | Unregistered CommenterBen

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