Shopping Cart
Your Cart is Empty
Quantity:
Subtotal
Taxes
Shipping
Total
There was an error with PayPalClick here to try again
CelebrateThank you for your business!You should be receiving an order confirmation from Paypal shortly.Exit Shopping Cart

Sweet Pea Births

Chandler, Arizona

Sweet Pea Births

...celebrating every swee​t pea their birth

Blog

Warning Labels: Epidural Drugs

Posted on May 23, 2014 at 3:22 PM Comments comments (0)
In light of a research study published this week, we are highlighting this blog post today, originally written on May 28, 2013.

"Mainly, in all of the groups of labor pain medications and delivery method, we found that mothers who received labor pain medications were 2-3 times more likely to report [delay in the onset of lactation] DOL compared to mothers who did not use labor pain medications and delivered vaginally."

As stated below, this information is shared in the interest of true informed consent.  If a mother adds another piece to the puzzle, she may decide to choose other pain relief tools aside from pain medication, or do everything to delay pain medication as long as possible in order to give her and her baby their best opportunity to get breastfeeding off to a good start.

Bradley Method classes offered in Arizona: Chandler, Tempe, Mesa, Gilbert, Scottsdale, Ahwatukee, PaysonMay 28, 2013:
I am sharing the information below in the interest of furthering our goal that all our students have true informed consent: knowing all the benefits and risks of a drug or procedure.  It is very rare for anyone to read the drug information insert that comes in all drug packages.  To save you time and squinting, we are doing a “drug warning labels” series for the most commonly used drugs during labor and birth.  There will be two more installments in this series.  Next week we will look at the drugs used for induction, and we will conclude with drugs used for augmentation of labor.

We are passionate about helping families have their Best Possible Birth.  By that we mean the path that leads that individual family to a Healthy Mom, Healthy Baby outcome.  We want families to have a toolbox full of tips and techniques that help them manage the ebb and flow of labor.  We want them to be comfortable with the path of a normal, low-risk labor.  We want them to have true informed consent by having an open line of communication with their care providers.

Why do we spend time and energy preparing couples for natural birth, even when some of them will end up choosing an epidural, or maybe needing a cesarean for their Healthy Mom, Healthy Baby outcome?  We know that the longer drugs can be delayed or avoided completely, the less likely it is that mother and baby will be exposed to drugs that have never been proven safe for mother and baby.  As one of my favorite class handouts says, “When used wisely and at an optimal time, an epidural can give a laboring woman much needed relief and sleep.  But if you are not prepared for some of the risks, you may end up wishing you had known a little more.”  (read in more detail about epidurals HERE and HERE)

Unfortunately, some families don’t know the side effects or possible complications of the drugs that are used in childbirth today.  We assume that since they are offered, they must be safe.  After all, our care provider would not purposely put us in harm’s way, right?

Did you know that most drugs used in childbirth is used “off-label”?  There is no drug that has been proven safe for childbirth – you can’t run a control study on pregnant women by allowing some to be drug-free and then having others use the drug.  It would be highly unethical as the difference in outcomes might be devastating to the women and children involved.

In today’s post, I have pulled out five of the most common drugs used for epidural anesthesia.  I am not passing judgment on families that choose an epidural.  There are definitely times when the benefits outweigh the risks.  Each family has to make the choice that is right for them.

To be clear – we are not anti-care provider or anti-drug.  We are grateful for modern medicine that saves lives in circumstances when Mother Nature needs help.  It exists for a reason, and we are thankful for the opportunity to meet all the Healthy Moms and Healthy Babies when we hold a class reunion.

Please read and consider this information as you prepare for the birth of your baby.  I included the link to find the complete drug label on-line.  Everything underneath the drug name is in quotations because I *literally* pulled it off the label available online and onto this entry.

LIDOCAINE: Category B
“Lidocaine readily crosses the placental barrier.”

“Systemic toxicity may result in manifestations of central nervous system depression (sedation) or irritability (twitching), which may progress to frank convulsions accompanied by respiratory depression and/or arrest.” 

“The adverse experiences under Central Nervous System and Cardiovascular System are listed, in general, in a progression from mild to severe.”

“Central Nervous System: CNS reactions are excitatory and/or depressant and may be characterized by light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory reactions may be very brief or may not occur at all, in which case, the first manifestation of toxicity may be drowsiness, merging into unconsciousness and respiratory arrest.”

“Cardiovascular System: Cardiovascular reactions are usually depressant in nature and are characterized by bradycardia, hypotension and cardiovascular collapse, which may lead to cardiac arrest.”

BUPIVACAINE: Category C
“Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity.”

“Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable.”

“Epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. Epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with motor function.   The use of obstetrical anesthesia may increase the need for forceps assistance.”

“The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. This has not been reported with bupivacaine.”

CLONIDINE: Category C
“Clonidine Hydrochloride Injection (epidural clonidine) is not recommended for obstetrical, postpartum, or peri-operative pain management.  The risk of hemodynamic instability, especially hypotension and bradycardia, from epidural clonidine may be unacceptable in these patients.  However, in a rare obstetrical, post-partum or peri-operative patient, potential benefits may outweigh the possible risks.”

“Clonidine readily crosses the placenta and its concentrations are equal in maternal and umbilical cord plasma; amniotic fluid concentrations can be 4-times those found in serum.  There are no adequate and well-controlled studies in pregnant women during early gestation when organ formation takes place.  Studies using epidural clonidine during labor have demonstrated no apparent adverse effects on the infant at the time of delivery.  However, these studies did not monitor the infants for hemodynamic effects in the days following delivery.  Clonidine should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

“Labor and Delivery:  There are no adequate controlled clinical trials evaluating the safety, efficacy, and dosing of clonidine in obstetrical settings. Because maternal perfusion of the placenta is critically dependent on blood pressure, use of clonidine as an analgesic during labor and delivery is not indicated (see WARNINGS).”

“Nursing Mothers:  Concentrations of clonidine in human breast milk are approximately twice those found in maternal plasma.  Caution should be exercised when clonidine is administered to a nursing woman.  Because of the potential for severe adverse reactions in nursing infants, a decision should be made to either discontinue nursing or to discontinue clonidine.”
 
FENTANYL: Pregnancy Category C
Labor and Delivery
“Fentanyl readily passes across the placenta to the fetus; therefore, DURAGESIC® is not recommended for analgesia during labor and delivery.” 

“Serious or life-threatening hypoventilation may occur at any time during the use of DURAGESIC® especially during the initial 24-72 hours following initiation of therapy and following increases in dose.”

“Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the “sighing” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. This makes overdoses involving drugs with sedative properties and opioids especially dangerous.”

SUFENTANIL: Pregnancy Category C
“Skeletal muscle rigidity is related to the dose and speed of administration of sufentanil. This muscular rigidity may occur unless preventative measures are taken (see WARNINGS).”

“Decreased respiratory drive and increased airway resistance occur with sufentanil. The duration and degree of respiratory depression are dose related when sufentanil is used at sub-anesthetic dosages. At high doses, a pronounced decrease in pulmonary exchange and apnea may be produced.”

"There are insufficient data to critically evaluate neonatal neuromuscular and adaptive capacity following recommended doses of maternally administered epidural sufentanil with bupivacaine. However, if larger than recommended doses are used for combined local and systemic analgesia, e.g., after administration of a single dose of 50 mcg epidural sufentanil during delivery, then impaired neonatal adaption to sound and light can be detected for 1 to 4 hours and if a dose of 80 mcg is used, impaired neuromuscular coordination can be detected for more than 4 hours."

"The use of epidurally administered sufentanil in combination with bupivacaine 0.125% with or without epinephrine is indicated for labor and delivery. (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.) Sufentanil is not recommended for intravenous use or for use of larger epidural doses during labor and delivery because of potential risks to the newborn infant after delivery. In clinical trials, one case of severe fetal bradycardia associated with maternal hypotension was reported within 8 minutes of maternal administration of sufentanil 15 mcg plus bupivacaine 0.125% (10 mL total volume)."

DEMEROL: Pregnancy Category: B; D if used for prolonged periods or near term
“Lactation: excreted in breast milk”

Side effects: “Nausea, vomiting, constipation, dry mouth, flushing, sweating, lightheadedness, dizziness, drowsiness, and pain/redness at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly… Tell your doctor right away if you have any serious side effects, including: slow/irregular/fast heartbeat, mental/mood changes (e.g., confusion, hallucinations, nervousness), numbness, shakiness (tremors), trouble urinating, severe stomach/abdominal pain, change in the amount of urine.  Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizures.”

“Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea."

"This drug passes into breast milk and is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.”


This concludes the highlights I pulled out from the drug inserts.  I encourage you to click on the links and read the whole insert for yourself.  Going in with all the information may help you make the right decision for your family.  

I want to re-iterate that our perspective (Krystyna & Bruss) is that drugs are a tool, to be used wisely and at the optimal time, i.e., when the benefits outweigh the risks.  If you are going to use any of these as a tool, then educate yourselves on dosage.  You can ask questions like, "Is mom going to get the suggested dose all at once or over a time period?"  "What can we do if she needs more than the suggested dose?"  "Are there any other options?"

We have had students use an epidural as a tool after a prolonged and/or especially painful labor.  The epidural provided the rest and/or relief they needed, and some of them went on to have a quick progression to second stage and a vaginal birth.  Their births are no less "Bradley" than our mothers who had epidural-free births.  All the couples used their communication skills to make the Healthy Mom, Healthy Baby choice for their family.  

It all boils down to the same question, "Which choice is right for our family in the unique instance of our birth?"  When you choose with a Healthy Mom, Healthy Baby filter, you can help clarify which choice works for you.

Bradley Method® natural childbirth classes offered in Arizona: Chandler, Tempe, Ahwatukee, Gilbert, Mesa, Scottsdale, PaysonDisclaimer: 
The material included on this site is for informational purposes only.
It is not intended nor implied to be a substitute for professional medical advice. The reader should always consult her or his healthcare provider to determine the appropriateness of the information for their own situation.  Krystyna and Bruss Bowman and Bowman House, LLC accept no liability for the content of this site, or for the consequences of any actions taken on the basis of the information provided.  This blog contains information about our classes available in Chandler, AZ and Payson, AZ and is not the official website of The Bradley Method®. The views contained on this blog do not necessarily reflect those of The Bradley Method® or the American Academy of Husband-Coached Childbirth®.



Warning Labels: Drugs Used for Augmentation

Posted on June 21, 2013 at 11:07 AM Comments comments (0)
When looking up the drugs used that stimulate uterine contractions, Oxytocics, I also noticed that this post needs to include the drugs that are used to reverse the effect of those drugs, a group called Tocolytics.  As with the two previous posts in this series, I have listed the FDA Pregnancy category, included links to the complete drug profiles, and then pulled out the warning, adverse reaction, and contraindication sections for you to read right here and right now.

To be clear – we are not anti-care provider or anti-drug.  We are grateful for modern medicine that saves lives in circumstances when Mother Nature needs help.  It exists for a reason, and we are thankful for the opportunity to meet all the Healthy Moms and Healthy Babies when we hold a class reunion.

We are passionate about helping families have their Best Possible Birth.  By that we mean the path that leads each individual family to a Healthy Mom, Healthy Baby outcome.  We want families to have a toolbox full of tips and techniques that help them manage the ebb and flow of labor.  We want them to be comfortable with the path of a normal, low-risk labor.  We want them to have true informed consent by having an open line of communication with their care providers.

To that end, I am sharing the information below in the interest of furthering our goal that all our students have true informed consent: knowing all the benefits and risks of a drug or procedure.  It is very rare for anyone to read the drug information insert that comes in all drug packages.  To save you time and squinting, we are already researched Epidural Drugs and Induction Drugs.  To conclude the “Warning Label” Series, here are the drugs used for Augmentation and to counteract the strong contractions they have the potential to stimulate.


PITOCIN: Pregnancy Category X
http://www.drugs.com/pro/pitocin.html
Contraindications:
“Antepartum [before delivery] use of Pitocin is contraindicated in any of the following circumstances:
Where there is significant cephalopelvic disproportion;
In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery;
In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;
In fetal distress where delivery is not imminent;
Where adequate uterine activity fails to achieve satisfactory progress;
Where the uterus is already hyperactive or hypertonic;
In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord;
In patients with hypersensitivity to the drug.”

Precautions
“When properly administered, oxytocin should stimulate uterine contractions comparable to those seen in normal labor. Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. This fact must be considered by the physician in exercising his judgment regarding patient selection.”

“Except in unusual circumstances, oxytocin should not be administered in the following conditions: fetal distress, hydramnios, partial placenta previa, prematurity, borderline cephalopelvic disproportion, and any condition in which there is a predisposition for uterine rupture, such as previous major surgery on the cervix or uterus including cesarean section, overdistention of the uterus, grand multiparity, or past history of uterine sepsis or of traumatic delivery. Because of the variability of the combinations of factors which may be present in the conditions listed above, the definition of "unusual circumstances" must be left to the judgment of the physician. The decision can be made only by carefully weighing the potential benefits which oxytocin can provide in a given case against rare but definite potential for the drug to produce hypertonicity or tetanic spasm.
Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have been reported associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor.”

“Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth.
When oxytocin is used for induction or reinforcement of already existent labor, patients should be carefully selected. Pelvic adequacy must be considered and maternal and fetal conditions evaluated before use of the drug.”

Adverse Reactions
“The following adverse reactions have been reported in the mother:

  • Anaphylactic reaction
  • Premature ventricular contractions
  • Postpartum hemorrhage
  • Pelvic hematoma
  • Cardiac arrhythmia
  • Subarachnoid hemorrhage
  • Fatal afibrinogenemia
  • Hypertensive episodes
  • Nausea
  • Rupture of the uterus
  • Vomiting
  • Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction, or rupture of the uterus.”


“The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug.”

“Severe water intoxication with convulsions and coma has occurred, associated with a slow oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water intoxication has been reported.”

“The following adverse reactions have been reported in the fetus or neonate:
Due to induced uterine motility:

  •   Bradycardia
  •   Premature ventricular contractions and other arrhythmias
  •   Permanent CNS or brain damage
  •   Fetal death
  •   Neonatal seizures have been reported with the use of Pitocin.
Due to use of oxytocin in the mother:
  • Low Apgar scores at five minutes
  • Neonatal jaundice
  • Neonatal retinal hemorrhage



Related drug SYNTOCINON® - most of the information is identical
http://www.drugs.com/pro/syntocinon.html

ERGOTRATE (ERGONOVINE) – Pregnancy: Should not be administered prior to delivery or delivery of the placenta
http://www.drugs.com/mmx/ergotrate.html
Pregnancy—
“Use of ergonovine is contraindicated during pregnancy…Tetanic contractions may result in decreased uterine blood flow and fetal distress.”

Labor and delivery—
“High doses of ergonovine administered prior to delivery may cause uterine tetany and problems in the infant (hypoxia, intracranial hemorrhage) {03}. Ergonovine should not be administered prior to delivery of the placenta…Administration prior to delivery of the placenta may cause captivation of the placenta…or missed diagnosis of a second infant, due to excessive uterine contraction.”

Breast-feeding
“Problems in humans have not been documented. However, ergot alkaloids are excreted in breast milk…Although inhibition of lactation has not been reported for ergonovine, other ergot alkaloids inhibit lactation. Also, studies have shown that ergonovine interferes with the secretion of prolactin (to a lesser degree than bromocriptine) in the immediate postpartum period…This could result in delayed or diminished lactation with prolonged use.”

“Ergot alkaloids have the potential to cause chronic ergot poisoning in the infant if used in higher-than-recommended doses or if used for a longer period of time than is generally recommended.”

Pediatrics
"Elimination of ergonovine may be prolonged in newborns...Neonates inadvertently administered ergonovine in overdose amounts have developed respiratory depression, cyanosis, seizures, decreased urine output, and severe peripheral vasoconstriction."

METHERGINE: Category C
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94c9b1cf-ae12-45f3-8fcb-708a922cbc10
INDICATIONS AND USAGE
“For routine management after delivery of the placenta; postpartum atony and hemorrhage; subinvolution. Under full obstetric supervision, it may be given in the second stage of labor following delivery of the anterior shoulder.”

CONTRAINDICATIONS
"Hypertension; toxemia; pregnancy; and hypersensitivity."

TOCOLYTICS
MAGNESIUM SULFATE: Pregnancy Category A
http://www.drugs.com/pregnancy/magnesium-sulfate.html
“Studies in pregnant women have not shown evidence of fetal risk if magnesium sulfate is administered during any trimesters of pregnancy. However, because studies cannot completely rule out the possibility of harm, magnesium sulfate injection is only recommended for use during pregnancy when benefit outweighs risk.”

“Newborns may show signs of magnesium toxicity (i.e. respiratory and/or neuromuscular depression) if the mother has received intravenous magnesium sulfate prior to delivery (especially if for a period of longer than 24 hours). Equipment for assisted ventilation as well as intravenous calcium should be immediately available for the first 24 to 48 hours after delivery. One study has reported that maternal magnesium sulfate treatment is associated with reduced brain blood flow perfusion in preterm infants. However, intravenous magnesium sulfate did not lead to lower neonate Apgar scores in a study of women treated for preeclampsia even though the newborns cord level indicated hypermagnesemia.”

TERBUTALINE (BRETHINE): Pregnancy Category B
http://www.drugs.com/sfx/brethine-side-effects.html
“Terbutaline has been shown to cross the placenta, and the fetus may experience the general adverse effects reported in the mother. Pulmonary edema has been associated with the intravenous use of terbutaline in pregnant women. Myocardial necrosis in one infant was thought to be associated with terbutaline given at a rate of 0.5 mg/hr for 12 weeks by subcutaneous infusion. In one retrospective review of 8,709 patients receiving continuous low-dose subcutaneous infusion of terbutaline to arrest preterm labor, only 47 (0.54%) had one or more cardiopulmonary problems. Pulmonary edema was reported in 28 patients (0.32%), 17 of whom had been treated concurrently with large amounts of IV fluids or one to three tocolytic agents and four of whom had been diagnosed with pregnancy-induced hypertension and/or multiple gestation. Other cardiovascular effects occurred in 19 patients (0.22%), including electrocardiogram changes, irregular heart rate, chest pain, or shortness of breath. However, 7 of these patients had a history of cardiac problems. Use of terbutaline in pregnant women for the relief of bronchospasm may interfere with uterine contractility. For the treatment of asthma, administration by metered dose inhaler results in lower plasma concentrations and consequently fewer adverse effects for the mother and fetus. Hepatitis has been reported in at least two patients receiving terbutaline to control premature labor.”

“Terbutaline has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity. Terbutaline is only recommended for use during pregnancy when benefit outweighs risk.”

INDOMETHACIN (NSAID): Pregnancy Category C
http://www.drugs.com/pregnancy/indomethacin.html
“Animal studies have failed to reveal evidence of teratogenicity or fetal harm except at doses which result in significant maternal toxicity. There are no controlled data in early human pregnancy. Indomethacin has been used in the management of premature labor. However, fetal hemodynamic changes, premature closure of the ductus arteriosus resulting in neonatal primary pulmonary hypertension, and neonatal oliguric renal failure, oligohydramnios, hemorrhage, and intestinal perforation have been reported as a result of this tocolytic therapy. Indomethacin is only recommended for use during pregnancy when benefit outweighs risk.”

“Indomethacin crosses the placenta. In one study, 26 pregnant patients were administered indomethacin 50 mg orally one time approximately six hours prior to scheduled cordocentesis, at a gestational age of 23.6 to 36.6 weeks. At the time of the procedure, maternal serum indomethacin concentrations ranged from 42 to 690 ng/mL (mean 218 ng/mL) while fetal concentrations ranged from 87 to 496 ng/mL (mean 219 ng/mL). The mean maternal to fetal serum concentration ratio was 0.97. There was no correlation between gestational age and maternal/fetal ratio. Amniotic fluid concentrations averaged 21 ng/mL. Indomethacin has been used successfully in the treatment of premature labor as well as polyhydramnios. In several studies, indomethacin was as effective and better tolerated than beta-agonists for premature labor. However, while earlier reports and studies suggested indomethacin was safe for the fetus or neonate, especially when use was confined to pregnancies of 34 weeks gestation or less, more recent data suggest a substantial increase in the risk of serious fetal or neonatal side effects. Eronen (1993) studied the effects of indomethacin or nylidrin on the fetal and neonatal ductus arteriosus and tricuspid valve function. A total of 84 pregnancies (94 fetuses) with premature labor between 22.9 and 34.0 weeks gestation were evaluated. Ductal constriction occurred in 46/49 (86%) of fetuses (gestational age 24.0 to 34.0 weeks) treated with indomethacin. The gestational age of the fetuses without ductal constriction ranged from 24.3 to 28.6 weeks. Eleven fetuses with ductal constriction also had tricuspid regurgitation. Data from this study suggest increasing reactivity of the ductus with increasing gestational age; although, ductal constriction occurred in one fetus at 22.9 weeks gestation. In addition to hemodynamic changes, other serious sequelae of maternal indomethacin use have been documented. One study compared 57 infants delivered at or before 30 weeks gestation whose mothers received indomethacin for the treatment of premature labor with 57 infants whose mothers had not received indomethacin. The total dose of indomethacin ranged from 50 to 6000 mg (median 425 mg) and the duration of therapy ranged from 1 to 79 days (median 3 days). Necrotizing enterocolitis occurred in 29% of infants exposed to indomethacin compared with an 8% incidence in the control group (p=0.005). Intracranial hemorrhage occurred in 28% of infants in the indomethacin group compared with only 9% in the control group (p=0.02). Maternal use of indomethacin has resulted in reduced fetal urine output and subsequent oligohydramnios, neonatal renal failure, fetal pleural effusion, and ileal perforation. In addition, at least two cases of neonatal lower limb ischemia have been reported following prolonged intrauterine exposure to indomethacin. Fetal echocardiograms after 24 hours of maternal indomethacin therapy and then weekly, thereafter, if long-term therapy is necessary, have been recommended. In addition, assessment of amniotic fluid volume is also recommended.”

RITODRINE (YUPOTAR): Pregnancy Category B
http://www.drugs.com/pregnancy/ritodrine.html
“There are no controlled data in human pregnancy. Neonatal hypoglycemia, tachycardia, and ileus have been reported. Rarely, ketoacidosis resulting in fetal death has been reported. Ritodrine is only recommended for use during pregnancy when benefit outweighs risk.”

Disclaimer: 
The material included on this site is for informational purposes only.
It is not intended nor implied to be a substitute for professional medical advice. The reader should always consult her or his healthcare provider to determine the appropriateness of the information for their own situation.  Krystyna and Bruss Bowman and Bowman House, LLC accept no liability for the content of this site, or for the consequences of any actions taken on the basis of the information provided.  This blog contains information about our classes available in Chandler, AZ and Payson, AZ and is not the official website of The Bradley Method®. The views contained on this blog do not necessarily reflect those of The Bradley Method® or the American Academy of Husband-Coached Childbirth®.
Bradley Method® natural childbirth classes offered in Arizona: Chandler, Tempe, Ahwatukee, Gilbert, Mesa, Scottsdale, Payson

Warning Labels: Induction Drugs

Posted on June 7, 2013 at 4:20 PM Comments comments (0)
This is the second post in the series that looks at the small print on the drug information sheet for consumers.  In our first post, we looked at the details of drugs used in epidurals.  Here is the fine print for the drugs used by hospital practitioners to induce labor.  This may be offered for a variety of reasons.  

Whenever a drug or procedure is offered, we encourage our students to look at the benefits and the risks.  There are circumstances where the benefits clearly outweigh the risks.  It is up to each family to individually decide what works best for them and their baby.  In the spirit of informed consent, here is the fine print and FDA Pregnancy Category for Cervadil (Brand Name for a form of Dinoprostone), Dinoprostone, Cytotec (Misoprostol) and Pitocin.


To be clear – we are not anti-care provider or anti-drug.  We are grateful for modern medicine that saves lives in circumstances when Mother Nature needs help.  It exists for a reason, and we are thankful for the opportunity to meet all the Healthy Moms and Healthy Babies when we hold a class reunion.

Please read and consider this information as you prepare for the birth of your baby.  I included the link to find the complete drug label on-line.  As with last week, everything is in direct quotes because the information is pulled from the drug information made available by the Federal Drug Administration (USA).

CERVADIL: Pregnancy Category C
http://www.drugs.com/pro/cervidil.html
Cervidil is contraindicated in:
"- Patients with known hypersensitivity to prostaglandins.
- Patients in whom there is clinical suspicion or definite evidence of fetal distress where delivery is not imminent.
- Patients with unexplained vaginal bleeding during this pregnancy.
- Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion.
- Patients in whom oxytocic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery (see PRECAUTIONS and ADVERSE REACTIONS).
- Patients already receiving intravenous oxytocic drugs.
- Multipara with 6 or more previous term pregnancies."

"Warnings
Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of postpartum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction (See ADVERSE REACTIONS, Post-marketing surveillance). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum period.
The Clinician should be alert that use of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism)."

"Precautions
General: Since prostaglandins potentiate the effect of oxytocin, Cervidil must be removed before oxytocin administration is initiated and the patient's uterine activity carefully monitored for uterine hyperstimulation. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Cervidil should also be removed prior to amniotomy.
Cervidil is contraindicated when prolonged contraction of the uterus may be detrimental to fetal safety and uterine integrity. Therefore, Cervidil should not be administered to patients with a history of previous cesarean section or uterine surgery given the potential risk for uterine rupture and associated obstetrical complications, including the need for hysterectomy and the occurrence of fetal or neonatal death.

2. Drug Interactions: Cervidil may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert. No other drug interactions have been identified."

"Post-marketing surveillance:
Immune System Disorders: Hypersensitivity
Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See WarningsSection)
Reproductive system: Reports of uterine rupture have been reported in association with use of Cervidil some required a hysterectomy and some resulted in subsequent fetal or neonatal death.
Vascular Disorders: Hypotension
Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism"
"Contraindications:
Hypersensitivity to dinoprostone, prostaglandins, or any components of the product; patients in whom oxytocic drugs are contraindicated or when prolonged contractions of uterus are considered inappropriate; ruptured membranes; placenta previa; unexplained vaginal bleeding during current pregnancy; when vaginal delivery is not indicated; acute pelvic inflammatory disease; active cardiac, pulmonary, renal, or hepatic disease (suppository only)."

"General advice:
Carefully examine vagina to determine degree of effacement and appropriate length of endocervical catheter to be used for application of gel (10 mm if 50% effaced, 20 mm if no effacement).
Patient should be in dorsal position for administration and remain supine for 15 to 30 min after administration of cervical gel.
Following administration of vaginal suppository, the patient should remain in the supine position for 10 min.
Following administration of the vaginal insert, the patient should remain in a recumbent position for 2 h.
Inserts do not require warming prior to administration.
Suppositories and gel must be brought to room temperature. Do not use external sources of heat (eg, hot water bath, microwave oven) to decrease warming time.
Wait at least 6 to 12 h after administration of gel before using IV oxytocin; a dosing interval of at least 30 min is recommended after removal of insert.
Do not use dinoprostone vaginal suppository for extemporaneous preparation of any other dosage forms or for cervical ripening or other indications in the patient with term pregnancy."

"May augment effect of other oxytocic agents; avoid concomitant use. For the sequential use of oxytocin following dinoprostone cervical gel administration, a dosing interval of 6 to 12 h is recommended. A dosing interval of at least 30 min is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert."

"Pregnancy Category C. Contraindicated if fetus in utero has reached viability stage except when cervical ripening is indicated."

"Lactation: Undetermined."

"Special Risk Patients
Use with caution in patients with asthma, glaucoma, or raised IOP, hypotension or hypertension, CV or renal or hepatic impairment, anemia, jaundice, diabetes, epilepsy, compromised uterus, infected endocervical lesions, acute vaginitis, in patients with cases of non-vertex or non-singleton presentation, and in patients with a history of previous uterine hypertony.
-Anaphylactoid syndrome of pregnancy Intracervical placement of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue, and rarely leads to development of anaphylactoid syndrome of pregnancy (amniotic fluid embolism).
- Incomplete pregnancy termination If dinoprostone pregnancy termination is incomplete, take other measures to ensure complete abortion.
- Postpartum disseminated intravascular coagulation An increased risk has been described in patients whose labor was induced by physiologic means. Women who are 30 y and older, those with complications during pregnancy, and those with gestational age more than 40 wk are at risk.
- Pyrexia Transient pyrexia (temperature elevations in excess of 2°F), possibly due to the dinoprostone effect on hypothalamic regulation, was observed in 50% of patients receiving suppositories at the recommended dosage. Temperature returned to normal on discontinuation of therapy.
- Ruptured membranes Exercise caution when administering dinoprostone cervical gel or vaginal insert to patients with ruptured membranes.
- Uterine hyperstimulation Placement of dinoprostone cervical gel into the extra-amniotic space has been associated with uterine hyperstimulation. When using the vaginal insert, if uterine hyperstimulation is encountered or if labor starts, the vaginal insert should be removed."

CYTOTEC/MISOPROSTOL: Pregnancy Category X
http://www.drugs.com/search.php?searchterm=Cytotec
"Generic Name: misoprostol (MYE-soe-PROST-ol) Brand Name: Cytotec Do not take Cytotec to reduce the risk of stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs) if you are pregnant. Cytotec may cause abortion, premature birth, or birth defects if taken during pregnancy. Life-threatening..."
(My note: yes - this is just how it appears - with the ellipsis there)

"Misoprostol has been assigned to pregnancy category X by the FDA. Animal studies have failed to reveal evidence of fetotoxicity and teratogenicity. In studies of women undergoing elective first trimester abortion, the administration of misoprostol 400 mcg for two doses caused increased uterine contractions and bleeding in 41% of cases, and partial or complete expulsion of uterine contents in 11% of cases." 

"Breastfeeding Warnings
Misoprostol is rapidly metabolized in the mother to misoprostol acid which is biologically active and is excreted in human breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol. The manufacturer recommends that caution should be exercised when misoprostol is administered to a nursing woman."
"What should I discuss with my healthcare provider before receiving Pitocin (oxytocin)?
You should not receive this medication if you have ever had an allergic reaction to oxytocin."

"To make sure oxytocin is safe for you, tell your doctor if you have:
genital herpes;
diabetes;

    • high blood pressure;
    • a heart rhythm disorder;
    • a history of cervical cancer;
    • a history of severe infection in your uterus;
    • a history of difficult labor because you have a small pelvis;
    • if you have ever had surgery on your cervix or uterus (including a prior C-section);
    • if your pregnancy is less than 37 weeks; or
    • if you have had 5 or more pregnancies.’’

"Tell your caregivers at once if you have a serious side effect such as:
fast, slow, or uneven heart rate;
excessive bleeding long after childbirth;
headache, confusion, slurred speech, hallucinations, severe vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, seizure (convulsions), fainting, shallow breathing or breathing that stops; or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure)."

"Less serious side effects may include:


    • nausea, vomiting;
    • runny nose, sinus pain or irritation;
    • memory problems; or
    • more intense or more frequent contractions (this is an expected effect of oxytocin)."

"For Health Professionals
Hepatic side effects have included neonatal jaundice."
Read more at HERE 

"Genitourinary
Genitourinary side effects have included pelvic hematoma. Excessive doses have produced pelvic fracture, uterine hypertonicity, spasm, tetanic contraction and rupture."

"Hematologic
Hematologic side effects have included postpartum hemorrhage and fatal afibrinogenemia."
Read more HERE 

"General side effects have include low Apgar scores at 5 minutes. Fetal death has been reported."
Read more HERE 


As you can see from the insert information and the pregnancy categories assigned by the FDA, these are not inherently safe just because they are commonly used.  Any parent who is being asked to use these should do so after careful consideration of the risks and the benefits.  You can use this series of questions to help you determine if the benefits outweigh the risks:
  • Is Mom okay?
  • Is Baby okay?
  • What are the benefits of using this drug?
  • What are the risks of using this drug? (You have the right to read the drug insert for yourself in the care facility)
  • What else is going to happen if we say yes? (Additional procedures, time in bed, time being monitored, position for mom, etc.)
  • What are the expected results?  What if we don’t see them? 
  • What are the alternatives if we choose not to do this?
  • What does our intuition tell us?
  • What happens if we choose to do nothing?

Any advice to offer about being induced?
Please leave us a comment - it will be moderated and posted.  *I think* that the amount of traffic you so generously generate has led to a lot of spam posting.  In an effort to keep the spam to a minimum, I am taking the time to moderate comments now.

Bradley Method® natural childbirth classes offered in Arizona: Chandler, Tempe, Ahwatukee, Gilbert, Mesa, Scottsdale, Payson
Disclaimer:  
The material included on this site is for informational purposes only.
It is not intended nor implied to be a substitute for professional medical advice. The reader should always consult her or his healthcare provider to determine the appropriateness of the information for their own situation.  Krystyna and Bruss Bowman and Bowman House, LLC accept no liability for the content of this site, or for the consequences of any actions taken on the basis of the information provided.  This blog contains information about our classes available in Chandler, AZ and Payson, AZ and is not the official website of The Bradley Method®. The views contained on this blog do not necessarily reflect those of The Bradley Method® or the American Academy of Husband-Coached Childbirth®.