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Are There Safe Drugs During Pregnancy and Labor?
Are there any safe drugs during pregnancy and labor?
Yes this question does need to be asked.
Like the rest of the population, you would like to think that indeed drugs used in pregnancy and
labor are safe. After all, we are told they are safe. Aren't they all FDA approved?
Yes indeed they are.
Note: When we say drugs we mean mostly pharmaceutical
drugs and this does include over the counter medications as well.
However the facts about drugs in pregnancy, labor and breastfeeding are quite different.
Safe drugs during pregnancy is a truly fallacy - a myth. Granted some are safer than others and we recognize that some are necessary
AND lifesaving. However all pharmaceutical drugs - and that includes over the counter medications - to be labeled as a drug
by the FDA must first
meet two criteria. They must:
Kill
Be toxic
This is what the FDA drug approval process is all about. How quickly does it kill - LD-50 - and how toxic is the drug. The LD-50 - or
lethal dose 50% - is the very first step in the drug approval process.
Any drug MUST be able to kill half the lab animals it is tested on - and eventually - all of them. From this test, the dosage that
can be "safely" used on you will be determined.
So are there any safe drugs in pregnancy?
If a drug cannot meet this first step..it is then
labeled a natural remedy!
Here are some more facts about drugs: The other two steps of the FDA approval process involve drug interaction and labeling the drug for ONE
specific ailment. After approval, the use
of a drug for something other than the one ailment it was approved for is called "off-label" use. Off-label use means that you have
now become a guinea pig
and the drugs are used on "hear-say" rather than approval.
In the United States, the "off-label" use of drugs is over 90%!
Pregnancy drugs are used for anything from nausea to labor induction. The most well known
for labor induction or augmentation is Pitocin which
in this case is
an "off-label use of this dangerous drug. But let's not forget another labor inducing
drug: Cytotec.
Pregnancy drugs are also use for pain
relief in labor to treating after birth pains.
All of them are as we have said before FDA approved drugs.
However, the fact remains that NO drugs during pregnancy have ever been approved by the FDA for the safety of your
unborn baby...only the unpregnant mother. It is actually illegal - for obvious reasons - to test medications on pregnant mothers.
This means that the "safety" and the dosage of a drug are based solely on you - the mother - and not your baby.
Here are more facts about drugs which are used in pregnancy and birth. Remember the "off-label" use we mentioned earlier?
Well, did you know that most - if not all - of the pregnancy drugs currently used are used "off label?"
What does this mean for you and your baby?
It means that pharmaceutical drugs were approved for something other than for child birth, pregnancy or lactation.
As a matter of fact, No, we repeat, there are no pregnancy drugs approved for:
Pregnancy
Labor
So we ask you...are there any safe drugs in pregnancy and labor?
Here is another fact: the dosage for any medication is based on the mother's weight and size...remember that your unborn baby is but a fraction
or your height and weight and drugs do cross the placental barrier.
Note that the following is by no means a complete list of all pharmaceutical drugs used during pregnancy and in childbirth.
Research shows that labor drugs do affect
your baby...sometimes long term.
Safe Drugs During Pregnancy and Labor?
Bupivacaine
Trade name: Marcaine, Marcaine Spinal, Sensorcaine, Sensorcaine Forte, Sensorcaine-MPF, Sensorcaine-MPF Spinal, Marcain, Marcain Heavy
FDA approved use: Local pain relief
Off-label use: Labor medication used for pain relief and in lactating women
Pregnancy category: C
C - Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and
well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
Crosses the placenta
Animal studies revealed that the use of this pregnancy drug increased incidence of
fetal death and skeletal abnormalities when used in high doses.
Bupivacaine has caused several deaths when the epidural anesthetic has been administered intravenously accidentally.
In a study Dr. Rosenblatt said that after delivery, babies who had been exposed to this drug were more likely to be cyanotic - blue - and to be
unresponsive to their surroundings.
Visual skills and alertness decreased significantly with increases in the cord-blood concentration. This was true on
the first day of life and through the next six weeks.
The baby's motor organization, physiological responses in response to stress were
also affected.
The effects were still seen at six weeks post-partum and this was deemed to be long term.
Breastfeeding: Passes through breast-milk
Top of page
Butorphanol
Trade name: Stadol
FDA approved use: Pain relief specifically migraines
Off-label use: One of the pregnancy drugs used as a labor medication and in lactating women
Pregnancy category: C/D
C - Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and
well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
D - There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience
or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
Use of the drug during labor may cause an abnormal fetal heart pattern without fetal hypoxia - asphyxia - or neonatal adverse effects.
Prolonged use of the drug may cause neonatal withdrawal symptoms.
40 times more potent than Demerol.
Affects the fetal brain and nervous system.
Respiratory distress.
Psychotic effects.
Etc.
Breastfeeding: Passes through breast-milk
Top of page
Clonidine Hydrochloride
Trade name: Catapres
FDA approved use: Hypertension
Off-label use: One of the pregnancy drugs use for pain relief in lactating women
Pregnancy category: C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and
well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Documented risks:
Limited human data
Breastfeeding: Passes through breast-milk, unknown long-term effects.
Top of page
Dinoprostone
Trade name: Prostin E, Cervidil, Prepidil
FDA approved use: Abortion
Off-label use: Labor induction, pregnancy, lactation
Pregnancy category: Not rated
Documented risks:
Vomiting and/or nausea.
Diarrhea
Fever
Chills
Uterine rupture
Maternal and fetal death
Cardiac arrhythmia
Etc
Breastfeeding: No data
Top of page
Fentanyl
Used in epidurals
Trade name: Actiq
FDA approved use: Narcotic, pain relief.
Off-label use: One of the pregnancy drugs used as labor medication during labor and in lactating women
Pregnancy category: C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled
studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
Potency approximately 81 times that of morphine
Causes loss of fetal heart rate variability.
Neonatal respiratory depression may occur.
Breastfeeding: Passes through breast-milk.
Top of page
Hydromorphone
Trade name: PMS-Hydromorphone
Other names: Dilaudid, Dilaudid-5, Dilaudid-HP, Hydrostat IR, PMS-Hydromorphone Syrup
FDA approved use: Narcotic, pain relief, opiate.
Off-label use: One of the pregnancy drugs used for pain relief during labor and in lactating women.
Pregnancy category: C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies
in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
It has the ability to cross the blood-brain barrier and therefore it has a more rapid and complete central nervous system penetration.
It is somewhat faster-acting and about eight times stronger than morphine and about three times stronger than heroin on
a milligram basis.
Limited human data, but no association with congenital defects reported.
Maternal prolonged use may cause neonatal withdrawal.
If used in labor may cause neonatal respiratory depression.
Breastfeeding: Unknown excretion into human breast milk.
Top of page
Meperidine or Pethidine
Note: It is the most common drug used in labor.
Trade name: Demerol
FDA approved use: Narcotic for pain relief.
Off-label use: One of the pregnancy drugs used for pain relief during labor and in lactating women.
Pregnancy category: C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled
studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
Crosses the placenta. Because baby's liver is immature, it takes a lot longer to eliminate the drug from its system.
Causes neonatal respiratory depression. If the baby's breathing is depressed at birth, one must give Naxolone at birth.
Naxolone is a drug used to counter the effects of overdose.
Because of slow elimination the baby may have impaired behavioral response and EEG changes may persist for several days.
Breastmilk: Passes through breast-milk, which means baby gets a second dose if breastfed at birth.
Top of page
Misoprostol
 | Water is a wonderful way
to relax during labor |
|---|
Trade name: Cytotec
FDA approved use: prevention of gastric ulcers
Off-label use: labor induction
Pregnancy Category: X
Positive evidence of human fetal risk exists.
Studies in animals and/or humans have demonstrated fetal abnormalities.
Fetal risk involved in use of drug, clearly
outweighs potential benefit.
Contraindicated in women who are or may become pregnant. Do not use.
Documented risks:
It is teratogenic - cancer causing - in the baby. It produces limb, digital, skull defects, cleft lip and palate, etc.
Fetal death and severe fetal brain damage.
Uterine rupture
Maternal death
Uterine hyperstimulation
Fluid embolism
Retained placenta
Hysterectomy
Etc.
Breastfeeding: Passes through breast-milk
Top of page
Morphine
FDA approved use: Narcotic for severe pain relief
Off-label use: One of the pregnancy drugs used as labor medication and in the lactating woman
Pregnancy category: C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled
studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
Crosses human placenta rapidly
No adequate data in first trimester exposure but reported association with inguinal hernia after anytime use during pregnancy.
Chronic maternal use of the drug causes neonatal withdrawal and respiratory depression.
Breastfeeding: Passes through breast-milk
Top of page
Prochlorperazine
Trade name: Compazine
Other names: Buccastem, Compazine Spansule, Nu-Prochlor, PMS Prochlorperazine, Stemetil, Stemetil Liquid
FDA approved use: Nausea and vomiting, vertigo, tranquilizer
Off-label use: Pregnancy, labor and breastfeeding, nausea, morning sickness
Pregnancy category: C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies
in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
In animal it causes cleft palate, anencephaly, behavioral changes, decrease in postnatal weight and increased fetal mortality.
Crosses human placenta.
Isolated reports of congenital anomalies in infants exposed in utero to the drug such as cleft palate, heart defects, skeletal defects.
Breastfeeding: Unknown excretion into milk, may cause sedation in nursing infants
Top of page
Propofol
Trade name: Diprivan 1
Other names: Diprivan 1%
FDA approved use: Hypnotic for I.V. induction and maintenance of anesthesia
It has been banned by the FDA for
use in C-sections
Off-label use: Pregnancy, labor and breastfeeding
Pregnancy category: C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled
studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Documented risks:
Limited human data.
If used in labor or cesarean section may cause neonatal hypotonia - poor muscle tone, and low Apgar score.
Breastfeeding: Excreted into milk, no data available about safety
Top of page
So now we ask what do you think about "safe drugs during pregnancy and labor?"
Granted - as we have said previously - they are times when the benefits of using medication far outweigh the risks of not using them. There
are
indeed many times when pharmaceutical drugs are life saving, and in those cases they should be used.
There are other times when natural options are available - especially
for common pregnancy ailments.
Childbirth may be another time when you should avoid using pharmaceutical drugs for obvious reasons.
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