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.

Bupivacaine

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.

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.

Butorphanol

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.

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.

Clonidine Hydrochloride

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

Limited human data

Dinoprostone

The manufacturer warns "Prostin E2 vaginal suppository should not be used for cervical ripening."

Vomiting and/or nausea.

Diarrhea

Fever

Headache

Chills

Backache

Uterine rupture

Maternal and fetal death

Cardiac arrhythmia

Vaginal pain

Chest pain

Hearing impairment

Etc

Fentanyl

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.

Potency approximately 81 times that of morphine

Causes loss of fetal heart rate variability.

Neonatal respiratory depression may occur.

Hydromorphone

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.

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.

Meperidine or Pethidine

Note: It is the most common drug used in labor.

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.

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.

Misoprostol

Water is a wonderful way to relax during labor

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.

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.

Morphine

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.

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.

Nubaine

This means that there have been no adequate - and well controlled - studies done on pregnant women. Studies on animals in reproduction do not indicate risk to the baby. It crosses the placenta.

The placental transfer of nubain from mom to baby is high, rapid, and variable, with a maternal to fetal ratio ranging from 1:0.37 to 1:6.

No adequate data in first trimester exist.

Fetal and neonatal adverse events have included reports of fetal bradycardia, respiratory depression at birth, apnea, cyanosis, and hypotonia. Some of these events have been life-threatening.

The FDA advises that Nubain be used during labor and delivery only if clearly indicated and the potential benefit outweighs the risk to the infant. Newborns exposed to maternal Nubain should be monitored for respiratory depression, apnea, bradycardia, and arrhythmias.

The FDA also states that there are serious risks for serious fetal and neonatal adverse events when Nubain is used during labor and delivery.

Nubain may also cause a decreased memory of your birthing experience. This is something that most women regret afterward.

Prochlorperazine

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.

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.

Propofol

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.

Limited human data.

If used in labor or cesarean section may cause neonatal hypotonia - poor muscle tone, and low Apgar score.

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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