Unsafe Medications in Pregnancy, Labor, Delivery and Lactation

What Your Doctor Doesn't Tell You CAN Hurt You

The use of medications in pregnancy that are not designed nor approved for pregnancy, labor and lactation is called "off-label" use.  The chances are quite high that your doctor is guilty of using or prescribing at least one of these drugs to his patients.  It even could have been you.

 In some instances, the manufacturers and FDA have even provide detailed warnings prohibiting the use of such drugs in pregnancy, labor and lactation, all of which are still being ignored by physicians on a daily basis.

Below is a minimal listing of off-label use of medications in pregnancy, labor, delivery and lactation.  These are NOT FDA-approved and pose serious risks to mothers and their children:

Cytotec/Misoprostol
Approved Use:  Prevention of stomach ulcers
Unapproved Use:  Abortion, pregnancy, labor, delivery and lactation
Common Off-Label Use: Labor induction, abortion, cervical ripening agent, postpartum bleeding
Specific Warnings:  "Cytotec is not approved for the induction of labor and delivery or abortion.  Cytotec is a synthetic analog of prostaglandin E1, and as such can induce or augment uterine contractions.  Cytotec has been used outside of its (FDA) approved indication, as a cervical ripening agent for the induction of labor or abortion, in spite of specific contraindications to its use during pregnancy." Both the FDA and its manufacturer issued statements in 2000 that it is not to be used for induction of labor, delivery, or abortion.  Drug has a picture of a pregnant woman with a line through it as a universal symbol to avoid while pregnant.
Documented Risks: Uterine rupture, maternal death, fetal death, uterine hyperstimulation, uterine perforation, amniotic fluid embolism, vaginal hemorrhage, retained placenta, fetal bradycardia, hysterectomy
Source: Physician's Desk Reference page 2991


Prostin E/Dinoprostone
Approved Use: Abortion
Unapproved Use: Pregnancy, labor delivery or lactation
Common Off-Label Use: Cervical ripening for artificial labor induction
Specific Warnings: "Prostin e2 vaginal suppository should not be used for cervical ripening." "Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosage. Dinoprostone should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities."
Documented Risks: Vomiting, diarrhea, nausea, fever, headache, chills or shivering, backache, joint inflammation or pain, flushing or hot flashes, dizziness, anthelia, vaginal pain, chest pain, dyspnea, endometritisis, syncope or fainting, vaginitis or vulvitis, weakness, muscle cramp or pain, tightness in chest, nocturnal leg cramps, uterine rupture, breast tenderness, blurred vision, coughing, rash, myalgia, stiff neck, dehydration, tremor, pain, wheezing, cardiac arrhythmia, skin discoloration, vaginismus, and tension.
Source: Physician's Desk Reference page 2638



Stadol/Butorphanol Tartrate
Approved Use: Narcotic pain relief
Unapproved Use: Pregnancy, labor, delivery and lactation
Common Off-Label Use: Labor and delivery pain relief
Specific Warnings:  "40 times more potent than Demerol: 2mg Stadol = 10mg Morphine; crosses placenta in minutes and enters all fetal organs, including the brain and central nervous system; perform Neurobehavioral testing on all infants exposed to the drug during delivery."
Documented Risks:  Respiratory distress, cardiovascular dysfunction, psychotic effects, motor impairments, bladder impairments, lung dysfunction
Source: Physician's Desk Reference page 2991



Catapres/Clonidine HCL
Approved Use: Hypertension
Unapproved Use: Pregnancy, labor, delivery or lactation
Common Off-Label Use: Labor and delivery anesthesia
Specific Warnings: "No adequate, well-controlled studies have been conducted in pregnant women.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."
Source: Physician's Desk Reference page 968



Morphine
Approved Use: Narcotic for severe pain relief
Unapproved Use: Pregnancy, labor, delivery and lactation
Common Off-Label Use:  Labor anesthesia
Specific Warnings: "Labor and Delivery: Intravenous morphine readily passes into the fetal circulation and may result in respiratory depression in the neonate.  Naloxone and resuscitative equipment should be available for reversal of narcotic induced respiratory depression of the neonate.  In addition, intravenous morphine may reduce the strength, duration and frequency of uterine contractions resulting in prolonged labor. Epidural and intrathecal administered morphine readily passes into the fetal circulation and may result in respiratory depression of the neonate. Controlled clinical studies have shown that epidural administration has little or no effect on the relief of labor pain. Close observation should be carried out for 24 hours following exposure."
Source: Physician's Desk Reference page 563



Phenergan/Promethazine Inj
Approved Use: Nausea
Unapproved Use: Obstetrical sedation during labor
Common Off-Label Use: Sedation during labor
Documented Risks: Impaired platelet aggregation in the newborn which can cause intracranial hemorrhage in the fetus and newborn
Source: Physician's Desk Reference page 3416



Metoprolol/Lopressor/Apo-Metoprolol/Apo-Metoprolol (Type L)/Betaloc/Betaloc Durules/Lopresor/Lopresor SR/Novometoprol/Nu-Metop
Approved Use: Hypertension, Beta-Adrenergic blocker, Sympatholytic
Unapproved Use:  Pregnancy, labor, delivery
Documented Risks: Toxic at high doses causing fetal loss and decreased neonatal survival, crosses human placenta, use of some beta-blockers including metoprolol in the second and third trimesters is associated with intrauterine growth retardation and neonatal beta-blockade.
Source: Physician's Desk Reference page 606



Compazine/Prochlorperazine
Approved Use: Nausea and vomiting
Unapproved Use:  Pregnancy, labor, delivery and lactation
Common Off-Label Use: Morning sickness, hyperemesis gravidarum
Documented Risks: Prolonged jaundice, loss of neurological control of speech and hands, hyperflexia in infants, hyporeflexia in infants
Source: Physician's Desk Reference page 3077

Perhaps the main reason for the use of medications and the current  state of pregnancy and birthing care in the United States is the  misconception that "doctors know best". 

This statement represents fallacies on two levels: the first is that doctors are not taught to view birth for the natural process it is, but are indoctrinated with a medical perspective which can even include the use of practices and procedures documented as harmful to pregnant women (supine pushing, early cord clamping, restricted movement, no nutrition in labour, routine use of fetal monitoring and the list goes on) and the second is that even when they do "know better", there is no guarantee that they will "do better".

The best illustration of this point is the routine use of medications in obstetric care specifically contraindicated in pregnancy, labor, delivery and lactation.  There are many drugs that are not FDA-approved that are used on a daily basis to induce labor, or as part of the cocktail of drugs in epidural, spinal, or injectable anesthesia.  There is no documentation of their efficacy, long-term effects, delayed reactions, or impact on pregnant women or babies, including their neurological and general development. 

In short, there is no telling what these drugs could do to women and babies in their future.

The cold, hard truth is that electively choosing medications in pregnancy,  labor, and delivery exposes the mother and her unborn child to  risks that would otherwise not exist.  What mother would knowingly do such a thing?  The fact of the matter is that mothers don't know what it means to choose drugs in labor.

They are told these drugs are perfectly safe.  They've put misplaced faith in their doctor to provide quality care .  If all mothers had the true risks of these medications in pregnancy explained to them, how many would still choose elective inductions, epidurals, or c-sections?

Not many, I hope.

Giving Birth Naturally: Medications in Pregnancy