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.  This practice is common in obstetrics in that pregnant women cannot participate in drug trials to determine guidelines for safe use. In some instances, the manufacturers and FDA have provided detailed warnings prohibiting the use of such drugs in pregnancy, labor and lactation, all of which are ignored by physicians on a daily basis.

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.

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

Elective use of medications in pregnancy, labor, and delivery exposes the mother and her unborn child to risks that would otherwise not exist. Unfortunately, most women do not know to ask about the safety of these drugs, as they assume their safety has been assured. In some cases, women are even told these drugs are perfectly safe.

For these reasons, it is vital to be an informed consumer, asking questions surrounding any and all procedures during pregnancy and childbirth to preserve the safety and well-being of both mother and child.

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Page Last Modified by Catherine Beier, MS, CBE