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Epinephrine Pregnancy and Breastfeeding Warnings

Epinephrine is also known as: Adrenaclick, Adrenalin, Adrenalin Chloride, Ana-Guard, Asthmahaler, Auvi-Q, Bronchial Mist with Pump, Bronitin, Bronkaid Mist, EPIsnap, Epi EZ Pen, EpiPen, EpiPen 2-Pak, EpiPen Auto-Injector, EpiPen JR 2-Pak, EpiPen JR Auto-Injector, EpiPen Jr, Medihaler-Epi, Primatene Mist, Sus-Phrine Injection, Symjepi, Twinject

Medically reviewed by Drugs.com. Last updated on Aug 27, 2021.

Epinephrine Pregnancy Warnings

Use is considered acceptable during pregnancy; use with caution during labor and delivery; avoid use during the second stage of labor.

AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned

Risk summary: Prolonged experience with use in pregnancy over several decades, based on published literature, does not identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are risks to the mother and fetus with use during labor or delivery.

Comments:
-Use with caution during labor and delivery; avoid use during second stage of labor.
-Avoid use in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
-According to some authorities, this drug is considered first choice for anaphylaxis treatment during pregnancy; use in the same manner as for non-pregnant patients.
-Patients should seek immediate medical care in addition to using this medication.
-Animal reproduction studies of subcutaneous administration of this during organogenesis resulted in adverse developmental effects (including gastroschisis, embryonic lethality, and delayed skeletal ossification) at doses approximately 2 times the maximum recommended daily intramuscular, subcutaneous, or intravenous dose.

Clinical considerations:
-Anaphylaxis during pregnancy can be catastrophic, potentially leading to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, the fetus or neonate.
-The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries.
-Management of anaphylaxis during pregnancy is similar to management in the general population.
-This drug is the first line-medication of choice for treatment of anaphylaxis; use in the same manner in pregnant and non-pregnant patients.
-Patients should seek immediate medical or hospital care in conjunction with use of this drug.
-Hypotension associated with septic shock in pregnancy is a medical emergency which can be fatal if untreated.
-Delaying treatment in pregnancy with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality.
-Life-sustaining therapy should not be withheld due to potential concerns regarding the effects on the fetus.

Labor or Delivery:
-This drug usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor.
-Avoid use during the second stage of labor.
-In dosage sufficient to reduce uterine contractions, this drug may cause a prolonged period of uterine atony with hemorrhage.
-Avoid use in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
-Although this drug may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia.

In an animal embryofetal development study with dosing during organogenesis (on days 3 to 5, 6 to 7, or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis) at doses approximately 15 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for 2 to 3 days). Animals treated on days 6 to 7 had decreased implantations. In an embryofetal development study subcutaneous administration on gestation days 6 to 15 showed teratogenicity, embryonic lethality, and delays in skeletal ossification at approximately 3 times the maximum recommended intramuscular, subcutaneous, or intravenous dose. These effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose. In an embryofetal development study with subcutaneous administration during organogenesis (from gestation days 7 to 10) litter size was reduced and delayed skeletal ossification was seen at doses approximately 2 times the maximum recommended intramuscular, subcutaneous, or intravenous dose. There are no controlled data in human pregnancy.

Anaphylaxis during pregnancy may lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death for the mother and the fetus/neonate. Anaphylaxis during pregnancy is estimated at 3 per 1000 deliveries.

Use with caution during labor and delivery; while this drug improves maternal hypotension associated with anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Use should be avoided during the second stage of labor as this drug may reduce uterine contractions and cause a prolonged period of uterine atony with hemorrhage.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Epinephrine Breastfeeding Warnings

High IV doses may reduce milk production and milk letdown. Studies in non-nursing subjects and women with hyperprolactinemia who received an IV infusion of this drug demonstrated decreased serum prolactin concentrations. Animal studies indicate that intra-arterial administration can decrease serum oxytocin and inhibit milk ejection. However, due to its poor oral bioavailability and short half-life, any amount of this drug present in milk is unlikely to affect the infant.

Some authorities consider this drug a first-line agent for anaphylaxis; other experts do not recommend use during breastfeeding

Excreted into human milk: Yes

Comments:
-There is no information regarding this drug on the effects on a breastfed infant, or effects on milk production.
-Due to this drugs poor oral bioavailability and short half-life, exposure is expected to be very low in the breastfed infant.
-According to some authorities, this drug is considered first choice for anaphylaxis treatment during breastfeeding; use in the same manner as for non-breastfeeding patients.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Adrenalin (EPINEPHrine)." A-S Medication Solutions, Chicago, IL.
  4. "Product Information. Adrenaclick Two-Pack (EPINEPHrine)." Amedra Pharmaceuticals LLC, Middlesex, NJ.
  5. "Product Information. Auvi-Q (EPINEPHrine)." sanofi-aventis, Bridgewater, NJ.
  6. "Product Information. Epinephrine (EPINEPHrine)." Physicians Total Care, Tulsa, OK.
  7. "Product Information. EpiPen (EPINEPHrine)." Dey Laboratories, Napa, CA.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Adrenalin (EPINEPHrine)." A-S Medication Solutions, Chicago, IL.
  3. "Product Information. Adrenaclick Two-Pack (EPINEPHrine)." Amedra Pharmaceuticals LLC, Middlesex, NJ.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. EpiPen (EPINEPHrine)." Dey Laboratories, Napa, CA.
  6. "Product Information. Epinephrine (EPINEPHrine)." Physicians Total Care, Tulsa, OK.
  7. "Product Information. Auvi-Q (EPINEPHrine)." sanofi-aventis, Bridgewater, NJ.
  8. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.