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Propranolol Pregnancy and Breastfeeding Warnings

Brand names: Hemangeol, Inderal, Inderal LA, Inderal XL, InnoPran XL

Propranolol Pregnancy Warnings

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Beta blockers may cause decreased placental perfusion, fetal and neonatal bradycardia, and hypoglycemia.

Propranolol has been used safely to treat a variety of conditions during pregnancy, including hypertension and pheochromocytoma in the mother, and tachyarrhythmias in both the mother and fetus. There are a number of abnormalities associated with the use of propranolol during pregnancy, but many of these may be attributable to underlying diseases. These abnormalities include some signs of beta-blockade, such as bradycardia, hypoglycemia, and respiratory depression. Other abnormalities that may be due to propranolol include intrauterine growth retardation, small placentas, polycythemia, thrombocytopenia, and hypocalcemia.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA 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.

See references

Propranolol Breastfeeding Warnings

Propranolol milk to maternal plasma ratios as high as 1.5 has been reported. While no adverse effects in the nursing infant have been reported, experts advise monitoring the infant for signs and symptoms of beta-blockade and to schedule feedings at least three hours after maternal propranolol administration.

Use is not recommended.

Excreted into human milk: Yes

Comments: Propranolol levels in breast milk are low and would not be expected to cause any adverse effects in breastfed infants.

See references

See also

References for pregnancy information

  1. O'Hare MF, Kinney CD, Murnaghan GA, McDevitt DG. Pharmacokinetics of propranolol during pregnancy. Eur J Clin Pharmacol. 1984;27:583-7.
  2. Levitan AA, Manion JC. Propranolol therapy during pregnancy and lactation. Am J Cardiol. 1973;32:247.
  3. Taylor EA, Turner P. Anti-hypertensive therapy with propranolol during pregnancy and lactation. Postgrad Med J. 1981;57:427-30.
  4. Product Information. Inderal (propranolol). Wyeth-Ayerst Laboratories. 2001;PROD.
  5. O'Connor PC, Jick H, Hunter JR, Stergachis A, Madsen S. Propranolol and pregnancy outcome. Lancet. 1981;2:1168.
  6. Caldroney RD. Beta-blockers in pregnancy. N Engl J Med. 1982;306:810.
  7. Livingstone I, Craswell PW, Bevan EB. Propranolol in pregnancy three year prospective study. Clin Exp Hypertens B. 1983;2:341-50.
  8. Eliahou HE, Silverberg DS, Reisin E, Romem I, Mashiach S, Serr DM. Propranolol for the treatment of hypertension in pregnancy. Br J Obstet Gynaecol. 1978;85:431-6.
  9. Redmond GP. Propranolol and fetal growth retardation. Semin Perinatol. 1982;6:142-7.
  10. Frishman WH, Chesner M. Beta-adrenergic blockers in pregnancy. Am Heart J. 1988;115:147-52.
  11. Belpaire FM, Wynant P, Vantrappen P, Dhont M, Verstraete A, Bogaert MG. Protein binding of propranolol and verapamil enantiomers in maternal and foetal serum. Br J Clin Pharmacol. 1995;39:190-3.
  12. Page RL. Treatment of arrhythmias during pregnancy. Am Heart J. 1995;130:871-6.
  13. Product Information. InnoPran XL (propranolol). Reliant Pharmaceuticals LLC. 2003.
  14. Cerner Multum, Inc. UK Summary of Product Characteristics.
  15. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf 2007.
  16. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Roberts RJ, Blumer JL, Gorman RL, et al. American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk. Pediatrics. 1989;84:924-36.
  2. Levitan AA, Manion JC. Propranolol therapy during pregnancy and lactation. Am J Cardiol. 1973;32:247.
  3. Bauer JH, Pape B, Zajicek J, Groshong T. Propranolol in human plasma and breast milk. Am J Cardiol. 1979;43:860-2.
  4. Taylor EA, Turner P. Anti-hypertensive therapy with propranolol during pregnancy and lactation. Postgrad Med J. 1981;57:427-30.
  5. Product Information. Inderal (propranolol). Wyeth-Ayerst Laboratories. 2001;PROD.
  6. Product Information. InnoPran XL (propranolol). Reliant Pharmaceuticals LLC. 2003.
  7. Cerner Multum, Inc. UK Summary of Product Characteristics.
  8. Cerner Multum, Inc. Australian Product Information.
  9. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.

Further information

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

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