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Lorazepam Pregnancy and Breastfeeding Warnings

Lorazepam is also known as: Ativan, Lorazepam Intensol

Medically reviewed on September 28, 2016

Lorazepam Pregnancy Warnings

Animal studies have shown occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia). There are no adequate studies in pregnant women.

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 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.

Use should be avoided.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: This drug may increase the risk of fetal malformations and/or withdrawal symptoms.

Comments:
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.
-There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been taking benzodiazepines late in pregnancy.
-Glucuronidation of this drug may competitively inhibit the conjugation of bilirubin, leading to hyperbilirubinemia in neonates.

See references

Lorazepam Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines.
-Infants of lactating mothers should be observed for pharmacological effects (including sedation and irritability).
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern if exposure is prolonged.

See references

References for pregnancy information

  1. "Product Information. Ativan (lorazepam)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Brophy GM, Bell R, Claasen J, et.al "Guidelines for the Evaluation and Management of Status Epilepticus." Neurocrit Care 17 (2012): 3-23
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  4. "Product Information. Ativan (lorazepam)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  5. 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.

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