Skip to Content

Amphetamine Pregnancy and Breastfeeding Warnings

Amphetamine is also known as: Adzenys ER, Adzenys XR-ODT, Dyanavel XR, Evekeo, Evekeo ODT

Medically reviewed by Drugs.com. Last updated on Mar 5, 2018.

Amphetamine Pregnancy Warnings

In animal studies, no effects on morphological development were seen in rats and rabbits exposed to doses 2 and 12 times the maximum recommended human dose (MRHD) during organogenesis, respectively. However, long-term neurochemical and behavioral effects (e.g., learning and memory deficits, altered locomotor activity, changes in sexual function) have been reported in published animal development studies at clinically relevant doses. Fetal malformations and death as well as severe maternal toxicity were observed in mice following parenteral administration of d-amphetamine doses approximately 10 times the MRHD. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mother's dependent on amphetamines. This drug and others within the amphetamine class may cause vasoconstriction of placental blood vessels and increase the risk for intrauterine growth restriction. There are no controlled human data in pregnancy.

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 women despite potential risks.

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 only if the benefit justifies the risk to the fetus

US FDA pregnancy category: C (immediate-release oral tablet; extended-release ODT)
US FDA pregnancy category: Not Assigned (extended-release oral suspension)

Risk Summary: There are limited published data on use in human pregnancy; long-term neurochemical and behavioral effects have been reported in published animal developmental studies using clinically relevant doses of amphetamine.

Comments:
-Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight; these infants should be monitored for feeding difficulties, irritability, agitation, excessive drowsiness and other withdrawal symptoms.
-Pregnancy exposure registry monitors pregnancy outcomes in women exposed to psychostimulants during pregnancy; National Pregnancy Registry for Psychostimulants 1-866-961-2388 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/

See references

Amphetamine Breastfeeding Warnings

Not recommended

Excreted into human milk: Yes

Comments:
-The effect on the neurological development of the breastfed infant has not been well studied.
-Large dosages might interfere with milk production, especially in women whose lactation is not well established.

Based on limited data, this drug is estimated to be present in human milk at approximately 2% to 13.8% of the maternal weight-adjusted dose (milk/plasma ratio 1.9 to 7.5). This drug does not appear to effect breastfeeding infants adversely in doses prescribed for medical indications, however, the effects on neurological development have not been well studied. Manufacturers recommend against breastfeeding while taking this drug due to the potential for serious adverse reactions in nursing infants. Breastfeeding should be avoided in women who are actively abusing amphetamines.

See references

References for pregnancy information

  1. "Product Information. Evekeo (amphetamine)." Arbor Pharmaceuticals, Atlanta, GA.
  2. "Product Information. Adzenys ER (amphetamine)." Neos Therepeautics, Inc, Grand Praire, TX.
  3. "Product Information. Dyanavel XR (amphetamine)." Tris Pharma Inc, Monmouth Junction, NJ.
  4. "Product Information. Adzenys XR-ODT (amphetamine)." Neos Therepeautics, Inc, Grand Praire, TX.
  5. 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 -]):

References for breastfeeding information

  1. "Product Information. Dyanavel XR (amphetamine)." Tris Pharma Inc, Monmouth Junction, NJ.
  2. "Product Information. Adzenys ER (amphetamine)." Neos Therepeautics, Inc, Grand Praire, TX.
  3. 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 -]):
  4. "Product Information. Evekeo (amphetamine)." Arbor Pharmaceuticals, Atlanta, GA.
  5. "Product Information. Adzenys XR-ODT (amphetamine)." Neos Therepeautics, Inc, Grand Praire, TX.

Further information

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

Hide