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Amphetamine Pregnancy and Breastfeeding Warnings

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

Amphetamine Pregnancy Warnings

The limited published data in human pregnancy is insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal studies, no effects on morphological development were seen but long-term neurochemical and behavioral effects (e.g., learning and memory deficits, altered locomotor activity, changes in sexual function) have been reported at clinically relevant doses. Fetal malformations and death as well as severe maternal toxicity were observed in animals following parenteral administration of d-amphetamine doses approximately 6 times the MRHD or greater. Animal studies with d- to l-amphetamine ratio of 3.2 to 1 did not reveal any effects on fertility or early embryonic development at doses of approximately 5 times the MRHD. 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 is recommended only if the benefit justifies the risk to the fetus. US FDA pregnancy category: C (immediate-release oral tablet) US FDA pregnancy category: Not Assigned (extended-release oral suspension) 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. -This drug and others within the amphetamine class may cause vasoconstriction of placental blood vessels and increase the risk for intrauterine growth restriction.

See references

Amphetamine Breastfeeding Warnings

Breastfeeding is not recommending during treatment. Excreted into human milk: Yes Comments: -The effect of amphetamine in milk on the neurological development of the breastfed infant has not been well studied. -Large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established.

-The urinary excretion in a breastfed infant whose mother took amphetamine 35 mg daily and exclusively breastfed for 6 months ranged from 1.9% to 2.1% of the mother's excretion; this infant experienced no adverse reactions and grew normally, and the mother experienced no adverse effect on milk production. -The urinary excretion in a breastfed infant whose mother took racemic amphetamine 5 mg four times daily ranged from 0.1% to 0.3% of the mother's excretion; this infant showed no signs of abnormal development during the first 2 years of life. -In a study of 20 postpartum women, dextroamphetamine reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose of dextroamphetamine produced a sustained suppression of serum prolactin by 40%.

See references

References for pregnancy information

  1. "Product Information. Evekeo (amphetamine)." Arbor Pharmaceuticals, Atlanta, GA.
  2. "Product Information. Dyanavel XR (amphetamine)." Tris Pharma Inc, Monmouth Junction, NJ.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

References for breastfeeding information

  1. "Product Information. Dyanavel XR (amphetamine)." Tris Pharma Inc, Monmouth Junction, NJ.
  2. "Product Information. Evekeo (amphetamine)." Arbor Pharmaceuticals, Atlanta, GA.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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