6 Interactions found for:

The following applies to the ingredients: Amphetamine (found in Adderall)

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Use only if the benefit justifies the risk to the fetus

US FDA pregnancy category: Not Assigned

Risk Summary: There are insufficient data to determine a drug-associated risk of major congenital malformations or miscarriages; 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/

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 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.

The following applies to the ingredients: Dextroamphetamine (found in Adderall)

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UK: Use is contraindicated during pregnancy.
AU and US: Use is not recommended during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-Infants born to mothers dependent on amphetamine drugs have an increased risk of premature delivery and low birth weight, and may experience withdrawal symptoms including dysphoria, agitation, hyperexcitabilitiy, and significant lassitude.
-Females of reproductive potential should be advised to avoid pregnancy during treatment.

Although there are no controlled data in human pregnancy, the use of amphetamine drugs during early pregnancy has been associated with an increased risk of congenital malformations. Additionally, there has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (Vater association) in an infant whose mother took this drug with lovastatin during the first trimester of pregnancy.

Some animal studies have revealed evidence of embryotoxicity, teratogenicity, and reproductive toxicity. Animal data also showed developmental delays, behavioral sensitization, and increased motor activity in animal offspring due to prenatal exposures at dose levels comparable to human therapeutic dose levels.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

The following applies to the ingredients: Amphetamine-Dextroamphetamine (found in Adderall)

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Use is recommended during pregnancy only if the potential benefit justifies the possible risk to the fetus.

US FDA pregnancy category: C

Comments: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight, and may experience withdrawal symptoms (e.g., dysphoria, agitation and significant lassitude).

In the enantiomer ratio present in this drug, some animal studies show amphetamine had no apparent effects on embryofetal morphological development or survival while other data offspring effects (e.g., decreased survival, increased locomotor activity, reduced body weight) in addition to maternal effects (e.g., hyperactivity and decreased weight gain). Animal studies also reveal long-term neurochemical and behavioral effects with exposure to amphetamine (d- or d-,l-isomers) at doses similar to those used clinically. There has been one report of severe congenital bony deformity, trachea-esophageal fistula, and anal atresia (vater association) in an infant whose mother took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. There are no reported effects on fertility.

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.

The following applies to the ingredients: Zolpidem (found in Ambien)

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

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: The data do not report a clear association between use of this drug and major birth defects.

Comments:
-A syndrome of hypothermia, hypotonia, respiratory depression and difficulty feeding may occur in in infants of mothers administered this drug in the late phase of pregnancy or during childbirth.
-Withdrawal symptoms may occur in neonates whose mothers were taking sedative-hypnotics late in pregnancy.

Cases of severe neonatal respiratory depression have been reported when this drug was used at the end of pregnancy, especially when used with other central nervous system (CNS) depressants. Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may be at risk for developing physical dependence and withdrawal symptoms in the postnatal period. Additionally, neonatal flaccidity also has been reported in infants born to mothers who received sedative/hypnotic drugs during pregnancy.

Animal studies have revealed no evidence of teratogenicity or fertility impairment, but adverse effects including incomplete fetal skeletal ossification and increased embryo-fetal death.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

The following applies to the ingredients: Amphetamine (found in Adderall)

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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.

The following applies to the ingredients: Dextroamphetamine (found in Adderall)

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UK: Use is contraindicated during breastfeeding.
AU and US: Breastfeeding is not recommended during treatment.

Excreted into human milk: Yes

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

-Blood levels of this drug in 3 breastfed infants were up to 14% of the maternal plasma level.
-Four breastfed infants whose mothers took an average dose of 18 mg per day of this drug had no adverse effects and showed normal progress with weights between the 10th and 75th percentiles.
-In a study of 20 postpartum women, this drug 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 produced a sustained suppression of serum prolactin by 40%.

The following applies to the ingredients: Amphetamine-Dextroamphetamine (found in Adderall)

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Breastfeeding is not recommended during treatment.

Excreted into human milk: Yes

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

Level 2:
-The urinary excretion in 2 breastfed infants whose mothers took amphetamine 20 to 35 mg/day ranged from 0.1% to 2.1% of the mothers' excretion; these infants showed no signs of abnormal development.
-Dextroamphetamine blood levels in 3 breastfed infants were up to 14% of the maternal plasma level.
-Four breastfed infants whose mothers took an average dose of 18 mg/day dextroamphetamine had normal progress, no adverse effects, and weights between the 10th and 75th percentiles.
-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%.

The following applies to the ingredients: Zolpidem (found in Ambien)

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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:
-Some experts state that this drug should be used with caution.
-Due to the low levels of this drug in breastmilk and its short half-life, amounts ingested by nursing infants are small and would not be expected to cause any adverse effects in these infants.
-The American Academy of Pediatrics considers this drug to be compatible with breastfeeding.
-Some experts recommend monitoring breastfed infants for hypotonia, respiratory depression, and sedation.

After a single, 20 mg oral dose was administered to 5 nursing mothers (who were 3 to 4 days postpartum), breastmilk collected at 3 hours contained between 0.004% to 0.019% of the maternal dosage; the drug was undetectable (drug levels less than 0.5 mcg/L) in the breastmilk 13 to 16 hours after the dose was given.

In animal models, administration of this drug during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose tested.