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: Lamotrigine (found in Lamictal)

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Benefit should outweigh risk

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Several prospective pregnancy exposure registries and epidemiological studies have not detected an increased frequency of major congenital malformations or a consistent pattern of malformations among women exposed to lamotrigine compared with the general population; animal studies have shown developmental toxicities at doses administered clinically.

Comments:
-Women with epilepsy who are planning to become pregnant should receive pre-pregnancy counseling; folate supplementation should be considered before conception and for the first 12 weeks of pregnancy.
-Abrupt discontinuation of anti-epileptic therapy during pregnancy is not advised as this may lead to breakthrough seizures in mother and fetus.
-Physiologic changes during pregnancy may affect drug concentrations and/or therapeutic effect; dose adjustments may be necessary to maintain clinical response.
-Women should be advised to notify their healthcare provider if they plan to start or stop oral contraceptive use or other female hormonal preparations as this may significantly affect lamotrigine drug concentrations.
-A pregnancy registry is available to provide information on the effects of in utero exposure; pregnant patients should be encouraged to enroll: North American AED Pregnancy Registry: US toll free number: 1-888-233-2334; Website: http://www.aedpregnancyregistry.org/

Animal studies have shown developmental toxicity at doses estimated to be lower than those used clinically. Pregnant rats administered 3 doses (5, 10 or 20 mg/kg) during the latter part of gestation had increased offspring mortality (including stillbirths) at all doses. The lowest effect dose for peri/postnatal developmental toxicity was less than the human dose of 400 mg/day on mg/m2 basis. Maternal toxicity was observed at the 2 highest doses. Studies in rats have shown a decrease in folic acid during pregnancy, and since this drug is a weak inhibitor of dihydrofolate reductase, there is a theoretical risk of malformation due to folate deficiency. Anti-epileptic drugs should generally be continued during pregnancy with the goal of monotherapy at the lowest effective dose, however, the risk to the mother and fetus of uncontrolled epilepsy should be considered when deciding on treatment options. Data from several international pregnancy registries have not shown an increased risk for malformations overall. The frequency of major congenital malformations was similar to estimates from the general population. The North American Antiepileptic Drug Pregnancy (NAAED) Registry has reported an increased risk of isolated oral clefts, although this finding has not been observed in other large international pregnancy registries. Several meta-analyses have not reported an increased risk of major congenital malformations following lamotrigine exposure in pregnancy compared with healthy and disease-matched controls. No patterns of specific malformation types were observed. As with other antiepileptic drugs, decreased lamotrigine concentrations have been reported during pregnancy with a return to pre-pregnancy concentrations after delivery. Appropriate clinical management should include monitoring drug concentrations and adjusting doses as indicated. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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.

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: Lamotrigine (found in Lamictal)

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Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Adverse reactions have occasionally been reported in breastfed babies, but long-term exposure does not appear to affect infant growth and development.
-Breastfed infants should be carefully monitored for side effects; serum levels may be measured to rule out toxicity.
-If infant rash occurs, breastfeeding should be discontinued until cause can be established.

Drug concentrations in human milk may be as high as 50% of the maternal serum levels. Neonates are at risk for high plasma levels due to plasma protein binding being relatively low and decreased ability to clear drug (immaturity of glucuronidation capacity). Additionally, similar to other antiepileptic drugs, the maternal dose should generally be reduced after delivery to the pre-pregnancy dosage, and failure to reduce dose may lead to higher milk concentrations. Apnea, rash, drowsiness, and poor sucking have been reported in breastfed infants. If an adverse event occurs, a serum level can be measured to rule out toxicity. Consider monitoring platelet counts and liver function. Breastfeeding should be discontinued in infants with lamotrigine toxicity