5 Interactions found for:

The following applies to the ingredients: Lamotrigine (found in Lamictal)

Professional Content

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: Quetiapine (found in Seroquel)

Professional Content

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Comments:
-A pregnancy exposure registry is available.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Animal studies have revealed evidence of embryo-fetal toxicity. Limited published human data have reported no major malformations associated with use during pregnancy. There are no controlled data in human pregnancy.

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. This drug is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

To monitor the outcomes of pregnant women exposed to atypical antipsychotics, a National Pregnancy Registry for Atypical Antipsychotics has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/atypicalantipsychotic/.

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 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: Quetiapine (found in Seroquel)

Professional Content

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:
-If this drug is used, monitor infants for drowsiness and developmental milestones.
-The American Academy of Pediatrics classified other antipsychotic agents as drugs whose effect on the nursing infant is unknown but may be of concern.

Based on milk samples from a mother who received 200 mg daily throughout pregnancy and postpartum, it is estimated that an exclusively breastfed infant would receive 0.09% to 0.43% of a weight-adjusted maternal dose. Limited long-term follow-up of infants exposed to this drug during breastfeeding have shown generally normal development. However, due to the potential for serious adverse reactions in nursing infants and a lack of robust data, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

The following applies to the ingredients: Lamotrigine (found in Lamictal)

Professional Content

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