7 Interactions found for:

The following applies to the ingredients: Fluoxetine (found in Prozac)

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This drug should be used only if the potential benefit justifies the risk to the fetus, taking into account the risks of untreated depression.

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

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization.
-Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome (e.g.,. respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo/hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

Results of several epidemiological studies assessing the risk of exposure of this drug in early pregnancy have been inconsistent and not provided conclusive evidence of an increased risk of congenital malformations. Some epidemiological studies suggest an increased risk of cardiovascular malformations; however, the mechanism is unknown. Overall, data suggest that the risk of having an infant with a cardiovascular defect following maternal exposure is approximately 2 in 100 compared with 1 in 100 for the general population.

Epidemiological data have suggested that the use of SSRIs, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn. Data are not available for SNRIs.

The results of a cohort study indicated that 30% of neonates who had prolonged exposure to SSRIs in utero experienced symptoms, in a dose- response manner, of a neonatal abstinence syndrome (e.g., tremor, gastrointestinal or sleep disturbances, hypertonicity, high-pitched cry) after birth. The authors suggest that infants exposed to SSRIs should be closely monitored for a minimum of 48 hours after birth.

Data from animal studies has shown that fluoxetine may affect sperm quality. Human case reports from some SSRIs have shown this effect to be reversible. As yet, the impact of this on human fertility has not been observed.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

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: Aripiprazole (found in Abilify)

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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: Not assigned.

Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

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 developmental toxicity, including possible teratogenic effects. Congenital anomalies have been reported; however, a causal relationship has not been established. There are no controlled data in human pregnancy.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. 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.

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: http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

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 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: Fluoxetine (found in Prozac)

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Use of this drug is not recommended; however, if it is required by the mother, it is not considered a reason to discontinue breastfeeding

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for side effects such as colic, fussiness, sedation, and adequate weight gain.
-Mothers taking an SSRI during pregnancy and postpartum may have difficulty breastfeeding and may require additional breastfeeding support.

The average amount of drug in breastmilk is higher with fluoxetine than with most other SSRIs, and the long-acting active metabolite, norfluoxetine, is detectable in the serum of most breastfed infants during the first 2 months postpartum and in a few thereafter. No adverse effects on development have been reported in a few infants followed for up to one year.

It has been suggested that fluoxetine therapy may be continued during breastfeeding if it was used during pregnancy or if other antidepressants were ineffective. Alternatively, medicines with a lower excretion into breastmilk may be preferred, particularly when nursing a newborn or preterm infant.

An infant breastfed by a mother receiving oral fluoxetine therapy developed crying, sleep disturbance, watery stools, and vomiting. The infants' plasma drug levels of fluoxetine and norfluoxetine on the second day of feeding were 340 ng/mL and 208 ng/mL, respectively.

A report of ten women nursing eleven infants found that less than 10% of the dose of fluoxetine (per kg of body weight) was delivered to the nursing infant during chronic maternal therapy. Other reports from two lactating women taking fluoxetine have described milk fluoxetine and norfluoxetine concentrations to be about one-fifth to one-quarter of the serum concentrations. No adverse effects were reported in these nursing infants.

The following applies to the ingredients: Aripiprazole (found in Abilify)

Professional Content

Use is not recommended; a decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comment: The effects on lactation and in the nursing infant are unknown.

Low levels of this drug have been detected in human milk; the maternal weight-adjusted dose calculated from 2 different women provide estimates of 0.7% and 8.3%. This drug is expected to have a minimal effect on serum prolactin levels, however 2 cases of galactorrhea have been reported.