6 Interactions found for:

The following applies to the ingredients: Gabapentin

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Benefits should clearly outweigh risks

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

Risk Summary: There are no data on the developmental risks associated with use of this drug in pregnant women; in animal studies, developmental toxicity was observed at doses estimated to be similar or lower than those used clinically.

Comments:
-The risk of having a child with a congenital defect as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy; folic acid supplementation (5 mg) should be started 4 weeks prior to and continued for 12 weeks after conception.
-Women of childbearing potential should receive counseling on the risk of fetal abnormalities with use of antiepileptic drugs (AEDs) during pregnancy; AEDs should generally be continued during pregnancy utilizing monotherapy at the lowest effective dose as this has been shown to minimize risks of fetal abnormalities compared to combination AED therapy.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of developmental toxicity (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered at doses similar to, or lower than expected clinical doses. In rats, an increased incidence of hydroureter and/or hydronephrosis have been observed in offspring at all doses, the lowest dose being similar to the maximum recommended human dose on a mg/m2 basis. This drug crosses the human placenta. From the limited amount of data in human pregnancy, it is not possible to inform an associated increased risk of congenital malformations because epilepsy itself and the presence of concomitant antiepileptic medicinal products have their own risks. There are no controlled data in human pregnancy.

To provide information regarding the effects of in utero exposure to this drug, pregnant patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

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: Semaglutide (found in Ozempic)

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Noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH): This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
Type 2 diabetes mellitus: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is not recommended.
Weight management: Use is not recommended.

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

Risk summary: Limited and insufficient data are available on the use of this drug in pregnant women to inform a drug-related risk; based on animal data, this drug may cause fetal harm.

Comments:
-According to some authorities: Contraception use is recommended during therapy for patients of childbearing potential.
-This drug should be discontinued at least 2 months before a planned pregnancy due to the long half-life.
-Additionally for Wegovy:
---A pregnancy exposure registry is available.
---When a pregnancy is recognized, the patient should be apprised of the potential harm to the fetus and discontinue the drug.

Animal studies have revealed evidence of embryofetal mortality, early pregnancy losses, structural abnormalities, and growth alterations. After subcutaneous dosing in rats, rabbits, and cynomolgus monkeys during organogenesis, pharmacologically mediated maternal toxicity (reduced body weight gain and food consumption) was observed at all dose levels. In rats, reduced growth and fetal abnormalities (visceral and skeletal) were observed at the human exposure. In rabbits, early pregnancy losses and increased rates of minor fetal abnormalities (visceral and skeletal) were seen at clinically relevant exposures. In monkeys, sporadic abnormalities (vertebra, sternebra, ribs) occurred at exposures above the human exposure. Exposures at the no observed adverse effect level in all species were subclinical or only slightly higher than the plasma AUC at the maximum recommended human dose; a direct effect of this drug on the fetus cannot be excluded. Salcaprozate sodium (SNAC), an absorption enhancer in the oral tablet, has been shown to cross the placenta and reach fetal tissues in rats; SNAC was associated with increased gestation length, stillbirths, and decreased pup viability following oral dosing in pregnant rats during gestation and lactation. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Pregnant women exposed to Wegovy and health care providers are encouraged to contact the manufacturer at wegovypregnancyregistry.com.

Clinical considerations:
-Noncirrhotic MASH: There may be risks to the mother and fetus related to MASH with advanced liver fibrosis (e.g., increased risks of gestational diabetes, hypertensive complications, preterm birth, postpartum hemorrhage); the effect of this drug on these risks is unknown.
-Type 2 diabetes mellitus: Hypoglycemia and hyperglycemia occur more often during pregnancy in patients with pregestational diabetes; poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
-Weight management: Appropriate weight gain based on pre-pregnancy weight is recommended for all pregnant patients because of the obligatory weight gain that occurs in maternal tissues during pregnancy.

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: Gabapentin

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Benefits should clearly outweigh risks

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially when used in combination with other anticonvulsant or psychotropic drugs and in younger, exclusively breastfed infants.
-Some authorities suggest discontinuing nursing or discontinuing use of this drug while breastfeeding due to the potential for serious adverse reactions in the breastfed infant.

With maternal doses up to 2.1 g/day, estimated doses for fully breastfed infants are 0.2 to 1.3 mg/kg/day (equivalent to 1.3 to 3.8% of the maternal weight-adjusted dose). An expert panel has deemed this drug is an acceptable choice for refractory restless leg syndrome during lactation. Until more data becomes available, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.

The following applies to the ingredients: Semaglutide (found in Ozempic)

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Only injectable forms of this drug should be used during breastfeeding.
-According to some authorities: Use is not recommended.
-According to some authorities: Breastfeeding is not recommended during use of the oral form of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Injectable formulations: Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug. The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---According to some authorities: A risk to a breastfed child cannot be excluded.
-Oral formulations: The absorption enhancer (salcaprozate sodium [SNAC]) and/or its metabolites are present in human milk; enzyme activity involved in SNAC clearance may be lower in infants compared to adults, leading to higher SNAC plasma levels in neonates and infants.
---There is the potential for serious adverse reactions in breastfed infants due to possible SNAC accumulation.

This drug was not detectable in the milk of mothers receiving the subcutaneous formulation. Data from a lactation study with the oral tablet formulation reported drug levels below the lower limit of quantification in human milk.

In a study involving nursing mothers using subcutaneous doses of this drug, milk samples showed no measurable drug levels. If present at the detection limit, the relative infant dose was estimated to be very low. Additionally, breastfed infants of these mothers showed normal growth and development during the period of exposure through breast milk. This drug has poor oral absorption, with a maximum bioavailability of approximately 1% in adults.

Milk samples were collected (at 0, 12, and 24 hours after dosing) from 8 nursing mothers using this drug subcutaneously (0.25 to 1 mg/week); their infants (4 to 23 months old) were mixed fed, receiving breast milk for 3 to 9 weeks during maternal dosing. None of the milk samples contained any measurable drug (less than 1.7 mcg/L), and the mothers reported normal growth and development for their infants. According to author calculation, if drug milk levels were at the detection limit, the relative infant dose would have averaged 1.12%; this did not account for the poor oral absorption of the drug and maximum bioavailability of 1% in adults.