6 Interactions found for:

The following applies to the ingredients: Gabapentin

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: Dapagliflozin (found in Farxiga)

Not recommended during the second and third trimesters of pregnancy

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

Risk Summary: There is insufficient data in pregnant women to determine a drug-associated risk for major birth defects or miscarriage; animal data has shown adverse renal effects with this drug during the renal development period which corresponds to the late second and third trimesters of human pregnancy.

Comments:
-When pregnancy is detected, this drug should be discontinued.
-Poorly controlled diabetes during pregnancy increases maternal and fetal risks for adverse outcomes.

Rat studies have shown adverse renal changes when this drug was administered during the period of renal development corresponding to late second and third trimesters of human development. Renal pelvic and tubule dilations, not fully reversible (within a 1 month recovery period), were observed at all doses studied including the lowest which provided an exposure 15-times the 10 mg clinical dose. There are no adequate well-controlled studies in pregnant women.

Clinical considerations: The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20% to 25% in women with HbA1c greater than 10%. Poorly controlled diabetes during pregnancy increases maternal risks for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; and fetal risks for for major birth defects, stillbirth, and macrosomia related morbidity. Insulin is generally recommended as the drug of choice 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

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: Dapagliflozin (found in Farxiga)

Not recommended

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

Comment: This drug is not recommended while breastfeeding due to the potential for serious adverse reactions in breastfed infants.

This drug has been found in rat milk at a milk to plasma ratio of 0.49 which means this drug and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. Although, it is unknown if this drug is excreted into human milk, there is potential for serious harm to the developing kidney if the breastfed infant is exposed. Human kidney maturation occurs during the first 2 years of life. Juvenile rats directly exposed to this drug have shown renal pelvic and tubular dilations during maturation. The long-term functional consequences of these effects are unknown. Additionally,decreased weight gain has been associated with lactational exposure in juvenile rats.