7 Interactions found for:

The following applies to the ingredients: Aspirin (found in Aspirin Low Strength)

100 mg/day or less: Use with caution
Greater than 100 mg/day: NSAIDs should be avoided at 20 weeks gestation and later

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

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-Guidelines recommend low-dose aspirin prophylaxis (e.g., 81 mg/day) in women at high risk of preeclampsia; initiation should be between 12- and 28-weeks gestation (optimally before 16 weeks) and continued until delivery; the use aspirin at 81 mg/day dose for certain pregnancy-related conditions at any point in pregnancy is an exception to the FDA recommendations to avoid use of NSAIDs in pregnancy at 20 weeks or later.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.
-NSAID use is not recommended in women attempting to conceive as it may impair female fertility.

In animals, prostaglandin synthesis inhibitors have been shown to increase pre and post-implantation loss and embryo-fetal lethality. Epidemiologic studies suggest increased risk of miscarriage, cardiac malformations, and gastroschisis when used early in pregnancy; the absolute risk of cardiovascular malformations increased from less than 1% to up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy.

Aspirin (acetylsalicylic acid) is a NSAID that inhibits cyclooxygenase (COX) isoenzymes 1 and 2. The effect on COX isoenzymes is dose-dependent with lower doses (60 to 150 mg) inhibiting platelet synthesis while higher doses results in inhibition of both COX-1 and COX-2 blocking all prostaglandin production. Low-dose aspirin has been used during pregnancy to prevent or delay the onset of preeclampsia. Daily low-dose aspirin has been shown to be associated with a low likelihood of serious maternal, or fetal complications. Guidelines should be consulted for specific use.

During the third trimester of pregnancy, administration of COX-1 and COX-2 blocking nonsteroidal anti-inflammatory drugs (NSAIDs) may cause premature closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, pulmonary hypertension, and prolongation of bleeding time. There are no controlled data in human pregnancy.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later; the use aspirin at 81 mg/day dose for certain pregnancy-related conditions at any point in pregnancy is an exception. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.

Administration during labor and delivery is not recommended as the onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child.

A study of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy--CLASP) did "not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR." In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery.

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: 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: Aspirin (found in Aspirin Low Strength)

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-This drug appears compatible with breastfeeding for occasional use and in low doses for anti-thrombosis; however, repeated use in normal doses and long-term use, especially in high doses should be avoided.
-Breastfed infants should be monitored for hemolysis, prolonged bleeding time, and metabolic acidosis.

This drug is excreted in human milk in small amounts. Low dose aspirin (75 to 162 mg/day) is considered by many experts to be compatible with breastfeeding. Peak milk salicylate levels have been reported up to 9 hours after maternal dosing with peak levels generally occurring 2 to 6 hours after nursing. Large doses may result in rashes, platelet abnormalities, and bleeding in nursing infants. Long-term, high dose maternal use was associated with 1 case of metabolic acidosis in breastfed infant. The risk for Reye's syndrome in infants with viral infections is unknown.

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.