7 Interactions found for:

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

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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: Pravastatin

Professional Content

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments:
-This drug should only be used in women of childbearing potential who are highly unlikely to conceive and have been informed of the potential hazards.
-If the patient becomes pregnant while taking this drug, therapy should be immediately discontinued and the patient should be apprised of the potential hazard to the fetus.
-Use of adequate methods of contraception should be encouraged.

Animal studies have failed to reveal evidence of teratogenicity, however, oral gavage doses of 4, 20, 100, 500, and 1000 mg/kg/day given to rats from gestation day 7 through 17 increased mortality of offspring and skeletal anomalies and developmental delays were observed at 100 mg/kg/day (10 times the human exposure of 80 mg/day). Rare cases of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hypercholesterolemia therapy.

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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

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

Professional Content

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: Pravastatin

Professional Content

Use is contraindicated.

Excreted into human milk: Yes (in small amounts)

Comments:
-This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

The excretion of this drug into breast milk was evaluated in 11 women following oral administration of 20 mg orally twice a day for a total of 5 doses. The maximum concentrations of this drug and its major metabolite in milk following the last dose averaged 3.9 mcg/L and 2.1 mcg/L, respectively. Using these peak levels, a fully breastfed infant would receive a maximum of 900 mcg/kg per day or about 1.4% of the maternal weight adjusted dose.