5 Interactions found for:

The following applies to the ingredients: Omega-3 Polyunsaturated Fatty Acids (found in Fish Oil)

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Use is recommended only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Comments:
-There is insufficient data on use in pregnancy to identify drug-associate risks for major birth defects, miscarriage, or adverse fetal or maternal outcomes.
-Animal studies of dams given oral omega-3-acid ethyl esters from mating through lactation did not show adverse reproductive or developmental effects at 5 times the maximum recommended human dose (MRHD).
-Animal studies of oral dosing at clinically relevant doses during organogenesis did not show teratogenicity.
-There is no official RDA for omega-3 fatty acids during pregnancy, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1400 mg per day should be adequate during lactation.
-Pregnant women may not consume adequate amounts of omega-3 fatty acids from their diet due to recommendations to limit fish consumption to no more than twice weekly (due to mercury content of fish).

Animal studies of oral administration from 2 weeks prior to mating through lactation showed no adverse effects at 5 times the recommended human dose (MRHD). A dose ranging study of oral administration from 2 weeks prior to mating to postpartum day 7 showed a 20% reduction in live births and a 40% reduction in pup survival to postnatal day 4 at or above 3000 mg/kg/day (7 times the MRHD). Oral doses up to 14 times the MRHD (a maternotoxic dose) administered during organogenesis showed no fetal adverse effects. Animals given oral doses up to 5 times the MRHD from gestation day 14 through lactation day 21 showed no adverse effects. Skeletal malformations and reduced fetal growth were seen at maternally toxic doses (4 times the MRHD) and embryolethality occurred at 7 times the MRHD in rabbits. There are no controlled data in human pregnancy. Adequate omega-3 fatty acid intake during pregnancy may reduce preterm birth, increase birth length, weight, and head circumference, improve cognitive and visual development, and reduce risk of allergies. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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: Atorvastatin

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According to some authorities: Use is contraindicated during pregnancy or in patients of childbearing potential not using contraception.

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

Risk summary: Based on its mechanism of action, this drug may cause fetal harm when administered during pregnancy.
-Available data on the use of statins in pregnant women have not identified a drug-related risk of major congenital malformations and are insufficient to inform a drug-related risk of miscarriage.

Comments:
-If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient should be apprised of the potential harm to the fetus.
---According to some authorities: Alternatively, the ongoing needs of the individual patient should be considered.
-According to some authorities: Patients of childbearing potential should use effective contraception during therapy; this drug should be used in patients of childbearing potential only when they are highly unlikely to conceive and have been informed of the potential.

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity; however, at maternally toxic doses, increased postimplantation loss and decreased fetal body weights have been observed. No adverse developmental effects were observed in pregnant rats or rabbits administered oral doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg (based on body surface area [mg/m2]); in rats administered this drug during gestation and lactation, decreased postnatal growth and development delay were observed at doses at least 6 times the MRHD. This drug crosses the rat placenta and reaches levels in the fetal liver equivalent to that of maternal plasma. A study of statin-exposed pregnant women compared to controls did not find a significant teratogenic effect from maternal use of statins in the first trimester, after adjusting for potential confounders. Rare cases of congenital anomalies after intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy.

Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Because this drug decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol, it may cause fetal harm when used during pregnancy.

Treatment of hyperlipidemia is not generally necessary during pregnancy. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term primary hypercholesterolemia therapy for most patients.

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: Atorvastatin

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Until more data are available, an alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug.
-According to some authorities: Use is contraindicated.

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

Comments:
-Another drug in this class is excreted into human milk.
-Statins (including this drug) decrease synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; they may cause harm to the breastfed infant.
-The effects in the nursing infant are unknown; based on the mechanism of action, there is the potential for serious adverse reactions in nursing infants.

Due to a concern over disruption of infant lipid metabolism, it is generally agreed that women taking a statin should not breastfeed; however, others have argued that children homozygous for familial hypercholesterolemia are treated with statins starting at 1 year of age, statins have low oral bioavailability, and risks to the breastfed infant are low. Some evidence indicates that this drug can be taken by nursing mothers with no obvious developmental problems in their infants.

In cases of patients with homozygous familial hypercholesterolemia, 6 patients breastfed 11 infants after restarting statin therapy postpartum; the specific statin was not reported, but most of the women on statin therapy were using this drug (40 or 80 mg/day). Normal early child development was reported for all offspring; children started school at the appropriate age with no learning difficulties reported.

The following applies to the ingredients: Omega-3 Polyunsaturated Fatty Acids (found in Fish Oil)

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Safety has not been established; use is not recommended.

Excreted into human milk: Yes

Comments:
-There is no information regarding this drug on the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Higher omega-3 fatty acid levels have been seen in lactating patients receiving oral omega-3 fatty acid supplementation.
-Infant needs for docosahexaenoic acid (DHA) is approximately 70 to 80 mg per day.
-There is no official RDA for omega-3 fatty acids during lactation, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1300 mg per day should be adequate during lactation.