6 Interactions found for:

The following applies to the ingredients: Omeprazole

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Risk Summary: Epidemiologic studies have demonstrated that major malformative risks with use in pregnant patients are unlikely.

Comment: Some experts recommend that use is considered acceptable.

Animal models have revealed evidence of dose-related increases in embryolethality, fetal resorptions, and pregnancy disruptions when animal models were given this drug during organogenesis. Major fetal malformations were not frequently observed in animal models. Embryofetal and postnatal developmental toxicities were observed in offspring of parents given at least 3.4 times an oral human dose of 40 mg.

Embryofetal toxicity is associated with maternally toxic doses given throughout gestation as well as in high doses given to males prior to mating.

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: Atorvastatin (found in Lipitor)

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: Omeprazole

Use is not recommended.

Excreted into human milk: Yes

Comments:
-This drug is associated with tumorigenicity in animal models, and may suppress gastric acid secretion in the nursing infant.
-The American Academy of Pediatrics state that this drug should be avoided until additional studies can confirm the safe use of this drug during breastfeeding.

In animal models, decreased postpartum offspring growth rates were observed when this drug was administered during late gestation and throughout lactation at oral doses of at least 138 mg/kg/day and IV doses of 3.2 mg/kg/day.

The following applies to the ingredients: Atorvastatin (found in Lipitor)

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.