6 Interactions found for:

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: Semaglutide (found in Ozempic)

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Benefit should outweigh risk

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

Risk summary: Available data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other maternal or fetal outcomes; based on animal data, there may be potential risks to the fetus from exposure during pregnancy. Additionally weight loss offers no benefit to a pregnant patient and may cause fetal harm.

Comments:
-Poorly controlled diabetes during pregnancy is associated with both maternal and fetal risks.
-When pregnancy is recognized for a women on Wegovy, this drug should be discontinued and the patient should be advised of the risk to a fetus.
-Women of childbearing potential should be encouraged to use contraception during therapy; if pregnancy is desired, stop treatment at least 2 months prior to a planned pregnancy due to its long washout period.
-A pregnancy registry has been created to monitor pregnancy outcomes in women exposed to semaglutide (Wegovy) during pregnancy; pregnant women exposed to Wegovy and healthcare providers are encourage to contact Novo Nordisk at 1-800-727-6500.

Studies in pregnant rats have shown embryofoetal mortality, structural abnormalities, and alterations to growth when administered during organogenesis at maternal exposures below the maximum recommended human dose (MRHD). Early pregnancy losses and structural abnormalities were observed in rabbits at doses below the MRHD. In cynomolgus monkeys, early pregnancy losses and structural abnormalities were observed at exposures of 10-fold or higher that of the MRHD. In rabbits and monkeys, these finding coincided with marked maternal body weight loss. Salcaprozate sodium (SNAC), an absorption enhancer in the oral tablet has been shown to cross the placenta and reach fetal tissue in rats. Administration of SNAC to pregnant rats has shown an increase in number of stillbirths and a decrease in pup viability. There are no adequate and well-controlled studies in pregnant women.

Clinical considerations:
-Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. In the US, the estimated background risk of major birth defects in women with pregestational diabetes with an HbA1c greater than 7 is 6% to 10%; in women with pregestational diabetes and a HbA1c greater than 10, this risk has been reported as 20% to 25%.
-Appropriate weight gain based on pre-pregnancy weight is recommended for all pregnant patients because of the obligatory weight gain that occurs in maternal tissues 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: 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: Semaglutide (found in Ozempic)

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Oral Administration: Not recommended
Subcutaneous Administration: Benefit should outweigh risk

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

Comments:
-Oral tablets: Breastfeeding is not recommended with maternal use of the oral tablet due to the possible accumulation of the absorption enhancer (salcaprozate sodium) in breastfed infant; if therapy is necessary, the subcutaneous injection should be used.
-Subcutaneous injection: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.
-Some authorities advise against semaglutide use during lactation as a risk to the breastfed child cannot be excluded.

Subcutaneous formulation: In lactating rats, this drug was detected in milk at levels 3 to 12-fold lower than maternal plasma. There are no data on the presence of this drug in human milk, the effects on milk production, or the effects on the breastfed infant. It is assumed that because this drug is a peptide molecule and is over 99% protein bound, if excreted, the amount in milk would be low. Additionally, it is believed that if excreted in milk, infant absorption would be unlikely as it would probably be destroyed in the infant's gastrointestinal tract.

Oral Tablet: Salcaprozate sodium (SNAC) is present in the oral formulation as an absorption enhancer. SNAC and/or its metabolites have been found in concentrated quantities in the milk of lactating rats. There are no data in the presence of SNAC in human milk, however, the enzyme needed to clear SNAC (UGT2B7) is lower in infants compared to adults and therefore higher SNAC plasma levels may occur in breastfed infants. The potential for serious adverse reactions due to accumulation of SNAC are unknown.