5 Interactions found for:

The following applies to the ingredients: Rosuvastatin

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Contraindicated

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

Risk Summary: Safety in pregnant women has not been established and there is no apparent benefit to use during pregnancy. Because HMG-CoA reductase inhibitors (statins) decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, this drug may cause fetal harm during pregnancy.

Comments:
-This drug should be discontinued as soon as pregnancy is recognized, and the patient should be apprised of the potential harm to the fetus.
-Women of childbearing potential should use adequate methods of contraception during therapy.

Animal studies have failed to reveal evidence of teratogenicity in doses approximating the maximum human dose of 40 mg/day. Limited published data has not shown an increased risk of major congenital malformations or miscarriage, although there have been rare reports of congenital anomalies following intrauterine exposure to other statins. Several cases of serious fetal abnormalities were reported in 2 series of 178 and 143 cases among pregnant women taking a HMG-CoA reductase inhibitor (statin) during the first trimester of pregnancy. These included limb and neurological defects, spontaneous abortions and fetal deaths. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hyperlipidemia 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 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: Dapagliflozin (found in Farxiga)

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Not recommended during the second and third trimesters of pregnancy

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

Risk Summary: There is insufficient data in pregnant women to determine a drug-associated risk for major birth defects or miscarriage; animal data has shown adverse renal effects with this drug during the renal development period which corresponds to the late second and third trimesters of human pregnancy.

Comments:
-When pregnancy is detected, this drug should be discontinued.
-Poorly controlled diabetes during pregnancy increases maternal and fetal risks for adverse outcomes.

Rat studies have shown adverse renal changes when this drug was administered during the period of renal development corresponding to late second and third trimesters of human development. Renal pelvic and tubule dilations, not fully reversible (within a 1 month recovery period), were observed at all doses studied including the lowest which provided an exposure 15-times the 10 mg clinical dose. There are no adequate well-controlled studies in pregnant women.

Clinical considerations: The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20% to 25% in women with HbA1c greater than 10%. Poorly controlled diabetes during pregnancy increases maternal risks for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; and fetal risks for for major birth defects, stillbirth, and macrosomia related morbidity. Insulin is generally recommended as the drug of choice 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: Rosuvastatin

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Contraindicated

Excreted into human milk: Yes (in low amounts)

Comments:
-Due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism, women who require treatment with this drug should not breastfeed.

The following applies to the ingredients: Dapagliflozin (found in Farxiga)

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Not recommended

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

Comment: This drug is not recommended while breastfeeding due to the potential for serious adverse reactions in breastfed infants.

This drug has been found in rat milk at a milk to plasma ratio of 0.49 which means this drug and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. Although, it is unknown if this drug is excreted into human milk, there is potential for serious harm to the developing kidney if the breastfed infant is exposed. Human kidney maturation occurs during the first 2 years of life. Juvenile rats directly exposed to this drug have shown renal pelvic and tubular dilations during maturation. The long-term functional consequences of these effects are unknown. Additionally,decreased weight gain has been associated with lactational exposure in juvenile rats.