5 Interactions found for:

The following applies to the ingredients: Clopidogrel (found in Plavix)

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Use is not recommended. When possible, discontinue this drug 5 to 7 days prior to labor, delivery, or neuraxial blockade.

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

Risk Summary: Available data from cases reported in published literature and postmarketing surveillance have not identified an association with use of this drug in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes.

While this drug is known to cross the placenta, animal studies have failed to reveal evidence of fetal harm. Reproduction studies performed in rats and rabbits at doses of 500 and 300 mg/kg/day (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis) revealed no evidence of impaired fertility or fetotoxicity. There are no controlled data in human pregnancy.

Use of this drug during labor or delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade during use of this drug.

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: Rosuvastatin (found in Crestor)

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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: Clopidogrel (found in Plavix)

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This drug has been used without apparent harmful effects. However, use is not recommended or contraindicated per some authorities. Benefit should outweigh risk in case of use during lactation.

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

Comments: The effects in the nursing infant are unknown.

The following applies to the ingredients: Rosuvastatin (found in Crestor)

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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.