Juvisync Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: X
Women of childbearing potential should be advised to use effective contraception during treatment with simvastatin-sitagliptin. The patient should be informed of potential hazard to the fetus if she becomes pregnant while taking this drug. This drug should be immediately discontinued if pregnancy occurs.
There are no adequate and well-controlled studies of use this drug during pregnancy; however, in rare reports congenital anomalies were observed following intrauterine exposure to statins.
Simvastatin: While animal studies failed to reveal evidence of teratogenicity, animal studies with other HMG-CoA reductase inhibitors revealed an increase in the incidence of skeletal malformations. There are no controlled data in human pregnancy. However, HMG-CoA reductase inhibitors are known to inhibit biosynthetic processes necessary in fetal development. Lipid lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy.
Sitagliptin: Animal studies revealed that doses of sitagliptin approximately 12 times the human exposure, at the maximum recommended human dose, did not impair fertility or harm the fetus; however, there are no adequate and well controlled studies in pregnant women. In addition, higher doses of this drug in pregnant rats increased the incidence of rib malformations in offspring.
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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
See references
