What is Simvastatin's pregnancy category?

Simvastatin is classified as contraindicated during pregnancy, particularly in the first trimester, due to concerns over potential teratogenic effects. Statins, including Simvastatin, have been associated with adverse outcomes in fetal development based on animal studies and limited human data. They may interfere with cholesterol synthesis, which is crucial for fetal development, particularly in the early stages of pregnancy.

Meanwhile, categories A, B, and C reflect varying levels of risk based on available data. Category A indicates that controlled studies in pregnant women have not shown any risk, while Category B suggests that animal reproduction studies have failed to demonstrate risk and there are no adequate studies in pregnant women. Category C indicates that animal studies have shown an adverse effect, but there are no well-controlled studies in humans, and the potential benefits may warrant use despite the risks. Since the evidence suggests significant risk associated with Simvastatin, particularly in the first trimester when organogenesis occurs, it is essential that it is avoided in pregnancy, making the classification as contraindicated appropriate.