Amlodipine pregnancy category
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Amlodipine Pregnancy Category: Safety and Risks
Introduction to Amlodipine and Pregnancy
Amlodipine is a calcium channel blocker commonly used to treat hypertension. Its use during pregnancy, particularly in the first trimester, raises concerns about potential teratogenic effects and safety for both the mother and the fetus. This article synthesizes current research on the safety and risks associated with amlodipine use during pregnancy.
Teratogenic Risks of Amlodipine in Early Pregnancy
Studies on Morphologic Abnormalities
Research involving 231 women with chronic hypertension, including those treated with amlodipine during early pregnancy, found no significant increase in morphologic abnormalities in their offspring compared to those treated with other antihypertensives or no antihypertensives at all. Specifically, the odds of birth defects in neonates exposed to amlodipine were not significantly different from those in other groups .
Case Reports and Database Analyses
Case reports and database analyses further support the notion that amlodipine is not teratogenic. For instance, a study involving three hypertensive women exposed to amlodipine in the first trimester reported no teratogenic effects, although one case involved a miscarriage that was not attributed to amlodipine . Additionally, a large database analysis from Japan found no significant association between first-trimester exposure to amlodipine and major congenital malformations .
Animal Studies
Contrary to human studies, an animal study on pregnant rats treated with different doses of amlodipine reported the occurrence of teratomas in one of the treated groups, suggesting potential risks at higher doses . However, these findings are not directly translatable to human pregnancies.
Efficacy and Safety of Amlodipine During Pregnancy
Clinical Trials and Pilot Studies
A pilot clinical trial comparing the efficacy and safety of amlodipine, furosemide, and aspirin in pregnant women with mild to moderate chronic hypertension found no significant differences in maternal complications, pre-term births, or neonatal outcomes among the treatment groups . This suggests that amlodipine is as safe and effective as other antihypertensives during pregnancy.
Pharmacokinetics and Breastfeeding
Pharmacokinetic studies indicate that amlodipine crosses the placenta but is not detected in breast milk or infant plasma at significant levels, suggesting it is likely safe for use during the peripartum period and breastfeeding .
Amlodipine and Polycystic Ovarian Syndrome (PCOS)
Effects on Ovulation and Conception
Amlodipine has been studied for its potential benefits in women with PCOS. Research indicates that amlodipine can improve pre-ovulatory follicular blood flow, enhance follicular maturation, and increase the chances of conception when used alongside clomiphene citrate 47. This highlights an additional therapeutic benefit of amlodipine beyond its antihypertensive effects.
Conclusion
Current research suggests that amlodipine is not associated with significant teratogenic risks when used during early pregnancy. It appears to be as safe and effective as other antihypertensives for managing chronic hypertension in pregnant women. Additionally, its use may offer benefits for women with PCOS by improving ovulatory outcomes. However, further large-scale clinical trials are necessary to confirm these findings and ensure the comprehensive safety of amlodipine during pregnancy.
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