Why the study?
Discontinuation of sustained-release nifedipine led to off-label use of amlodipine in pregnancy despite lower levels of evidence, prompting the need to address concerns based on scientific evidence.
Is amlodipine safe and effective for the management of hypertensive disorders of pregnancy?
Is amlodipine safe and effective for the management of hypertensive disorders of pregnancy?
This position statement provides guidance on the off-label use of amlodipine for hypertensive disorders of pregnancy following the discontinuation of sustained-release nifedipine.
Pharmacological management of HDP includes agents supported by extensive evidence ensuring their safety for use. Among those traditionally described in the literature are: alpha-methyldopa, labetalol, and sustained-release nifedipine (NIF-RETARD). These drugs, in addition to being compatible with pregnancy, present additional eligibility criteria. The discontinuation of NIF-RETARD has resulted in the off-label use of other dihydropyridine calcium cannel blockers with lower levels of evidence in pregnancy, such as amlodipine. The Working Group Hypertension in Women of the Argentine Society of Hypertension has proposed to develop a document that precisely and thoroughly addresses the concerns related to the use of amlodipine in pregnancy, providing responses based on the currently available scientific evidence.
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Ghelfi et al. (2024) studied this question.
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