Abstract | PURPOSE:
Ivabradine has been approved for the treatment of chronic heart failure and chronic stable angina pectoris in Europe. Based on adverse outcomes of reproductive animal studies and the lack of human data, ivabradine is considered contraindicated during pregnancy. The aim of this observational study is to analyse ivabradine use before and during pregnancy. METHODS: We evaluated all ivabradine-related requests to the German Embryotox Institute from 2007 to 2019. Exposed pregnancies were analysed as to their outcome. RESULTS: CONCLUSION: This case series represents the largest cohort of ivabradine-exposed pregnancies, published so far. According to our findings, ivabradine appears not to be a major teratogen. However, established drugs of choice with strong evidence of low risk for the unborn should be preferred in women planning pregnancy. After inadvertent exposure during pregnancy or lack of treatment alternatives, fetal ultrasound for structural anomalies and growth restriction is recommended. In addition, close monitoring is necessary in pregnant women with supraventricular arrhythmias or cardiac disease.
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Authors | Maria Hoeltzenbein, Marie-Louise Lehmann, Evelin Beck, Katarina Dathe, Christof Schaefer |
Journal | European journal of clinical pharmacology
(Eur J Clin Pharmacol)
Vol. 77
Issue 7
Pg. 1029-1037
(Jul 2021)
ISSN: 1432-1041 [Electronic] Germany |
PMID | 33501507
(Publication Type: Journal Article, Observational Study)
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Chemical References |
- Cardiovascular Agents
- Ivabradine
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Topics |
- Abortion, Spontaneous
(epidemiology)
- Adult
- Cardiovascular Agents
(adverse effects, therapeutic use)
- Congenital Abnormalities
(epidemiology)
- Female
- Humans
- Ivabradine
(adverse effects, therapeutic use)
- Pregnancy
- Pregnancy Outcome
(epidemiology)
- Retrospective Studies
- Tachycardia, Supraventricular
(drug therapy)
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