This is called her background risk. (PDF/126.71 KB) The Rapporteur and Co-Rapporteur appointed were: Dr P Neels and Dr T Salmonson, respectively. Background: Women in their childbearing years often require drug therapy for allergic conditions.
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A study of 161 women taking loratadine during the first trimester did not show any differences in the rates of miscarriage. (PDF/119.02 KB) (PDF/112.97 KB) All patients were exposed at least during the first trimester (13 weeks) of pregnancy. (PDF/120.74 KB)
It is unlikely that loratadine would cause an increased chance for …
Maternal characteristics (age, pregnancy history, alcohol consumption, and smoking habits) were not different between the 2 groups.
Methods: All women were prospectively enrolled from 4 participating centers. (PDF/120.74 KB) In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. (PDF/118.58 KB)
Among the loratadine exposed cohort there were 140 live births, 18 spontaneous abortions, 3 elective abortions, and 1 fetal death. (PDF/123.27 KB) (PDF/399.32 KB) A group of unexposed control subjects were recruited and followed up in a similar manner. (PDF/112.97 KB) (PDF/123.27 KB) Data included 1 set of twins in each group. ScienceDirect ® is a registered trademark of Elsevier B.V.Fetal safety of loratadine use in the first trimester of pregnancy: A multicenter studyScienceDirect ® is a registered trademark of Elsevier B.V. By continuing you agree to the Copyright © 2020 Elsevier B.V. or its licensors or contributors. Loratadine (Claritin) ... , Koren G. Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a … (PDF/401.16 KB) Among 2,780 exposed pregnancies there were in total 15 cases of hypospadia vs. the expected incidence of 6-7 cases. (PDF/118.58 KB) (PDF/123.27 KB) (PDF/115.52 KB) The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State.
(PDF/126.59 KB) (PDF/115.52 KB) The database consisted of 1,020 infants born to women who reported use of loratadine before the first antenatal visit.During 1999, this signal was evaluated by the MPA, the SMBR and the MAH of the product in Sweden, Schering Plough, both by review of the clinical cases, and from a preclinical point of view. (PDF/120.74 KB) To date no published data exist on the safety of loratadine use in pregnancy. (PDF/126.59 KB) The adjusted OR for exposure to loratadine in the first trimester and 30 days before conception was 1.1 (95% CI: 0.0-7.7), and the OR for exposure to other antihistamines in the same period was 1.7 (95% CI: 0.5-4.7). Can taking loratadine during pregnancy cause birth defects? The adjusted OR for exposure to loratadine within the first six months of pregnancy was 0.6 (95% CI 0.0-3.8) and for the entire pregnancy 0.5 (95% CI 0.0-2.7). The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III.The final opinion was converted into a Decision by the European Commission on 28 April 2004.
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(PDF/384.76 KB) The authors calculate that in order to rule out a doubling of the risk, they would need a … (PDF/152.39 KB)
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