FDA, EMA reviews of dolutegravir underway after birth defects

FDA, EMA reviews of dolutegravir underway after birth defects Reactions 1704, p1 - 2 Jun 2018 FDA, EMA reviews of dolutegravir underway after birth defects Reviews are underway in the US and EU into the safety of the HIV medicine dolutegravir following serious cases of neural tube defects, according to the US 1,2 FDA and EMA. In the US, dolutegravir was granted marketing approval in 2013 and it is available as a single ingredient product (Tivicay) as well as a fixed-dose combination tablet with other HIV medicines (dolutegravir/rilpivirine [Juluca]; abacavir/dolutegravir/lamivudine [Triumeq]). The FDA has stated that "preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects". However, the FDA added that there have been no reported cases of babies born with neural tube defects whose mothers initiated dolutegravir later in their pregnancy. The EMA is also evaluating preliminary data from this Botswana study involving >11 500 HIV-infected It was demonstrated that 0.9% of babies women. experienced a neural tube defect whose mothers became pregnant while receiving dolutegravir, versus 0.1% of babies whose mothers took other HIV medicines. Final results from this study are expected in approximately 1 year. In the EU, dolutegravir has been authorised since 2014 (as Tivicay and Triumeq). Juluca has received a positive opinion from the CHMP and is awaiting a decision from the European Commission. In the meantime while the FDA and EMA are conducting their respective reviews, healthcare professionals and/or patients are advised to follow this precautionary advice: Dolutegravir-containing HIV medicines should not be prescribed to women intending to become pregnant. Women who are capable to becoming pregnant should use effective contraception while taking dolutegravir-containing medicines. Before starting dolutegravir therapy, women should take a pregnancy test to determine if they are already pregnant. Women prescribed dolutegravir should not stop taking this medicine without first consulting their doctor. If pregnancy is confirmed in the first trimester while a woman is receiving dolutegravir, their healthcare professional should switch them to an alternative treatment (unless no suitable treatment is available). * CHMP = Committee for Medicinal Products for Human Use 1. US Food and Drug Administration. FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq). Internet Document : 18 May 2018. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm. 2. European Medicines Agency. New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir. Internet Document : 18 May 2018. Available from: URL: http://www.ema.europa.eu/ema/ index.jsp?curl=pages/news_and_events/news/2018/05/ news_detail_002956.jsp&mid=WC0b01ac058004d5c1. 0114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved Reactions 2 Jun 2018 No. 1704 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

FDA, EMA reviews of dolutegravir underway after birth defects

Reactions Weekly , Volume 1704 (1) – Jun 2, 2018
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Publisher
Springer Journals
Copyright
Copyright © 2018 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-018-46644-8
Publisher site
See Article on Publisher Site

Abstract

Reactions 1704, p1 - 2 Jun 2018 FDA, EMA reviews of dolutegravir underway after birth defects Reviews are underway in the US and EU into the safety of the HIV medicine dolutegravir following serious cases of neural tube defects, according to the US 1,2 FDA and EMA. In the US, dolutegravir was granted marketing approval in 2013 and it is available as a single ingredient product (Tivicay) as well as a fixed-dose combination tablet with other HIV medicines (dolutegravir/rilpivirine [Juluca]; abacavir/dolutegravir/lamivudine [Triumeq]). The FDA has stated that "preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects". However, the FDA added that there have been no reported cases of babies born with neural tube defects whose mothers initiated dolutegravir later in their pregnancy. The EMA is also evaluating preliminary data from this Botswana study involving >11 500 HIV-infected It was demonstrated that 0.9% of babies women. experienced a neural tube defect whose mothers became pregnant while receiving dolutegravir, versus 0.1% of babies whose mothers took other HIV medicines. Final results from this study are expected in approximately 1 year. In the EU, dolutegravir has been authorised since 2014 (as Tivicay and Triumeq). Juluca has received a positive opinion from the CHMP and is awaiting a decision from the European Commission. In the meantime while the FDA and EMA are conducting their respective reviews, healthcare professionals and/or patients are advised to follow this precautionary advice: Dolutegravir-containing HIV medicines should not be prescribed to women intending to become pregnant. Women who are capable to becoming pregnant should use effective contraception while taking dolutegravir-containing medicines. Before starting dolutegravir therapy, women should take a pregnancy test to determine if they are already pregnant. Women prescribed dolutegravir should not stop taking this medicine without first consulting their doctor. If pregnancy is confirmed in the first trimester while a woman is receiving dolutegravir, their healthcare professional should switch them to an alternative treatment (unless no suitable treatment is available). * CHMP = Committee for Medicinal Products for Human Use 1. US Food and Drug Administration. FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq). Internet Document : 18 May 2018. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm. 2. European Medicines Agency. New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir. Internet Document : 18 May 2018. Available from: URL: http://www.ema.europa.eu/ema/ index.jsp?curl=pages/news_and_events/news/2018/05/ news_detail_002956.jsp&mid=WC0b01ac058004d5c1. 0114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved Reactions 2 Jun 2018 No. 1704

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Reactions WeeklySpringer Journals

Published: Jun 2, 2018

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