The Potential Teratogenicity Alert for Women Conceiving on Dolutegravir-Based Regimens: An Assessment of Risk Communication by an Urban HIV Clinic in Uganda and Choices made by Women

Introduction and Objective In May 2018, the World Health Organization and other regulatory authorities released a safety alert for dolutegravir related to a risk of neural tube defects among women exposed to dolutegravir at the time of conception. Models of how drug safety information can be shared...

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Bibliographic Details
Published in:Drug safety 2020-11, Vol.43 (11), p.1133-1140
Main Authors: Laker, Eva Agnes Odongpiny, Arinaitwe, Arnold, Owarwo, Noela, Onzia, Annet, Nasasira, Benson, Wailagala, Abdullah, Kalule, Ivan, Anguzu, Godwin, Kiragga, Agnes, Seden, Kay, Lwanga, Isaac, Castelnuovo, Barbara, Musomba, Rachel, Lamorde, Mohammed
Format: Article
Language:English
Subjects:
Accuracy
Antiretroviral drugs
Birth control
Communication
Condoms
Contraception
Contraceptives
Drug Safety and Pharmacovigilance
Drugs
Efavirenz
Family planning
Health risks
HIV
Human immunodeficiency virus
Infectious diseases
Medicine
Medicine & Public Health
Menopause
Neural tube defects
Original Research Article
Pharmacology/Toxicology
Pharmacovigilance
Pituitary (anterior)
Pregnancy
Public health
Regression analysis
Regulatory agencies
Risk assessment
Risk communication
Safety
Switching
Teratogenicity
Tropical diseases
Ultrasound
Womens health
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Summary:Introduction and Objective In May 2018, the World Health Organization and other regulatory authorities released a safety alert for dolutegravir related to a risk of neural tube defects among women exposed to dolutegravir at the time of conception. Models of how drug safety information can be shared effectively in the shortest time are necessary to prevent interruptions of public health programs. We sought to describe an implementation process to inform and support women already on dolutegravir-based regimens at the time of conception to make informed choices following the safety alert of a potential teratogenicity risk. We describe the choices made by women, as well as determine the factors associated with women’s choices to switch off dolutegravir. Methods A clinic response plan was developed in the first week following the alert and clinic staff were trained on safety guidance. All women aged 
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-020-00974-9