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Safety of medicines and vaccines in pregnancy under the spotlight at UCT workshop

25 Oct 2017 - 09:30

“Building capacity for the protection of pregnant women and their infants”


Dr Christine Halleux (WHO), Ms Ottencia Mhlongo (KwaZulu Natal Provincial Department of Health), Prof Lavinia Schuler-Faccini (Federal University of Rio Grande do Sul), Dr Ushma Mehta (CIDER)

The University of Cape Town’s Centre for Infectious Diseases Epidemiology and Research (CIDER) recently hosted an innovative workshop aimed at building capacity in Africa for the surveillance of poor birth outcomes by developing the science of teratovigilance. This involves assessing how infections, chronic diseases, medicines and other exposures during pregnancy may be causally linked to outcomes such as stillbirth, prematurity, neonatal death and congenital disorders.

The growing appreciation of the need to collect information on the safety of medicines and vaccines in pregnancy prompted the creation of an international pregnancy exposure registry database by the World Health Organisation and various initiatives aimed at building pharmacovigilance capacity in Africa, and South Africa in particular.

Professor Landon Myer, Head of School of Public Health and Family Medicine at UCT, says: “Ultimately, pregnant women should be confident about the safety of the medicines they use particularly for common potentially devastating conditions such as HIV, TB, hypertension, and malaria. Developing our ability to assess how exposures in pregnancy affect maternal and neonatal health is integral to achieving this.”

Maternal and neonatal teratovigilance in the African context requires innovation of research and surveillance approaches based on sound clinical and epidemiological principles.

At the workshop, international and local experts shared their knowledge and experiences in developing surveillance systems and regulatory mechanisms aimed at protecting pregnant women and their children. Clinicians, regulators, and scientists from Botswana, Cameroon, Malawi, Mozambique, Nigeria, South Africa, Zambia and Zimbabwe came together to share data, expertise and experience across sites and countries to build the critical capacity needed.

Specific focus was given on exposures such as alcohol, antimalarials, anti-epileptics and antiretrovirals. There was consensus on the importance and urgency of this work given the information vacuum in Africa where even prevalence rates of congenital disorders are unknown. The meeting represented a unique opportunity for collaboration across the region and a multi-disciplinary approach to teratovigilance research acknowledging the correlation with improvements in clinical care of pregnant women and infants. Dr Helen Malherbe from the University of KwaZulu Natal concludes: “[…] the meeting really highlighted the overlap between communicable and non-communicable diseases – and not just by the potential teratogenic effects of drugs used during pregnancy, but due to the potential to integrate services in the ongoing continuum of care for all these conditions in an effort to improve the quality of care and life for the patient. There are also many parallels between HIV and birth defects that are worthy of further exploration.”


Prof Lewis B. Holmes, Unit of Medical Genetics & Perinatal Diagnostic Unit, Obstetrics Programme, MassGeneral Hospital for Children, Boston

Issued by: UCT Communication and Marketing Department