BACKGROUND: The intake of medicines during pregnancy can have negative or toxic effects on the fetus, possibly leading to adverse pregnancy outcomes. OBJECTIVE: The aim of this study was to describe the level of drug exposure during pregnancy in a rural area of Mozambique and its relation to pregnancy outcome. METHODS: A total of 3105 pregnant women were interviewed in a cohort study. Information on disease, treatments received during pregnancy, and pregnancy outcome was collected. Newborns were examined at birth for clinical signs, birthweight, and presence of any congenital malformation. RESULTS: Malaria and sexually transmitted diseases were the most frequently reported diseases (30.5% and 24.1%, respectively), and 41% (1276/3105) of participants reported at least one drug exposure. The mean number of drugs taken per pregnant woman was 3.9 (SD 2.1). Antibiotics were the most commonly (41.2%) reported agents, followed by antimalarials (23.8%). There were more stillbirths (p < 0.007) among those reporting to be exposed to drugs compared with no exposure. Polydactyly was the most frequent malformation observed. CONCLUSIONS: Drug exposure during pregnancy, including drugs with recognized potential pregnancy risk, was high in this rural area of southern Africa. The association of stillbirths with drug exposure might be a consequence of the disease that led to drug administration, although a direct causality of the drugs cannot be excluded. These findings emphasize the need for reinforcing pharmacovigilance systems in rural Africa, especially, or at least, in pregnant women.
BACKGROUND: The intake of medicines during pregnancy can have negative or toxic effects on the fetus, possibly leading to adverse pregnancy outcomes. OBJECTIVE: The aim of this study was to describe the level of drug exposure during pregnancy in a rural area of Mozambique and its relation to pregnancy outcome. METHODS: A total of 3105 pregnant women were interviewed in a cohort study. Information on disease, treatments received during pregnancy, and pregnancy outcome was collected. Newborns were examined at birth for clinical signs, birthweight, and presence of any congenital malformation. RESULTS:Malaria and sexually transmitted diseases were the most frequently reported diseases (30.5% and 24.1%, respectively), and 41% (1276/3105) of participants reported at least one drug exposure. The mean number of drugs taken per pregnant woman was 3.9 (SD 2.1). Antibiotics were the most commonly (41.2%) reported agents, followed by antimalarials (23.8%). There were more stillbirths (p < 0.007) among those reporting to be exposed to drugs compared with no exposure. Polydactyly was the most frequent malformation observed. CONCLUSIONS: Drug exposure during pregnancy, including drugs with recognized potential pregnancy risk, was high in this rural area of southern Africa. The association of stillbirths with drug exposure might be a consequence of the disease that led to drug administration, although a direct causality of the drugs cannot be excluded. These findings emphasize the need for reinforcing pharmacovigilance systems in rural Africa, especially, or at least, in pregnant women.
Authors: Tubao Yang; Mark C Walker; Daniel Krewski; Qiuying Yang; Carl Nimrod; Peter Garner; William Fraser; Olufemi Olatunbosun; Shi Wu Wen Journal: Pharmacoepidemiol Drug Saf Date: 2008-03 Impact factor: 2.890
Authors: Ariel Q Nhacolo; Delino A Nhalungo; Charfudin N Sacoor; John J Aponte; Ricardo Thompson; Pedro Alonso Journal: BMC Public Health Date: 2006-11-30 Impact factor: 3.295
Authors: Toussaint Rouamba; Innocent Valea; Joel D Bognini; Herve Kpoda; Petra F Mens; Melba F Gomes; Halidou Tinto; Fati Kirakoya-Samadoulougou Journal: Drugs Real World Outcomes Date: 2018-09
Authors: Ushma Mehta; Christine Clerk; Elizabeth Allen; Mackensie Yore; Esperança Sevene; Jan Singlovic; Max Petzold; Viviana Mangiaterra; Elizabeth Elefant; Frank M Sullivan; Lewis B Holmes; Melba Gomes Journal: BMC Pregnancy Childbirth Date: 2012-09-03 Impact factor: 3.007