OBJECTIVE: Phloroglucinol is used to prevent gastric, intestine or urogenital spasms. In France, many pregnant women are exposed to phloroglucinol for which no data are available about its use in pregnancy. The present study, using EFEMERIS database, investigates potential teratogenic risk of phloroglucinol in pregnancy. MATERIALS AND METHODS: EFEMERIS is a database including prescribed and delivered drugs during pregnancy (data from Caisse Primaire d'Assurance Maladie of Haute-Garonne) and outcomes (data from Maternal and Infant Protection Service and from Antenatal diagnostic Centre). Women delivered from July 1st 2004 to June 30th 2008 in Haute-Garonne and registered in the French Health Insurance Service were included into EFEMERIS database. We compared pregnancy outcomes and newborn health between women exposed to phloroglucinol during organogenesis and non-exposed women. Malformations were classified according to Eurocat classification. RESULTS: Five thousand one hundred and thirty-two newborns (12.7%) exposed during organogenesis to phloroglucinol were compared to 35,223 controls (non exposed newborns). The mean number of different drugs prescribed during the first trimester of pregnancy per woman was higher in women exposed to phloroglucinol than in non-exposed women (6.4 ± 4.3 versus 2.4 ± 3.3, P < 10(-4)). Among newborns, 126 (2.5%) had a malformation versus 804 (2.3%) in control newborns (OR=1.1, [0.9-1.3]). The present study was powered to find a 1.3 fold increase in the overall rate of major anomalies. DISCUSSION AND CONCLUSION: This first epidemiologic study about phloroglucinol in pregnancy does not support evidence of a teratogenic risk for phloroglucinol in humans.
OBJECTIVE:Phloroglucinol is used to prevent gastric, intestine or urogenital spasms. In France, many pregnant women are exposed to phloroglucinol for which no data are available about its use in pregnancy. The present study, using EFEMERIS database, investigates potential teratogenic risk of phloroglucinol in pregnancy. MATERIALS AND METHODS: EFEMERIS is a database including prescribed and delivered drugs during pregnancy (data from Caisse Primaire d'Assurance Maladie of Haute-Garonne) and outcomes (data from Maternal and Infant Protection Service and from Antenatal diagnostic Centre). Women delivered from July 1st 2004 to June 30th 2008 in Haute-Garonne and registered in the French Health Insurance Service were included into EFEMERIS database. We compared pregnancy outcomes and newborn health between women exposed to phloroglucinol during organogenesis and non-exposed women. Malformations were classified according to Eurocat classification. RESULTS: Five thousand one hundred and thirty-two newborns (12.7%) exposed during organogenesis to phloroglucinol were compared to 35,223 controls (non exposed newborns). The mean number of different drugs prescribed during the first trimester of pregnancy per woman was higher in women exposed to phloroglucinol than in non-exposed women (6.4 ± 4.3 versus 2.4 ± 3.3, P < 10(-4)). Among newborns, 126 (2.5%) had a malformation versus 804 (2.3%) in control newborns (OR=1.1, [0.9-1.3]). The present study was powered to find a 1.3 fold increase in the overall rate of major anomalies. DISCUSSION AND CONCLUSION: This first epidemiologic study about phloroglucinol in pregnancy does not support evidence of a teratogenic risk for phloroglucinol in humans.
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