Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders

Abstract

Objective: To provide the fi rst update on drug safety profi les and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database. Methods: We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders. Results: The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2 % ) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1 st trimester (85.4 % ), especially for the fi rst 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8 % ), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck. Conclusions:The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identifi ed drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.

Detection of Medication Errors in Primary Care Units through Passive Voluntary Reporting Forms

“…If the information received from the consumer is incomplete, assessors should try to make direct contact with the consumer or a nominated healthcare provider for more information [16]. The reporting rate of fetal disorders has increased during the last 20 years, from only one report in 1991 to an upper limit of thirty-one reports in 2008 [17]. In the current study, only 7% (8/115) p<0.001 of the reports were pregnancy cases.…”

Adverse drug reactions reported during pregnancy and associated congenital disorders

“…Not all medications can be accused of crossing the placenta and causing direct harm to the baby (teratogenic effect), but there are a few which without crossing the placenta can still be harmful to the fetus by either changing the physiology of the mother (for example causing hypotension), or by narrowing the vessels of placenta resulting in a decrease of nutrient and gas exchange, or by even giving rise to severe uterine hypotonia that ultimately leads to anoxic injury. Also, 85.4 % of the drug admission was noticed during the first trimester of pregnancy, chiefly in the first six weeks of being pregnant when the women are usually unaware of them having conceived (Wettach et al, 2013).…”

“…Many adverse drug reactions (ADRs) have been reported for the frequently consumed drugs during pregnancy which includes fetal malformations (Wettach et al, 2013), neural tube defects (spina bifida, anencephaly) (Khan et al, 2020), chromosomal abnormalities (Wettach et al, 2013), growth retardation (Wettach et al, 2013), congenital heart disease, renal failure, fetal goiter, etc. Some antibacterials consumed during pregnancy can lead to ototoxicity (resulting in fetal deafness), Gray baby syndrome, musculoskeletal defects, hemolysis, jaundice of neonate, etc.…”

Counselling of Pregnant Women at the Pharmacy About Rational Use of Medicinal Substances: Association With Age and Education of Pharmacy Specialists

“…Researchers have found that they do not always inform physicians or midwifes about medicinal substances they are using [7][8]. And the most frightening adverse reaction to the medicinal substance is teratogenicity [9].…”