Postmarketing analysis of medicines: methodology and value of the spanish case-control study and surveillance system in preventing birth defects.

摘要: There are many surveillance systems of congenital defects all over the world; several them have developed specific approaches to generate and test selected hypotheses regarding human teratogens. However, best our knowledge, none a permanent systematised programme for study risk safety drugs. The aim this article is describe research on potential effects drugs in pregnancy followed by Spanish Collaborative Study Congenital Malformations (ECEMC), which ongoing case-control system. analyse includes continuous systematic medicines used during pregnancy. This has characteristics that make it different from other current systems: (i) collection numerous datapoints (up 312 per infant) design; (ii) use versatile coding birth defects; (iii) analysis each type been specifically ECEMC methodology, including its dysmorphological description ECEMC’s approach drug may help researches area, particularly those using data registries.