Congenital bladder exstrophy associated with Duogynon hormonal pregnancy tests—Signal for teratogenicity or consumer report bias?

Highlights: [•] We evaluated a database on patients with birth defects prenatally exposed to Duogynon. [•] Birth defects were compared to data from a population based birth register. [•] Proportional reporting ratio revealed an OR of 37 for bladder exstrophy among exposed. [•] A reporting bias of consumer ADR reports may explain our finding. [•] The present study highlights the difficulties of evaluating consumer reports which may be influenced by public media. [ABSTRACT FROM AUTHOR]