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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective analysis of patient records from January 2007 to December 2012, seven pregnant women aged 31−45 years were described, who were inadvertently exposed to category X drugs (drugs contraindicated in pregnancy) including medroxyprogesterone, estradiol valerate/norgestrel, ethinylestradiol/desogestrel, caffeine/ergotamine/mecloxamine/paracetamol, atorvastatin or estradiol benzoate/progesterone during first trimester of pregnancy, which resulted in spontaneous abortion (five women) and preterm delivery (two women). Additionally, a male neonate was also described, who was born with congenital cryptorchidism following in-utero exposure to estradiol valerate/norethisterone during first trimester [not all duration of treatments to reactions onsets stated].
Case 1: A...
- Ozturk Z, et al. Birth outcomes after inadvertent use of category x drugs contraindicated in pregnancy: Where is the real risk?. Turkish Journal of Pediatrics 60: 298-305, No. 3, Jan 2018. Available from: URL: http://doi.org/10.24953/turkjped.2018.03.010 - Turkey