Suspected Spontaneous Reports of Birth Defects in the UK Associated with the Use of Carbimazole and Propylthiouracil in Pregnancy

Table 1

Suspected adverse drug reactions of congenital anomalies associated with carbimazole and propylthiouracil received via the UK Yellow Card Scheme.

		Carbimazole			Propylthiouracil
System	Congenital anomalies*	Number of anomalies (total)	Number with single anomaly	Number with other anomalies	Number of anomalies (total)	Number with single anomaly	Number; with other; anomalies
Skin	Aplasia cutis	6	2	4	0	0	0
	Other (skin disorder, ulcer)	2	0	2	0	0	0
Respiratory	Choanal atresia	5	2	3	0	0	0
	Tracheo-oesophageal fistula	2	2	0	0	0	0
	Other (neonatal respiratory distress syndrome, respiratory disorder)	2	0	2	0	0	0
Gastrointestinal	Cleft palate	5	3	2	1	1	0
	Omphalocele/umbilical abnormalities	4	2	2	2	0	2
	Patent vitellointestinal duct	1	0	1	0	0	0
	Duodenal atresia	1	1	0	0	0	0
	Anal atresia	1	0	1	0	0	0
	Other (neonatal jaundice and abnormal liver function tests)	2	0	2	0	0	0
	Not specified	3	2	1	0	0	0
Cardiovascular	Septal defects	3	1	2	0	0	0
	Other (Fallot’s tetralogy and coarctation of aorta)	2	2	0	0	0	0
	Not specified	1	0	1	0	0	0
Musculoskeletal	Limb/hand/foot malformation	4	1	3	3	1	2
	Not specified	4	3	1	0	0	0
Neurological	Spina bifida	3	1	2	0	0	0
	Hydrocephalus	5	1	4	0	0	0
	Anencephaly	4	4	0	1	0	1
	Hypotonia	2	0	2	0	0	0
	Other (spine malformation and holoprosencephaly)	1	0	1	1	0	1
Renal/urinary tract	Renal aplasia	1	0	1	0	0	0
	Other (urinary tract malformation, epispadias)	1	0	1	1	1	0
Endocrine	Thyroid disorder	1	0	1	0	0	0
	Hypogonadism	1	0	1	0	0	0
Craniofacial	Dysmorphic facies	2	0	2	1	0	1
	Skull malformation	4	1	3	0	0	0
	Ear malformation	3	1	2	0	0	0
	Deafness	4	2	2	0	0	0
	Eye malformation	4	1	3	0	0	0
	Other (nose malformation and teeth malformation)	2	0	2	0	0	0
Others	Nipple/breast anomalies (athelia and hypoplastic nipples)	2	0	2	0	0	0
	Developmental delay	2	0	2	0	0	0
	Autism	0	0	0	1	0	1
	Not specified	7	1	6	0	0	0
Total		97	33	64	11	3	8

*One Yellow Card report may contain more than one reaction term. Therefore, the total number of reactions is greater than the total number of reports.