Purpose: The purpose of this study is to elucidate the characteristics of adverse events in pregnant women, the offending drugs, and patient backgrounds from reports of adverse events. We performed a case series study.
Methods: We used CARPIS, a database of adverse events and toxication reported in Japan spanning from 1987 to 2014 and created by the Drug Information Center, Meijo University. We extracted cases of adverse events in pregnant women, their fetuses, and newborns and investigated the age, primary disease, and history of allergies of the women and the intended use of/offending drugs, therapeutic category, and names for adverse events.
Result: We collected 434 cases of adverse events in pregnant women, and 251 pediatric cases with adverse events. The most frequent offending drug in both groups was ritodrine hydrochloride. The most frequent adverse event in pregnant women was pulmonary oedema due to the administration of ritodrine hydrochloride. The most frequently reported adverse events in pediatric cases were transient hypothyroidism and withdrawal symptoms in newborns and birth abnormalities in fetuses and newborns, all of which were caused by drugs given for the underlying diseases of their mothers.
Discussion: We elucidated serious adverse events in pregnant women caused by the administration of ritodrine hydrochloride. Frequent factors for adverse events were the onset of physiological factors in pregnant women and complicated factors of the mechanism of action of ritodrine hydrochloride. We need to monitor both mothers and fetuses during the drug administration. It is suggested that adverse events in pediatric cases are associated with drugs given for underlying diseases in mothers. Thus, it is necessary to give appropriate information and communicate the risks of taking these drugs before pregnancy. We believe the results could be helpful in the early detection of adverse events in the future.
