Retracted: The safety of ritodrine hydrochloride: Adverse effects on fetuses and newborns

Abstract

Ritodrine hydrochloride, pregnant women, fetuses, newborns, adverse effects Prematurely born infants face unique risks, and the treatment of imminent preterm birth is thus an important part of perinatal care. Ritodrine hydrochloride (Rito) is widely used as a therapeutic agent to treat imminent preterm birth in Japan. Following assessment of the risks and benefits of shortacting β-agonists, including Rito, in Europe, however, the use of Rito has begun to be questioned. Thus, in this study we investigated the safety of Rito in the treatment of imminent preterm birth, with a particular focus on the adverse effects (AEs) on fetuses and newborn infants. Using the Pharmaceuticals and Medical Devices Agency of Japan's Japanese Adverse Drug Event Report (JADER) database, the AEs on fetuses and newborns caused by oral and injected Rito were extracted and analyzed. The reported odds ratios for oral Rito were significantly higher for fetal tachycardia, fetal bradycardia, neonatal hypoglycemia, and neonatal heart failure than for other drugs. The reported odds ratios for Rito injection were significantly higher for fetal tachycardia and neonatal hypoglycemia than for other drugs. Oral drugs had more adverse effect reports than injectable drugs.

Relationship between maternal mortality and ritodrine hydrochloride as a tocolytic agent in Japan

“…Serious maternal adverse reactions such as pulmonary edema, myocardial ischemia, ketoacidosis, metabolic abnormalities, and leukopenia have been reported, 17–19 while fetal tachycardia or/and bradycardia, neonatal hypoglycemia, and neonatal heart failure were adverse reactions in neonates, following both oral and injected treatment, and caution has been advised when administering ritodrine to the mother. Patients are alerted to these potential adverse reactions when ritodrine is administered 20–22 . The results of the present study were generally in line with those of previous studies.…”

“…Patients are alerted to these potential adverse reactions when ritodrine is administered. [20][21][22] The results of the present study were generally in line with those of previous studies. As no reports of cerebral hemorrhage have been published, this finding might be new.…”