PMID- 33642492 OWN - NLM STAT- MEDLINE DCOM- 20210917 LR - 20210917 IS - 1881-784X (Electronic) IS - 1881-7831 (Linking) VI - 15 IP - 1 DP - 2021 Mar 10 TI - The safety of ritodrine hydrochloride: Adverse effects on fetuses and newborns. PG - 14-19 LID - 10.5582/ddt.2021.01016 [doi] AB - 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 short-acting beta-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. FAU - Yonaga, Yuriko AU - Yonaga Y AD - Department of Pharmaceutical Sciences, Teikyo Heisei University, Nakano, Tokyo, Japan. FAU - Ito, Akihiko AU - Ito A AD - Department of Pharmaceutical Sciences, Teikyo Heisei University, Nakano, Tokyo, Japan. LA - eng PT - Journal Article PT - Retracted Publication DEP - 20210227 PL - Japan TA - Drug Discov Ther JT - Drug discoveries & therapeutics JID - 101493809 RN - 0 (Tocolytic Agents) RN - I0Q6O6740J (Ritodrine) SB - IM RIN - Drug Discov Ther. 2021;15(2):E1. PMID: 34011822 MH - Administration, Oral MH - Adolescent MH - Adult MH - Adverse Drug Reaction Reporting Systems MH - Drug-Related Side Effects and Adverse Reactions/*etiology MH - Female MH - Humans MH - Infant, Newborn MH - Injections, Intramuscular MH - Japan MH - Pregnancy MH - Premature Birth/*prevention & control MH - Ritodrine/*administration & dosage/adverse effects MH - Tocolytic Agents/*administration & dosage/adverse effects MH - Young Adult OTO - NOTNLM OT - Ritodrine hydrochloride OT - adverse effects OT - fetuses OT - newborns OT - pregnant women EDAT- 2021/03/02 06:00 MHDA- 2021/03/02 06:01 CRDT- 2021/03/01 05:33 PHST- 2021/03/02 06:00 [pubmed] PHST- 2021/03/02 06:01 [medline] PHST- 2021/03/01 05:33 [entrez] AID - 10.5582/ddt.2021.01016 [doi] PST - ppublish SO - Drug Discov Ther. 2021 Mar 10;15(1):14-19. doi: 10.5582/ddt.2021.01016. Epub 2021 Feb 27.