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Hyperprolactinemia after taking Levosulpiride and its Causality Assessment: An Adverse Event Reported by a Community Pharmacy

Levosulpiride 복용 이후 발생한 고프로락틴혈증 및 그 인과성 분석: 지역약국에서 보고된 부작용 증례

  • Received : 2018.04.18
  • Accepted : 2018.05.26
  • Published : 2018.06.29

Abstract

Levosulpiride is one of the most frequently prescribed medicines in Korea. An adverse drug reaction (ADR) after taking levosulpiride was reported at a community pharmacy in Korea. A 31-year-old woman reported the symptoms of lactation and amenorrhea after taking levosulpiride; an evaluation of whether these symptoms were caused by the medication was therefore necessary. Several tools can be used to determine if the ADR resulted from the administered drug or other factors, including the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, the Naranjo scale, and the Korean causality assessment algorithm (Ver. 2). The causality was evaluated as "possible" by the WHO-UMC and Naranjo scales, but as "probable" by the Korean causality assessment algorithm (Ver. 2). In conclusion, the information provided did not indicate definite causality and there were slight differences in the results obtained from each assessment method.

Keywords

References

  1. Kuchay MS, Mithal A. Levosulpiride and Serum Prolactin Levels. Indian J End Metab 2017;21:355-8. https://doi.org/10.4103/ijem.IJEM_555_16
  2. Ministry of Food and Drug Safety (MFDS). Levosulpiride Label. Available from http://drug.mfds.go.kr/html/bxsSearchDrugProduct.jsp?item_Seq=200000519. Accessed December 10, 2017.
  3. Food and Drug Administration (FDA). FDA Approved Drug Products. Available from https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed December 10, 2017.
  4. European Medicines Agency (EMA) Medicine Label. Available from http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landing_page.jsp&mid=. Accessed December 10, 2017.
  5. Hankyoreh. The mean number of prescribing medicines is four which is doulble of the U.S.; caused by unrestricted prescribing for antipeptic agents. Available from http://www.hani.co.kr/arti/society/health/246809.html. Accessed February 10, 2018.
  6. Korean Pharmaceutical Association. Press Releases. Available from http://kpanet.or.kr/. Accessed April 10, 2018.
  7. Rehan HS, Chopra D, Kakkar AK. Causality assessment of spontaneously reported adverse drug events: Comparison of WHO-UMC criteria and Naranjo probability scale. Int J Risk Saf Med 2007;19(4):223-7.
  8. Belhekar MN., Taur SR, Munshi RP. A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions. Indian J Pharmacol 2017;46:117-20.
  9. Majumdar A, Mangal NS. Hyperprolactinemia. J Hum Reprod Sci 2013;6:168-75. https://doi.org/10.4103/0974-1208.121400
  10. Korea Institute of Drug Safety & Risk Mangement. Korean Pharmaceutical Association. News Letter for Regional Pharmacovigillance Center 2017.
  11. Kyung EJ, Ryu JH, Kim EY. Evaluation of adverse reactions to contrast media in the hospital. Briti J Radiol 2013;86:20130418.