Safety of domperidone use in clinical practice
S.M. Kirov Military Medical Academy, St. Petersburg
S.M. Kirov Military Medical Academy, St. Petersburg
Domperidone for a long period is used to treat symptoms of gastroparesis, nausea and vomiting. However, despite high clinical efficacy, a number of patients receiving domperidone in the world began to decline due to publications about an expressed cardiac risk. Analysis of the reasons for the restriction of the drug use made it possible to establish a fact of using domperidone in high doses (80–120 mg) exceeding a recommended dosage over a long period in patients without considering a risk of arrhythmias. In some cases, domperidone has been used by lactating women to improve breast milk production, which has led to negative effects in children, since no children were examined and the drug was used in high doses (sometimes a parenteral form). At the same time, significant experience has accumulated of safe domperidone use in both adults and children, when following instructions for the drug use. A standard examination for patients with cardiovascular diseases (ECG, determination of potassium, calcium and magnesium levels), an exclusion of macrolide antibiotic and antifungal agent use, that increases domperidone concentration in the blood, and a prescription of recommended dosages of the drug let us not only avoid negative effects, but also increase effectiveness of the therapy.
Key words: domperidone, safety, cardiac risk.
For citation: Grinevich V.B., Sas E.I. Safety of domperidone use in clinical practice // RMJ. Medical Review. 2018.
№ 7(I). P. 37–40.
References
1. ReynoldsJ.C., PutnamP.E.Prokinetic agents // Gastroenterol. Clin. North. Am. 1992. Vol. 21. P. 567–596.
2. BaroneJ.A.Domperidone: A Peripherally Acting Dopamine2–Receptor Antagonist // Ann. Pharmacother. 1999. Vol. 33. P. 429–440.
3. ParkmanH.P., JacobsM.R., MishraA. et al. Domperidone Treatment for Gastroparesis: Demographic and Pharmacogenetic Characterization of Clinical Efficacy and Side-Effects Digestive Diseases and Sciences // Dig. Dis. Sci. 2011. Vol. 56 (1). P. 115–124.
4. PritchardD.S., BaberN., StephensonT.Should domperidone be used for the treatment of gastrooesophageal reflux in children? Systematic review of randomized controlled trials in children aged 1 month to 11 years old // Br. J.Clin. Pharmacol. 2005. Vol. 59 (6). P. 725–729.
5. AbrahamssonH.Gastrointestinal motility disorders in patients with diabetes mellitus // J Intern Med. 1995. Vol. 23. P. 403–439.
6. PattersonD., AbellT., RothsteinR. et al. A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis // Am. J.Gastroenterol. 1999. Vol. 94 (5). P. 1230–1234.
7. SugumarA., SinghA., PasrichaP.J. A systematic review of the efficacy of domperidone for the treatment of diabetic gastroparesis // Review published. 2008. Vol. 6 (7). P. 726–733.
8. OrtizA., CooperC.J., AlvarezA. et al. Cardiovascular Safety Profile and Clinical Experience With High-Dose Domperidone Therapy for Nausea and Vomiting // Am. J.Med. Sci. 2015. Vol. 349 (5). P. 421–424.
9. ScheyR., SaadiM., MidaniD. et al. Domperidone to Treat Symptoms of Gastroparesis: Benefits and Side Effects from a Large Single-Center Cohort // Dig. Dis. Sci. 2016. Vol. 61(12). P. 3545–3551.
10. Domperidone IND Packet [Электронный ресурс] // US Food and Drug Administration. 2018. 17 p. URL: https://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm520728.pdf (дата обращения: 10.08.2018).
11. Bioanalytical Method Validation. Guidance for Industry [Электронный ресурс] // US Food and Drug Administration. 2018. 41p. URL: http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf (дата обращения: 10.08.2018).
12. ViswanathanC.T., BansalS., BoothB. et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays // Pharm. Res. 2007. Vol. 24 (10). P. 1962–1973.
13. GulemezA., BabaoglA., ArisoyA.E. et al. Effect of domperidone on the QTc interval in premature infants // Journal of Perinatology. 2010. Vol. 30. P. 50–53.
14. АрхиповВ.В., СереброваС.Ю.Безопасность применения прокинетиков в практике терапевта на примере домперидона (Мотилака) // РМЖ. 2007. №16. С. 1218–1220 [Arhipov V.V., SerebrovaS.Ju. Bezopasnost’ primenenija prokinetikov v praktike terapevta na primere domperidona (Motilaka) // RMZh. 2007. №16. S. 1218–1220 (in Russian)].
15. IoannouA., JainA., KassianosG., MissourisC.Survey of the use of domperidone and the association with QTc prolongation in general practice // Postgrad Med. J. 2016. Vol. 92. P. 390–392.
This work is licensed under a Creative Commons «Attribution» 4.0 License.
Previous article
Next article
Распечатать