Domperidone a Retrospective Review of Tolerability and Safety Profile (P2.345)

Objective: Preliminary data was collected to explore potential safety and efficacy of oral domperidone in movement disorder patients. Background: Domperidone is widely used for nausea and vomiting, gastroparesis, orthostatic hypotension, lactation, carbidopa-levodopa intolerance, and pediatric reflux in over one-hundred countries around the world excluding the United States. The US FDA prohibited domperidone in 2004 due to several reported cases of cardiac arrhythmia, cardiac arrest, or sudden cardiac death in patients using domperidone intravenously. There are no FDA approved treatments with established long-term safety and efficacy in parkinsonian or tardive dyskinesia patients for chronic nausea or gastroparesis (and metoclopramide is known to exacerbate these movement disorders.) Methods: Retrospective data was compiled using 101 patients from University of Utah Movement Disorder clinic who were prescribed oral domperidone. Patients were prescribed domperidone for the following indications: carbidopa-levodopa intolerance, orthostatic hypotension, or gastroparesis. Results: Domperidone was prescribed on 90.1[percnt] (91) patients for carbidopa-levodopa intolerances, 8.9[percnt] (9) for orthostatic hypotension and, 1.0[percnt] (1) for gastroparesis. The most commonly prescribed dose of domperidone was 10mg three times per day. Domperidone improved target symptoms in 86.1[percnt] (87) of patients, and only one potential cardiac event (dizziness) was observed. Domperidone was discontinued in 12.9[percnt] (13) of patients due to the following reasons: possible cardiac event, ineffectiveness, discontinuation of carbidopa-levodopa, resolution of symptoms, and use of alternative therapy. Conclusions: New regulations prohibit patients from receiving manufactured or compounded domperidone in the United States. Our retrospective chart review provides class U evidence that oral domperidone is effective and well-tolerated in treatment of carbidopa-levodopa intolerance, gastroparesis, and orthostatic hypotension in movement disorder patients. It is unclear if the observed cardiac event (dizziness) was associated with domperidone which was discontinued. Domperidone is worthy of further definitive trials in movement disorder patients to establish its safety and efficacy. Disclosure: Dr. Saminejad has nothing to disclose. Dr. fagatele has nothing to disclose. Dr. Wong has nothing to disclose. Dr. Budo has nothing to disclose. Dr. Shprecher has received personal compensation for activities with Teva Neuroscience has a consultant.