Details
Tardive dyskinesia (TD) is a known safety risk with use of metoclopramide. During the review of an application for a nasal spray formulation of metoclopramide for use in diabetic gastroparesis, FDA wanted to understand the duration of use, since the risk of developing TD increases with duration of treatment and cumulative dosage. To understand real-world use patterns of metoclopramide, FDA conducted an analysis on the treatment episode duration, number, frequency, and cumulative dose among users of other available metoclopramide dosage forms, which had labeled recommended durations of use of 8 weeks or less. Among women ages ≥ 40 years identified in the Sentinel Distributed Database between January 1, 2009 and September 30, 2015, there were over 1.4 million users of metoclopramide. Of the 3.7% of these women with diabetic gastroparesis, approximately 25% had metoclopramide treatment episodes longer than 4 weeks. These data provided context for FDA’s assessment of the application by providing information about the potential for the target population to use a nasal metoclopramide product outside the parameters supported by the available safety data.