Opinion ID: 2832576
Heading Depth: 4
Heading Rank: 2

Heading: Reglan Manufacturer’s Package Insert

Text: During Defendant’s testimony, a printout of the FDA version of the Reglan manufacturer’s package insert in effect at 8  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  the time (“manufacturer’s insert”) was entered into evidence over objection.7 The manufacturer’s insert states, in relevant part, as follows: CONTRAINDICATIONS [Reglan] should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction or perforation. . . . . Pediatric Use Safety and effectiveness in pediatric patients have not been established (see OVERDOSAGE). . . . . The safety profile of [Reglan] in adults cannot be extrapolated to pediatric patients. . . . . ADVERSE REACTIONS In general, the incidence of adverse reactions correlates with the dose and duration of [Reglan] administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: . . . . Gastrointestinal Nausea and bowel disturbances, primarily diarrhea.