Nexium label revision

Executive Summary

AstraZeneca revises the label for Nexium (esomeprazole) to update adverse events found in postmarketing use of the proton pump inhibitor. Possible side effects include "rare" cases of myalgia and hepatitis "with or without jaundice," the new label reads. AstraZeneca collected the adverse events through spontaneous reporting. Other PPI products such as TAP's Prevacid, Wyeth's Protonix and Proctor & Gamble's Prilosec OTC carry similar warnings. AstraZeneca is making the label change as promotions are underway for Nexium's use in combination with non-steroidal anti-inflammatory drugs (1"The Tan Sheet" May 9, 2005, p. 14)...