Ranitidine adverse events comparable to placebo, Glaxo reports.
This article was originally published in The Tan Sheet
Executive Summary
RANITIDINE ADVERSE EVENTS NEARLY INDISTINGUISHABLE FROM PLACEBO in a review of data from 189 controlled clinical trials, Glaxo Director-International Affairs John Wood, PhD, said in a presentation to a joint meeting of FDA's Nonprescription Drugs and Gastrointestinal Drugs Advisory Committees on July 13. He called the safety profile "embarrassing" in that he could "not differentiate placebo and ranitidine," and pointed to the survival of one patient who ingested the equivalent of 240 75 mg tablets as an illustration of "the high margin of safety in this molecule."