FDA issues first Medication Guide

The FDA announced in late August that it had developed a Medication Guide for the prescription drug Lotronex, which is used in treatment for a form of irritable bowel syndrome.

A Medication Guide is FDA-approved patient labeling containing information written especially for patients that explains the risks associated with the drug and what patients can do to help prevent that risk. Pharmacists are required to distribute the Guide with the product. The Lotronex Medication Guide will be attached to every bottle of the drug. Lotronex is the first drug to have a Medication Guide under regulations that became effective in 1999.

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