Medication Guides are paper handouts that come with many instruction medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious bad events. FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:
1. certain information is necessary to prevent serious adverse effects
2. patient decision-making should be informed by information about a known serious side effect with a product, or
3. patient obedience to directions for the use of a product are essential to its effectiveness.