Medication Guides are paper handouts that come with many prescription 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 adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:
- certain information is necessary to prevent serious adverse effects
- patient decision-making should be informed by information about a known serious side effect with a product, or
- patient adherence to directions for the use of a product are essential to its effectiveness.
Medication Guides are available for these products:
*biologic or drug/biologic combination
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- Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS (PDF - 91KB)
Final version (11/17/2011)
- Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS
- Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007