Cardiovascular Drug Product Medication Guides and REMS
Medication Guides are paper handouts that come with many prescription medicines. Medication 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.
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
The list below provides Medication Guides and in some cases REMS documents. Medication guides are linked to the drug product name. See FDA's Approved Risk Evaluation and Mitigation Strategies (REMS) page for additional information.
- Brilinta* (ticagrelor) [2011 version] – REMS
- Cordarone (amiodarone hydrochloride) [2011 version]
- Coumadin (warfarin sodium) [2010 version]
- Effient* (prasugrel) [2011 version] – REMS
- Juvisync (sitagliptin and simvastatin) [2011 version]
- Multaq* (dronedarone) [2011 version] – REMS
- Pacerone (amiodarone hydrochloride) [2008 version]
- Plavix (clopidogrel bisulfate) [2011 version]
- Pradaxa (dabigatran etexilate mesylate) [2012 version]
- Promacta (eltrombopag) [2011 version]
- Samsca* (tolvaptan) [2009 version] – REMS
- Tikosyn* (dofetilide) [2011 version] – REMS
- Tracleer* (bosentan) [2009 version] - REMS
- Trilipix (choline fenofibrate) [2011 version]
- Xarelto (rivaroxaban) [2011 version]