Diabetes Drug Product Medication Guides and REMS
Medication Guides and REMS for Diabetes Drug/Biologic Products
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.
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 hyperlinked to the drug product name.
Drugs that require manufacturers to ensure drug benefits outweigh its risks (REMS) are denoted with an asterisk. The REMS can be found on the Approved Risk Evaluation and Mitigation Strategies.
Medication Guides are available for these drug/biologicl products:
- Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2011 version] *
- Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
- Actos (pioglitazone hydrchloride) [2011 version]
- Avandamet (metformin hydrochloride and rosiglitazone maleate) [2011 version] *
- Avandaryl (glimepiride and rosiglitazone maleate) [2011 version] *
- Avandia (rosiglitazone maleate) [2011 version] *
- Bydureon (exenatide) [2012 version] *
- Byetta (exenatide) [2009 version]
- Janumet (metformin hydrochloride and sitagliptin phosphate) [2011 version]
- Januvia (sitagliptin phosphate) [2011 version]
- Juvisync (sitagliptin and simvastatin) [2011 version]
- Kombiglyze XR (metformin hydrochloride and saxagliptin) [2011 version]