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Avandia (rosiglitazone) REMS (Risk Evaluation and Mitigation Strategy) document. |
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FDA: The goals of the Avandia-Rosiglitazone Medicines Access Program (hereafter referred to as the Rosiglitazone REMS Program) are:.................... 1. To restrict access to rosiglitazone-containing medicines (Avandia, Avandamet, Avandaryl) so that only prescribers who acknowledge the potential increased risk of myocardial infarction associated with the use of rosiglitazone are prescribing rosiglitazone................... 2. To restrict access to patients who have been advised by a healthcare provider about the potential increased risk of myocardial infarction associated with the use of rosiglitazone and are one of the following:................ • either already taking rosiglitazone or............... • if not already taking rosiglitazone, they are unable to achieve glycemic control on other medications and, in consultation with with their healthcare provider, have decided not to take pioglitazone for medical reasons.
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