Microsoft word - rosiglitazone safety information 11-26-13.docx
Rosiglitazone Products—Removal of Some Dispensing Restrictions
November 25, 2013
The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI). Previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks. Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, FDAs concern is substantially reduced and the rosiglitazone REMS program requirements will be modified. FDA is also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information. Rosiglitazone is a treatment option that can improve blood sugar control in some patients with type 2 diabetes. Patients with type 2 diabetes should continue to work closely with their health care professionals to determine treatment options that are most appropriate. Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines. As part of the REMS, sponsors will ensure that health care professionals who are likely to prescribe rosiglitazone medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of rosiglitazone medicines. Manufacturers will also send Dear Healthcare Provider and Dear Professional Society letters to educate prescribers about the new information. Healthcare professionals and patients are encouraged to report any adverse events or side effects related to the use of this product and/or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
9 Complete and submit the report online: www.fda.gov/MedWatch/report.htm 9 Complete and return a form by mail (address on the pre-addressed form) or fax (1-800-FDA-0178).
[Call 1-800-332-1088 to request a reporting form or download a form at
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NitroMist safely and effectively. • Increased intracranial pressure (4.3) See full prescribing information for NitroMist. • History of hypersensitivity to NitroMist or to other nitrates or nitrites (4.4) NitroMist® (nitroglycerin) lingual aerosol WARNINGS AND PRECAUTIONS
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