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
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
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
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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This informational summary is provided by American Health Care as a free service and does not constitute,
and is not intended to be construed as, medical or legal advice. For additional information regarding the summary,
please read the entire article. Any other questions may be directed to the originator.
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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