Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines. This update is in follow-up to the FDA Drug Safety Communications (or DSCs) issued on November 4, 2011 and May 18, 2011
Sonia Kim, a pharmacist in the Division, will provide you with additional information about this communication.
Dr Kim: On November 25th, 2013 the U.S. Food and Drug Administration issued a DSC notifying the public it 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, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on our 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.
Type 2 diabetes is a disease that can lead to serious complications and premature death. Rosiglitazone is a treatment option that can improve blood sugar control in some patients with the disease. Patients with type 2 diabetes should continue to work closely with their health care professionals to determine treatment options that are most appropriate.
FDA continues to evaluate the safety and effectiveness of drugs after they go on the market. In the case of rosiglitazone medicines, 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 we required a Risk Evaluation and Mitigation Strategy (or 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 (or RECORD) trial, our concern is substantially reduced and the rosiglitazone REMS program requirements will be modified. We are also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information.
Under FDA’s proposed modifications to the rosiglitazone REMS program:
- Distribution of the medicines will no longer be restricted. Rosiglitazone may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus.
- 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.
Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication as well as the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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FDA Drug Safety Podcast: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines mp3(MP3 - 4.2MB) FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines FDA requires removal of certain restrictions on the diabetes drug Avandia
- FDA Press Release: FDA requires removal of certain restrictions on the diabetes drug Avandia
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information