Other safety alerts
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| The United States: Rosiglitazone-containing diabetes medicines: Drug Safety Communication - FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) |
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FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.
Type 2 diabetes is a disease that can lead to serious complications such as kidney failure, blindness, and premature death. Rosiglitazone can be used along with diet and exercise to control blood sugar in adults with the disease.
In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea. FDA also required the drug manufacturers to provide educational training to health care professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines. Manufacturers have since fulfilled these requirements.
FDA has continued monitoring these medicines and identified no new pertinent safety information. FDA will update the public if any new information becomes available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm477601.htm
In Hong Kong, there are eight registered pharmaceutical products containing rosiglitazone, which are approved as Avandia (3 products) and Avandamet (5 products). All these products are registered by GlaxoSmithKline Ltd. (GSK), and are prescription-only medicines. Related news on the safety of rosiglitazone was previously issued by various overseas regulatory authorities, and was posted on the Drug Office website since 2010, with the latest update posted on 26 November 2013. So far, the Department of Health (DH) has not received any adverse drug reaction case related to rosiglitazone. In December 2012, the Registration Committee of the Pharmacy and Poisons Board discussed the safety and US REMS requirements for rosiglitazone, and endorsed GSK's proposed Rosiglitazone-containing Medicines Access Program (RAP) for implementation in Hong Kong (similar to the US REMS). In view of the US FDA's latest announcement to eliminate the REMS requirements, DH has made contact with GSK for their latest position on their issue, and their reply is pending. DH will follow-up with GSK and will continue to monitor the safety of rosiglitazone.
Ends/ Thursday, December 17, 2015
Issued at HKT 13:00
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