Other safety alerts
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| The United States: Avandia (rosiglitazone): [updated 05／18／2011] REMS - risk of cardiovascular events |
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FDA notified healthcare professionals and the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs. FDA has modified the REMS (risk evaluation and mitigation strategies) for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm
In Hong Kong, Avandia, Avandamet and Avandaryl are registered by GlaxoSmithKline Ltd (GSK), and there are a total of 15 products containing rosiglitazone registered. All of these products are prescription drugs. The issue was discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board on October 4, 2010. The Committee decided that rosiglitazone should not be used in all patients with heart failure, or history of heart failure, and that rosiglitazone should only be used in patients with Type 2 diabetes who cannot control their diabetes on other medications. This information had been posted onto the website of pharmaceutical service and healthcare professional letter was issued on the same day. In view of FDA's new requirement, the issue will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, May 19, 2011
Issued at HKT 12:30
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