Other safety alerts
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| The United States: Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions |
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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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm376683.htm
In Hong Kong, there are 8 registered pharmaceutical products containing rosiglitazone, namely Avandia Tiltab Tab 2mg (HK-47006), 4mg (HK-47007), 8mg (HK-47008), Avandamet Tab 1mg/500mg (HK-51300), 2mg/500mg (HK-51301), 4mg/500mg (HK-51302), 4mg/1000mg (HK-53135) and 2mg/1000mg (HK-53136). All products are registered by GlaxoSmithKline Ltd. (GSK) and are prescription only medicines. Currently, only Avandia Tiltab Tab 4mg (HK-47007) is marketed in Hong Kong. Safety updates on rosiglitazone were previously released by the US,UK,Canada and EU health authorities and were posted on the Drug Office website on 20 April, 23 July, 24 September, 5 October and 19 November 2010; and on 7 February, 19 May and 7 November 2011. The Registration Committee of the Pharmacy and Poisons Board discussed these safety updates in October 2010, June 2011 and December 2012 and decided that GSK must implement a restricted access and distribution programme for the supply of rosiglitazone products. Drug Office will remain vigilant on further new safety updates on rosiglitazone by other overseas health authorities for consideration of any necessary actions by the Registration Committee.
Ends/ Tuesday, November 26, 2013
Issued at HKT 14:00
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