Other safety alerts
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| European Union and United States: Rosiglitazone |
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Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone.
Situation in the European Union
The European Medicines Agency recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months. Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor. The suspension will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks. The Committee’s recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision. In the United Kingdom, the Commission on Human Medicines had also concluded that the benefits of rosiglitazone no longer outweigh its risks, and recommended withdrawal from clinical use.
Situation in the United States
The United States Food and Drug Administration (FDA) announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. The FDA also ordered GSK to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During the course of the FDA’s review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings. In addition, the agency halted the GSK’s clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs. The FDA may take additional actions after the independent re-analysis of RECORD is completed.
The data underlying the cardiovascular ischemic risks of rosiglitazone are concerning, but they are not definitive. For those patients who cannot effectively control their blood sugar using alternative medications, the benefits of rosiglitazone may exceed these risks. Using rosiglitazone under these circumstances is a judgment that patients should make with their health care professionals. In addition, there are also individuals currently taking rosiglitazone who, with full knowledge of the potential risk and in consultation with their healthcare providers, may wish to remain on the drug rather than revise their treatment. FDA's action permits them to do so.
Situation in Hong Kong
Avandia, Avandamet and Avandaryl are registered in Hong Kong by GlaxoSmithKline Ltd (GSK), and there are a total of 17 products containing rosiglitazone registered in Hong Kong. A clinical trial RECORD is already completed, and the TIDE trial has not recruited any patients yet in Hong Kong and this trial will also be halted in Hong Kong. No other trials are being conducted. The status of rosiglitazone will be discussed by the Registration Committee of the Pharmacy and Poisons Board in its upcoming meeting in October 2010.
Please refer to the following websites for details:
1. The European Medicines Agency:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/09/news_detail_001119.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
2. The Medicines and Healthcare products Regulatory Agency
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON094127
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON094121
3. The United States Food and Drug Administration
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226975.htm
Ends/Friday, September 24, 2010
Issued at HKT 12:30
alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor. The suspension will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks. The Committee’s recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision. In the United Kingdom, the Commission on Human Medicines had also concluded that the benefits of rosiglitazone no longer outweigh its risks, and recommended withdrawal from clinical use.
Situation in the United States
The United States Food and Drug Administration (FDA) announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. The FDA also ordered GSK to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During the course of the FDA’s review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings. In addition, the agency halted the GSK’s clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs. The FDA may take additional actions after the independent re-analysis of RECORD is completed.
The data underlying the cardiovascular ischemic risks of rosiglitazone are concerning, but they are not definitive. For those patients who cannot effectively control their blood sugar using alternative medications, the benefits of rosiglitazone may exceed these risks. Using rosiglitazone under these circumstances is a judgment that patients should make with their health care professionals. In addition, there are also individuals currently taking rosiglitazone who, with full knowledge of the potential risk and in consultation with their healthcare providers, may wish to remain on the drug rather than revise their treatment. FDA's action permits them to do so.
Situation in Hong Kong
Avandia, Avandamet and Avandaryl are registered in Hong Kong by GlaxoSmithKline Ltd (GSK), and there are a total of 17 products containing rosiglitazone registered in Hong Kong. A clinical trial RECORD is already completed, and the TIDE trial has not recruited any patients yet in Hong Kong and this trial will also be halted in Hong Kong. No other trials are being conducted. The status of rosiglitazone will be discussed by the Registration Committee of the Pharmacy and Poisons Board in its upcoming meeting in October 2010.
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