he Health Ministry wants doctors to restrict the use of anti-diabetic drugs containing rosiglitazone and stop starting new patients on such drugs over safety concerns.
Health Ministry director-general Tan Sri Dr Mohd Ismail Merican said in a statement on Sunday that the European Medicines Agency (EMA) on Thursday suspended the use of anti-diabetic drugs after a review by the Committee for Medical Products for Human Use (CHMP) of data about increased risk of adverse cardiovascular effects of rosiglitazone in anti-diabetic drugs like Avandia, Avandemet and Avaglim.
“The United States Food and Drug Administration (USFDA) has announced that it will restrict the use of rosiglitazone to patients with Type II diabetes who cannot control it with other medications.
“It has also ordered GlaxoSmithKline to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes),” he said.
He said USFDA would only take additional actions once the independent re-analysis of RECORD is completed.
“Aside from the current regulatory actions taken by USFDA and EMA, the Drug Control Authority (DCA) will like to recommend that prescribers restrict the use of the drug and not initiate this medicine on any new patients,” he said, adding current diabetic patients who were currently on rosiglitazone should seek advice from their doctors on whether they needed to continue taking it or otherwise.
He said DCA would continue to monitor and review any new safety information regarding this product for further regulatory action if needed.
Health Ministry director-general Tan Sri Dr Mohd Ismail Merican said in a statement on Sunday that the European Medicines Agency (EMA) on Thursday suspended the use of anti-diabetic drugs after a review by the Committee for Medical Products for Human Use (CHMP) of data about increased risk of adverse cardiovascular effects of rosiglitazone in anti-diabetic drugs like Avandia, Avandemet and Avaglim.
“The United States Food and Drug Administration (USFDA) has announced that it will restrict the use of rosiglitazone to patients with Type II diabetes who cannot control it with other medications.
“It has also ordered GlaxoSmithKline to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes),” he said.
He said USFDA would only take additional actions once the independent re-analysis of RECORD is completed.
“Aside from the current regulatory actions taken by USFDA and EMA, the Drug Control Authority (DCA) will like to recommend that prescribers restrict the use of the drug and not initiate this medicine on any new patients,” he said, adding current diabetic patients who were currently on rosiglitazone should seek advice from their doctors on whether they needed to continue taking it or otherwise.
He said DCA would continue to monitor and review any new safety information regarding this product for further regulatory action if needed.
