GlaxoSmithKline (GSK) Pharmaceutical Sdn Bhd has updated the Drug Control Authority of the Health Ministry on the decision taken by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regarding the drug Avandia.
The company said it would continue to work closely with the authority on its evaluation of the drug.
The statement was issued following the statement by Health Ministry director-general Tan Sri Dr Ismail Merican on Sunday urging prescribers to restrict the use of the drug, also known as rosiglitazone, and not initiate the medicine on any new patients.
Dr Ismail said diabetic patients, who were currently on the drug, should seek advice from their doctors on whether to continue taking the medicine. To access the full EMA announcement, visitwww.ema.europa.eu while updates on the full FDA announcement can be accessed at www.fda.gov.
On Sept 23, the European Medicines Agency had recommended the suspension on the use of rosiglitazone (Avandia) and rosiglitazone containing anti-diabetes medicines Avandamet (combination of rosiglitazone/ metformin) and Ava glim (combination of rosiglitazone/ glimipride).
This followed data related to an increased cardiovascular risk after the use of this medicine. Rosiglitazone is approved as an adjunct to diet and exercise for improving glycaemic control in patients with type 2 diabetes mellitus.
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 (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes).
The company said it would continue to work closely with the authority on its evaluation of the drug.
The statement was issued following the statement by Health Ministry director-general Tan Sri Dr Ismail Merican on Sunday urging prescribers to restrict the use of the drug, also known as rosiglitazone, and not initiate the medicine on any new patients.
Dr Ismail said diabetic patients, who were currently on the drug, should seek advice from their doctors on whether to continue taking the medicine. To access the full EMA announcement, visitwww.ema.europa.eu while updates on the full FDA announcement can be accessed at www.fda.gov.
On Sept 23, the European Medicines Agency had recommended the suspension on the use of rosiglitazone (Avandia) and rosiglitazone containing anti-diabetes medicines Avandamet (combination of rosiglitazone/ metformin) and Ava glim (combination of rosiglitazone/ glimipride).
This followed data related to an increased cardiovascular risk after the use of this medicine. Rosiglitazone is approved as an adjunct to diet and exercise for improving glycaemic control in patients with type 2 diabetes mellitus.
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 (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes).
