BEIJING - China's top drug regulator Saturday warned diabetics of the possible dangers of using rosiglitazone, an anti-diabetes drug, as overseas tests showed it increased cardiovascular risks.
The State Food and Drug Administration (SDFA) said in a statement that diabetics aged 65 and over and those yet to use the drug should only take rosiglitazone-containing medicines if they cannot control their diabetes with other medications and if they are free of cardiovascular risks.
The SDFA decision will affect 12 Chinese producers of rosiglitazone, developed by GlaxoSmithKline (GSK), which was introduced to the Chinese market in 2000 and is available in more than 110 countries.
The SDFA's announcement followed a similar decision by the US Food and Drug Administration in July to restrict the use of rosiglitazone to patients with Type-2 diabetes who cannot treat their diabetes on other medications.
European Union drug regulators last month proposed suspension of the drug from its market.
The SDFA advised patients to complete cardiovascular tests before they decide to continue rosiglitazone use and urged doctors to inform diabetics of possible side effects before prescription.
Some reports had indicated that rosiglitazone was linked to an increased risk of heart diseases, including heart attack or failure, and even deaths, but other reports had not reached the same conclusions, said the SDFA statement.