Diabetes drug warning
CHINA'S top drug regulator has warned of the possible dangers of using rosiglitazone, an anti-diabetes drug, after overseas tests showed it increased cardiovascular risks.
The State Food and Drug Administration said diabetics aged 65 and over and those yet to use the drug should only take rosiglitazone if they cannot control their diabetes with any other medication and if they are free of cardiovascular risks.
The decision will affect 12 Chinese producers of rosiglitazone, developed by GlaxoSmithKline, which was introduced to the Chinese market in 2000 and is available in more than 110 countries and regions.
The administration's announcement follows a similar decision by the US Food and Drug Administration in July to restrict rosiglitazone to patients with Type-2 diabetes who cannot treat their condition with any other medication. European Union drug regulators last month proposed suspension of the drug from its market.
The Chinese administration advised patients to have cardiovascular tests before deciding to continue rosiglitazone use and urged doctors to inform diabetics of possible side effects. Some reports indicated that rosiglitazone was linked to an increased risk of heart disease, but others had not reached that conclusion, the administration said.
The State Food and Drug Administration said diabetics aged 65 and over and those yet to use the drug should only take rosiglitazone if they cannot control their diabetes with any other medication and if they are free of cardiovascular risks.
The decision will affect 12 Chinese producers of rosiglitazone, developed by GlaxoSmithKline, which was introduced to the Chinese market in 2000 and is available in more than 110 countries and regions.
The administration's announcement follows a similar decision by the US Food and Drug Administration in July to restrict rosiglitazone to patients with Type-2 diabetes who cannot treat their condition with any other medication. European Union drug regulators last month proposed suspension of the drug from its market.
The Chinese administration advised patients to have cardiovascular tests before deciding to continue rosiglitazone use and urged doctors to inform diabetics of possible side effects. Some reports indicated that rosiglitazone was linked to an increased risk of heart disease, but others had not reached that conclusion, the administration said.
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