Avandia Restriction in US, Suspension in Europe, Philipines Just Wait?


In recent developments, GlaxoSmithKline's Avandia (rosiglitazone)—a widely used diabetes drug—the U.S. Food and Drug Administration had announced on Thursday that it will 'significantly restrict the use of the drug Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications.'

The FDA's action is related to a data that suggests an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

Meanwhile, the European Medicines Agency (EMA) has recommended that Avandia along with other anti-diabetes drugs including Avandamet and Avaglim be suspended. The EMA says, "The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone."

In the Philippines, the Department of Health (DOH) or the Bureau of Food and Drugs (BFAD) now known as FDA has not yet announced today Friday about its position on these recent developments (As always!?).

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