European Medicines Agency starts review of rosiglitazone-containing medicines, as FDA releases briefing documents; EMEA reviews way forward for the Ag
The European Medicines Agency (EMEA) said last Friday that it has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia from UK drugs giant GlaxoSmithKline, as well as the drug sold in combination with metformin (Avandamet) and with glimepiride (Avaglim), to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile.
In the USA, where questions about Avandia's safety first started with reports in the .New England Journal of Medicine and strong criticism from various Senators and FDA scientists (The Pharma Letters passim), the US Food and Drug Administration has issued briefing documents ahead of scheduled advisory committee meetings on July 13-14, to decide if the drug should remain on the market and, if so, with what warnings.
RECORD and TIDE trials still questioned
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