It's been a while since the US FDA had a meeting of an Advisory Committee to discuss the future in the United States of the diabetes drug rosiglitazone (brand name Avandia), way back in July. Now it's the European's turn to shine the light on rosiglitazone and its troubled safety record:
All this in advance of a meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on September 8 to discuss the "ongoing benefit-risk review" of Avandia.
Shortly after the FDA AdComm meeting, the EMA posted a press release in which doctors were reminded "to follow current restrictions for rosiglitazone-containing anti-diabetes medicines until further notice" - namely, that "rosiglitazone must not be used in patients with current or previous heart failure and in patients with acute coronary syndrome; rosiglitazone and insulin should only be used together in exceptional cases and under close supervision; [and] the use of rosiglitazone is not recommended in patients with ischaemic heart disease or peripheral arterial disease."
Will the EMA actually pull Avandia from the European market? It's quite unclear; the EMA only states that "After the meeting, the Agency will make public the next steps agreed by the Committee." We're still waiting for the ponderous FDA bureaucracy to react to the July Advisory Committee recommendations; I wonder whether the EMA will react any faster than the FDA.
In the meantime, a reminder: as I've said before, anybody who is taking Avandia should not discontinue the medication without first consulting their physician.