Avandia in Europe   (September 6, 2010)

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:

* The BBC's Panorama show ("The world's longest running investigative TV show") is airing a program titled A Risk Worth Taking? on BBC One today (September 6). The program apparently implies that UK regulators are ready to withdraw the drug from the market.

* In an on-line review published today, titled Rosiglitazone: what went wrong?, the British Medical Journal has a detailed history of rosi, and points out that the FDA is a model of transparency compared to the UK and other European regulators: "Trying to gain an overall perspective of deliberations within the EMA [European Medicines Agency] has been far trickier. The BMJ  attempted to speak to people who had sat on panels for the MHRA and the EMA. But they were bound by confidentiality clauses. The EMA would not release the names of the members of the scientific advisory group discussing rosiglitazone under the Freedom of Information Act. Secrecy also shrouds the UK's regulatory agency."

* Additionally, a news story yesterday claims that the British Medical Journal's Editor-in-Chief has called for Avandia to be pulled from the market (but the BMJ website does not include any such statement as of today).

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.