Despite an expert panel of the UK Medicines and Healthcare products Regulatory Agency (MHRA) calling for its use to be suspended a couple of months ago, GlaxoSmithKline's (GSK: L) diabetes drug Avandia (rosiglitazone) is still available on the National Health Service, a BBC television program has revealed. The continued debate about the drug - along with criticism from the British Medical - Journal, caused GSK's shares to fall 1.5% yesterday to £12.49, even before the program was aired.
According to the Panorama documentary, clinicians at the MHRA's advisory body, the Commission on Human Medicines (CHM), voted unanimously in July for Avandia's withdrawal from the UK. But the recommendation was not made public. The MHRA said that, following the advice, it sent letters to health care professionals asking them to "consider alternative treatments where appropriate," reminding them to closely observe the current contraindications and monitoring requirements for rosiglitazone. It also said it used the information to push for a UK withdrawal as part of the Europe-wide review by the European Medicines Agency (EMEA).
In its July 26 web posting, the MHRA said that new data have been published that raise concern about an increased risk of cardiovascular adverse effects of rosiglitazone. These data add substantially to existing evidence and point towards an increased cardiovascular risk with rosiglitazone compared with both placebo and with pioglitazone.
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