GlaxoSmithKline's Avandia still available in UK, despite MHRA call for its suspension

7 September 2010

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical