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Avandia Message from Dr Ellen Strahlman, Chief Medical Officer GSK

Dr Ellen Strahlman

Video transcript: Hello. My name is Ellen Strahlman, and I am the Chief Medical Officer at GlaxoSmithKline. I’m responsible for maintaining the highest standards of medical governance, ethics and integrity across GSK.

Regulatory authorities in Europe and the US have been reviewing the efficacy and safety of Avandia. This week, they made decisions that will affect all patients in Europe and the US who are currently taking Avandia, Avandamet, Avaglim or Avandaryl, and so I wanted to take this opportunity to talk to you directly.

The European Medicines Agency has informed GSK that it is suspending the marketing authorisation for all rosiglitazone-containing products in the European Union, and this includes Avandia, Avandamet and Avaglim. The EMA is the regulatory agency responsible for deciding which medicines should be available for doctors in Europe to prescribe for their patients. And as a result of this decision, physicians will no longer be able to prescribe these medications.

If you are a patient in Europe currently taking any of these medicines, you should contact your physician at the earliest opportunity to discuss switching to alternative treatment options.

The US Food and Drug Administration has also been reviewing the safety of Avandia. They’ve directed that GSK revise the label for Avandia, Avandamet and Avandaryl to include additional warnings and precautions. In addition, the FDA has also determined that GSK should implement a Risk Evaluation and Mitigation Strategy programme for the medicine, which would include restricting physician prescribing of the medicine to a named patient basis.

Again if you are a patient with Diabetes taking any of these medicines, do not stop taking your medication, but please contact your healthcare professional at the earliest opportunity to discuss the possible impact on your treatment.

Our primary concern are our patients with type 2 diabetes. GSK is working closely with the regulatory authorities and healthcare professionals to implement the changes. And we are making every effort to ensure that physicians and other healthcare professionals have all the information they need to help them understand how this affects their patients and what they should do next.

You may be wondering why the regulatory authorities in Europe and the US have reached their decisions now. I can't speak on their behalf, but what I can do is explain GSK's position to you.

All medicines have risks as well as benefits which need to be evaluated in the context of the diseases that they aim to treat. It's the regulators' responsibility to review these risks and benefits and to come to a decision as to which medicines should be available for physicians to prescribe for their patients. We recognise that this is an important and at times, difficult job.

Regarding Avandia, you may also be aware that there has recently been a rigorous scientific debate about the medicine, which has resulted in a divergence of scientific opinion about its possible benefits and risks.

As a company, we believe that Avandia has helped millions of people manage their diabetes, and that it is a safe and effective treatment option when used appropriately.

As I mentioned earlier we will work with the regulatory authorities in Europe and the US, in the best interests of patients, implementing the actions they have requested of us.

I recognise that this will be a difficult and worrying time for anyone affected by the decisions announced today. And if you’d like further information, please visit our website at www.gsk.com.

At GSK patient safety comes first. If you are someone with type 2 Diabetes taking any of these medicines, again please, do not stop taking your medicine, but contact your healthcare professional at your earliest convenience to discuss the impact of these decisions on your treatment.

And thank you for your time.

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