Diabetes drug still available despite suspension advice

Avandia pills GlaxoSmithKline is the world's third largest pharmaceutical company

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A drug for type two diabetes is still being prescribed in the UK despite being recommended for withdrawal two months ago, BBC Panorama has found.

Avandia has been linked to a raised risk of heart attacks and heart failure and is under a Europe-wide review.

An expert panel of the UK Medicines and Healthcare products Regulatory Agency (MHRA) said its use should be suspended but it is still available on the NHS.

Manufacturer GlaxoSmithKline (GSK) said it was safe if properly monitored.

'Alternative treatments'

Tens of thousands of patients take Avandia, also known as Rosiglitazone. It was prescribed more than one million times in the UK last year alone.

  • Panorama: A Risk Worth Taking? is broadcast on BBC One, Monday 6 September at 2030 BST or watch again on BBC iPlayer

Pharmaceutical giant GSK said its research programme proved the drug was "safe and effective when it is prescribed appropriately".

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 following the advice it sent letters to healthcare professionals asking them to "consider alternative treatments where appropriate".

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.

The drug is meant to improve life for type two diabetics by helping to regulate blood sugar levels but there is also evidence it could increase the risk of heart failure and heart attacks.

Swelling

"Doctors were advised not to use the tablet in anyone who was at risk of heart failure," said Prof Edwin Gale, a leading UK diabetes expert.

Main types of heart condition

  • A heart attack happens when one of the coronary arteries becomes blocked by a blood clot. This cuts off the supply of blood and oxygen to the heart, causing damage to the heart muscle. This is most likely to happen if you are older, male, a smoker, overweight or have high cholesterol or high blood pressure
  • Heart failure is quite a misleading term and would probably be better called 'heart inefficiency'. It refers to the heart's job as a pump. The heart squeezes a set amount of blood each time it beats. If you have heart failure, the pump is less efficient and cannot cope with squeezing the same amount each time. It does not mean your heart is about to stop at any time - it means it isn't working as well as it should
  • A cardiac arrest is the technical term for when the heart suddenly stops pumping blood around the body. This may be due to an erratic heart rhythm that can sometimes be corrected by defibrillation or 'shocking' the heart.

Source: British Heart Foundation

Prof Gale, who chairs the European Medicines Agency scientific advisory group on diabetes, said Avandia should be withdrawn entirely.

"How long do you wait? How important is it to be absolutely certain and at what point do you start saying - this game isn't worth it, people's lives may be at risk, something should be done about it?" he said.

Clinical pharmacologist Dr Yoon Loke, of the University of East Anglia, said his analysis of the class of drug showed that it doubled the risk of heart failure, regardless of whether or not the patients were considered at high risk before they took the drug.

"Even if you restricted it to patients who don't have heart failure, you will still get patients who newly develop heart failure as a result of Avandia," Dr Loke said.

He has calculated that annually in the UK patients could suffer "about 1,000 extra heart attacks and possibly 600 extra cases of heart failure too as a result of using Avandia".

Launched in Europe 10 years ago, Avandia quickly became the market-leading diabetes tablet, earning GSK billions of pounds.

Usha Patel has diabetes and used the drug to manage her condition. But when she developed painful conditions including swelling in her legs and further tests showed that she had developed heart problems, her GP advised her to stop taking Avandia.

"Because of your heart problems, we don't want you to take any more tablets," her GP told her. "Stop it the next day. Don't take it any more."

'First priority'

Other patients Panorama spoke to have had a more positive experience with their Avandia prescription.

US diabetes sufferer Charlene Young said her heart attack "was devastating"

Helen Lovatt was first prescribed the drug by her GP six years ago and thinks that, together with her recent weight loss, it has helped bring her diabetes under control.

"It suits me, doesn't upset me in any way so if it's not broken why mend it?

"I saw in the paper about the possible side effects, but if my doctor's keeping a good check on me, I'm not going to sit and worry about it," she said.

In response to Panorama's findings, GSK said: "Patient safety is our first priority.

"We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia and continue to believe it is safe and effective when it is prescribed appropriately."

The Europe-wide review by the European Medicines Agency into Avandia will announce findings whether to restrict its prescription or withdraw it completely later this month.

Panorama: A Risk Worth Taking? is broadcast on BBC One, Monday 6 September at 2030 BST.

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