GSK's Avandia banned in Europe on heart worries

Glaxosmithkline was dealt a blow last night when European regulators recommended that its blockbuster diabetes drug, Avandia, should be withdrawn from sale amid fears that the treatment could pose serious health risks.

The European Medicines Agency (EMA) said that Avandia, which is used to treat Type-2 diabetes, should be withdrawn from sale after scientific studies discovered a link between the drug and an increased risk of heart attacks.

The US Food and Drug Administration, the body that sanctions medicines for use the United States, also released a statement in conjunction with EMA, saying that it had reached the same scientific conclusions as the European body but was prepared to allow the drug to stay on the market.

Doctors in Europe will now be instructed to prescribe alternative drugs to patients taking Avandia. EMA added that the suspension will remain in place unless convincing data are provided by GSK that identify a group of patients in whom the benefits of the medicine outweigh its risks.

In the US, GSK's biggest market, Avandia will still be available, but GSK will be required to detail the risks of the medicine in greater detail.

"I'm surprised the European agency has decided to remove the product from the market," said Savvas Neophytou, an analyst at Panmure Gordon. "I'm not entirely sure there is a massive difference in the response, although one sounds more draconian in that they're withdrawing the product. The restrictions imposed on the product used in the US are effectively the same.

"I expect this decision, although a lot of the impact of the Avandia franchise in the Glaxo investment thesis has been greatly reduced because of what has happened already over the last three years, could lead to some 3 per cent or so downgrades [on profits]."

Avandia was once GSK's second-biggest revenue earner, raking in $3bn a year. However, since 2007, when a paper published by The New England Journal of Medicine, written by respected cardiologist Steve Nissen, cast doubts over its safety, the group has gradually lost revenue on Avandia. In the first half of 2010, Avandia sales had slipped to £321m, an 18 per cent fall on the same period in 2009.

GSK said that it would work with both sets of regulators.

Ellen Strahlman, GSK's chief medical officer, said: "The company continues to believe that Avandia is an important treatment for patients with Type-2 diabetes and is now working with the FDA and EMA to implement the required actions. GSK will also work closely with other regulatory agencies to comply with any decisions made by them regarding [Avandia]."

In July, GSK set aside £1.57bn to meet outstanding legal charges, including a provision to meet claims over Avandia.

It refused to comment on reports earlier in the same week that it had agreed to pay out $460m to settle a number of cases.

Start your day with The Independent, sign up for daily news emails
ebooksAn unforgettable anthology of contemporary reportage
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
Independent Dating

By clicking 'Search' you
are agreeing to our
Terms of Use.

iJobs Job Widget
iJobs Money & Business

Recruitment Genius: Digital Optimisation Executive - Marketing

£30000 - £35000 per annum: Recruitment Genius: The UK's fastest growing, multi...

Recruitment Genius: Financial Reporting Manager

£70000 - £90000 per annum: Recruitment Genius: A Financial Reporting Manager i...

Recruitment Genius: Payments Operations Assistant

£23000 - £25000 per annum: Recruitment Genius: They win lots of awards for the...

Recruitment Genius: Telephone Debt Negotiator

£13500 - £20000 per annum: Recruitment Genius: This nationwide enforcement com...

Day In a Page

Syria civil war: Meet the military commander who says his soldiers will not rest until every inch of their war torn country is free of Islamist 'terrorists'

‘We won’t stop until Syria is back to normal’

Near the front lines with Islamist-controlled towns where Assad’s troops were besieged just last month, Robert Fisk meets a commander confidently preparing his soldiers for battle
The inside story of how Bill Clinton built a $2bn global foundation may undermine Hillary's chances

The inside story of how Bill Clinton built a $2bn global foundation...

... and how it may undermine Hillary's chances in 2016
12 best olive oils

Extra-virgin, cold-press, early-harvest, ultra-premium: 12 best olive oils

Choosing an olive oil is a surprising minefield. Save yourself the hassle with our handy guide
Rafa Benitez Real Madrid unveiling: New manager full of emotion at Bernabeu homecoming

Benitez full of emotion at Bernabeu homecoming

There were tears in the former Liverpool manager’s eyes as he was unveiled as Real Madrid coach. But the Spaniard knows he must make tough decisions if he is to succeed
Sepp Blatter resignation: The beginning of Fifa's long road to reform?

Does Blatter's departure mean Fifa will automatically clean up its act?

Don't bet on it, says Tom Peck
Charles Kennedy: The baby of the House who grew into a Lib Dem giant

The baby of the House who grew into a Lib Dem giant

Charles Kennedy was consistently a man of the centre-left, dedicated to social justice, but was also a champion of liberty and an opponent of the nanny-state, says Baroness Williams
Syria civil war: The harrowing testament of a five-year-old victim of this endless conflict

The harrowing testament of a five-year-old victim of Syria's endless civil war

Sahar Qanbar lost her mother and brother as civilians and government soldiers fought side by side after being surrounded by brutal Islamist fighters. Robert Fisk visited her
The future of songwriting: How streaming is changing everything we know about making music

The future of songwriting

How streaming is changing everything we know about making music
William Shemin and Henry Johnson: Jewish and black soldiers receive World War I Medal of Honor amid claims of discrimination

Recognition at long last

Jewish and black soldiers who fought in WWI finally receive medals after claims of discrimination
Beating obesity: The new pacemaker which helps over-eaters

Beating obesity

The new pacemaker which helps over-eaters
9 best women's festival waterproofs

Ready for rain: 9 best women's festival waterproofs

These are the macs to keep your denim dry and your hair frizz-free(ish)
Cycling World Hour Record: Nervous Sir Bradley Wiggins ready for pain as he prepares to go distance

Wiggins worried

Nervous Sir Bradley ready for pain as he prepares to attempt cycling's World Hour Record
Liverpool close in on Milner signing

Liverpool close in on Milner signing

Reds baulk at Christian Benteke £32.5m release clause
On your feet! Spending at least two hours a day standing reduces the risk of heart attacks, cancer and diabetes, according to new research

On your feet!

Spending half the day standing 'reduces risk of heart attacks and cancer'
With scores of surgeries closing, what hope is there for the David Cameron's promise of 5,000 more GPs and a 24/7 NHS?

The big NHS question

Why are there so few new GPs when so many want to study medicine?