Warning over widely used diabetes drug

A widely used diabetes drug should not be issued to new patients after fears it increases the likelihood of heart attacks and strokes, a regulator said today.

The European Medicines Agency's (EMA) committee on medicinal products for human use decided Avandia's benefits no longer outweighed its risks.



The EMA committee said marketing of the product should be suspended and no further prescriptions issued while the suspension is in place.



Professor Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said: "Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone."



He said patients currently receiving the drug should have their treatment plans reviewed and changed where appropriate.



In a separate ruling, the US Food and Drug Administration said access to the pill should also be restricted.



It ruled new patients would only get a prescription for Avandia if they could not control their diabetes with other medications.



The drug was once the top-selling diabetes pill in the world but use plummeted after a 2007 analysis linked it to heart attack risks.



GlaxoSmithKline (GSK), which produces the drug, said the company continued to believe it was an important treatment.



Dr Ellen Strahlman, GSK's chief medical officer, said: "Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients."



The MHRA said tests had taken place on Avandia, which contains rosiglitazone, and advice had also been sought from the UK's Commission on Human Medicines (CHM).



In July, the CHM said the risks of rosiglitazone "outweighed its benefits and that it no longer had a place on the UK market".



An MHRA spokesman said: "The CHM considered action should be taken promptly and ideally within the appropriate EU framework, and it is this process which has led to today's suspension."



Simon O'Neill, of health charity Diabetes UK, said: "We are recommending that people with diabetes currently taking Avandia get in touch with their healthcare team as a matter of urgency to discuss their treatment options.



"We would not advise them to stop taking their medication in the meantime even if they are experiencing adverse side effects, such as swollen ankles or breathlessness, as it is very important that people with diabetes keep their blood glucose under control to prevent short and long term complications."



He added: "We welcome that a decision has been made about Avandia so people can now be supported to change on to an alternative treatment. We would urge the EMA to make swifter decisions in the future to ensure patient safety."

PROMOTED VIDEO
Life and Style
ebookNow available in paperback
ebooks
ebookPart of The Independent’s new eBook series The Great Composers
Life and Style
Suited and booted in the Lanvin show at the Paris menswear collections
fashionParis Fashion Week
News
i100
Arts and Entertainment
Kara Tointon and Jeremy Piven star in Mr Selfridge
tvActress Kara Tointon on what to expect from Series 3
Voices
Winston Churchill, then prime minister, outside No 10 in June 1943
voicesA C Benson called him 'a horrid little fellow', George Orwell would have shot him, but what a giant he seems now, says DJ Taylor
News
i100
News
An asteroid is set to pass so close to Earth it will be visible with binoculars
news
News
Latest stories from i100
Have you tried new the Independent Digital Edition apps?

ES Rentals

    Independent Dating
    and  

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

    iJobs Job Widget
    iJobs General

    Austen Lloyd: Private Client Solicitor - Oxford

    Excellent Salary : Austen Lloyd: OXFORD - REGIONAL FIRM - An excellent opportu...

    Austen Lloyd: Clinical Negligence Associate / Partner - Bristol

    Super Package: Austen Lloyd: BRISTOL - SENIOR CLINICAL NEGLIGENCE - An outstan...

    Recruitment Genius: Sales Consultant - Solar Energy - OTE £50,000

    £15000 - £50000 per annum: Recruitment Genius: Fantastic opportunities are ava...

    Recruitment Genius: Compute Engineer

    Negotiable: Recruitment Genius: A Compute Engineer is required to join a globa...

    Day In a Page

    Syria crisis: Celebrities call on David Cameron to take more refugees as one young mother tells of torture by Assad regime

    Celebrities call on David Cameron to take more Syrian refugees

    One young mother tells of torture by Assad regime
    The enemy within: People who hear voices in their heads are being encouraged to talk back – with promising results

    The enemy within

    People who hear voices in their heads are being encouraged to talk back
    'In Auschwitz you got used to anything'

    'In Auschwitz you got used to anything'

    Survivors of the Nazi concentration camp remember its horror, 70 years on
    Autumn/winter menswear 2015: The uniforms that make up modern life come to the fore

    Autumn/winter menswear 2015

    The uniforms that make up modern life come to the fore
    'I'm gay, and plan to fight military homophobia'

    'I'm gay, and plan to fight military homophobia'

    Army general planning to come out
    Iraq invasion 2003: The bloody warnings six wise men gave to Tony Blair as he prepared to launch poorly planned campaign

    What the six wise men told Tony Blair

    Months before the invasion of Iraq in 2003, experts sought to warn the PM about his plans. Here, four of them recall that day
    25 years of The Independent on Sunday: The stories, the writers and the changes over the last quarter of a century

    25 years of The Independent on Sunday

    The stories, the writers and the changes over the last quarter of a century
    Homeless Veterans appeal: 'Really caring is a dangerous emotion in this kind of work'

    Homeless Veterans appeal

    As head of The Soldiers' Charity, Martin Rutledge has to temper compassion with realism. He tells Chris Green how his Army career prepared him
    Wu-Tang Clan and The Sexual Objects offer fans a chance to own the only copies of their latest albums

    Smash hit go under the hammer

    It's nice to pick up a new record once in a while, but the purchasers of two latest releases can go a step further - by buying the only copy
    Geeks who rocked the world: Documentary looks back at origins of the computer-games industry

    The geeks who rocked the world

    A new documentary looks back at origins of the computer-games industry
    Belle & Sebastian interview: Stuart Murdoch reveals how the band is taking a new direction

    Belle & Sebastian is taking a new direction

    Twenty years ago, Belle & Sebastian was a fey indie band from Glasgow. It still is – except today, as prime mover Stuart Murdoch admits, it has a global cult following, from Hollywood to South Korea
    America: Land of the free, home of the political dynasty

    America: Land of the free, home of the political dynasty

    These days in the US things are pretty much stuck where they are, both in politics and society at large, says Rupert Cornwell
    A graphic history of US civil rights – in comic book form

    A graphic history of US civil rights – in comic book form

    A veteran of the Fifties campaigns is inspiring a new generation of activists
    Winston Churchill: the enigma of a British hero

    Winston Churchill: the enigma of a British hero

    A C Benson called him 'a horrid little fellow', George Orwell would have shot him, but what a giant he seems now, says DJ Taylor
    Growing mussels: Precious freshwater shellfish are thriving in a unique green project

    Growing mussels

    Precious freshwater shellfish are thriving in a unique green project