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."

Life and Style
ebookNow available in paperback
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

    Recruitment Genius: Web Developer - Junior / Middleweight

    Negotiable: Recruitment Genius: One of the South East's fastest growing full s...

    Guru Careers: Marketing Manager / Marketing Communications Manager

    £35-40k (DOE) + Benefits: Guru Careers: We are seeking a Marketing Communicati...

    Recruitment Genius: Commercial Engineer

    £30000 - £32000 per annum: Recruitment Genius: Estimating, preparation of tech...

    Recruitment Genius: IT Support Technician

    £14000 - £17000 per annum: Recruitment Genius: You will work as part of a smal...

    Day In a Page

    Blundering Tony Blair quits as Middle East peace envoy – only Israel will miss him

    Blundering Blair quits as Middle East peace envoy – only Israel will miss him

    For Arabs – and for Britons who lost their loved ones in his shambolic war in Iraq – his appointment was an insult, says Robert Fisk
    Fifa corruption arrests: All hail the Feds for riding to football's rescue

    Fifa corruption arrests

    All hail the Feds for riding to football's rescue, says Ian Herbert
    Isis in Syria: The Kurdish enclave still resisting the tyranny of President Assad and militant fighters

    The Kurdish enclave still resisting the tyranny of Assad and Isis

    In Syrian Kurdish cantons along the Turkish border, the progressive aims of the 2011 uprising are being enacted despite the war. Patrick Cockburn returns to Amuda
    How I survived Cambodia's Killing Fields: Acclaimed surgeon SreyRam Kuy celebrates her mother's determination to escape the US

    How I survived Cambodia's Killing Fields

    Acclaimed surgeon SreyRam Kuy celebrates her mother's determination to escape to the US
    Stephen Mangan interview: From posh buffoon to pregnant dad, the actor has quite a range

    How Stephen Mangan got his range

    Posh buffoon, hapless writer, pregnant dad - Mangan is certainly a versatile actor
    The ZX Spectrum has been crowd-funded back into play - with some 21st-century tweaks

    The ZX Spectrum is back

    The ZX Spectrum was the original - and for some players, still the best. David Crookes meets the fans who've kept the games' flames lit
    Grace of Monaco film panned: even the screenwriter pours scorn on biopic starring Nicole Kidman

    Even the screenwriter pours scorn on Grace of Monaco biopic

    The critics had a field day after last year's premiere, but the savaging goes on
    Menstrual Hygiene Day: The strange ideas people used to believe about periods

    Menstrual Hygiene Day: The strange ideas people once had about periods

    If one was missed, vomiting blood was seen as a viable alternative
    The best work perks: From free travel cards to making dreams come true (really)

    The quirks of work perks

    From free travel cards to making dreams come true (really)
    Is bridge the latest twee pastime to get hip?

    Is bridge becoming hip?

    The number of young players has trebled in the past year. Gillian Orr discovers if this old game has new tricks
    Long author-lists on research papers are threatening the academic work system

    The rise of 'hyperauthorship'

    Now that academic papers are written by thousands (yes, thousands) of contributors, it's getting hard to tell workers from shirkers
    The rise of Lego Clubs: How toys are helping children struggling with social interaction to build better relationships

    The rise of Lego Clubs

    How toys are helping children struggling with social interaction to build better relationships
    5 best running glasses

    On your marks: 5 best running glasses

    Whether you’re pounding pavements, parks or hill passes, keep your eyes protected in all weathers
    Joe Root: 'Ben Stokes gives everything – he’s rubbing off on us all'

    'Ben Stokes gives everything – he’s rubbing off on us all'

    Joe Root says the England dressing room is a happy place again – and Stokes is the catalyst
    Raif Badawi: Wife pleads for fresh EU help as Saudi blogger's health worsens

    Please save my husband

    As the health of blogger Raif Badawi worsens in prison, his wife urges EU governments to put pressure on the Saudi Arabian royal family to allow her husband to join his family in Canada