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
ebooks
ebookA delicious collection of 50 meaty main courses
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
SPONSORED FEATURES

ES Rentals

    Independent Dating
    and  

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

    iJobs Job Widget
    iJobs General

    Recruitment Genius: 1st Line Technical Support Engineer

    £19000 - £23000 per annum: Recruitment Genius: This IT and Telecoms company ar...

    Recruitment Genius: Assistant Manager - Visitor Fundraising

    £23000 per annum: Recruitment Genius: The Visitor Fundraising Team is responsi...

    Recruitment Genius: Developer

    £30000 - £35000 per annum: Recruitment Genius: This is an opportunity to join ...

    Recruitment Genius: Trainee Sales Account Manager - OTE £25,000

    £15000 - £25000 per annum: Recruitment Genius: Are you outgoing, ambitious, en...

    Day In a Page

    War with Isis: Is Turkey's buffer zone in Syria a matter of self-defence – or just anti-Kurd?

    Turkey's buffer zone in Syria: self-defence – or just anti-Kurd?

    Ankara accused of exacerbating racial division by allowing Turkmen minority to cross the border
    Doris Lessing: Acclaimed novelist was kept under MI5 observation for 18 years, newly released papers show

    'A subversive brothel keeper and Communist'

    Acclaimed novelist Doris Lessing was kept under MI5 observation for 18 years, newly released papers show
    Big Blue Live: BBC's Springwatch offshoot swaps back gardens for California's Monterey Bay

    BBC heads to the Californian coast

    The Big Blue Live crew is preparing for the first of three episodes on Sunday night, filming from boats, planes and an aquarium studio
    Austin Bidwell: The Victorian fraudster who shook the Bank of England with the most daring forgery the world had known

    Victorian fraudster who shook the Bank of England

    Conman Austin Bidwell. was a heartless cad who carried out the most daring forgery the world had known
    Car hacking scandal: Security designed to stop thieves hot-wiring almost every modern motor has been cracked

    Car hacking scandal

    Security designed to stop thieves hot-wiring almost every modern motor has been cracked
    10 best placemats

    Take your seat: 10 best placemats

    Protect your table and dine in style with a bold new accessory
    Ashes 2015: Alastair Cook not the only one to be caught in The Oval mindwarp

    Cook not the only one to be caught in The Oval mindwarp

    Aussie skipper Michael Clarke was lured into believing that what we witnessed at Edgbaston and Trent Bridge would continue in London, says Kevin Garside
    Can Rafael Benitez get the best out of Gareth Bale at Real Madrid?

    Can Benitez get the best out of Bale?

    Back at the club he watched as a boy, the pressure is on Benitez to find a winning blend from Real's multiple talents. As La Liga begins, Pete Jenson asks if it will be enough to stop Barcelona
    Athletics World Championships 2015: Beijing witnesses new stage in the Jessica Ennis-Hill and Katarina Johnson-Thompson heptathlon rivalry

    Beijing witnesses new stage in the Jess and Kat rivalry

    The last time the two British heptathletes competed, Ennis-Hill was on the way to Olympic gold and Johnson-Thompson was just a promising teenager. But a lot has happened in the following three years
    Jeremy Corbyn: Joining a shrewd operator desperate for power as he visits the North East

    Jeremy Corbyn interview: A shrewd operator desperate for power

    His radical anti-austerity agenda has caught the imagination of the left and politically disaffected and set a staid Labour leadership election alight
    Isis executes Palmyra antiquities chief: Defender of ancient city's past was killed for protecting its future

    Isis executes Palmyra antiquities chief

    Robert Fisk on the defender of the ancient city's past who was killed for protecting its future
    Berlusconi's world of sleaze: The astonishing lifestyle once enjoyed by Italy's former PM

    Berlusconi's world of sleaze

    The astonishing lifestyle once enjoyed by Italy's former PM
    Disney plans galactic domination with endless Star Wars spin-offs

    Disney plans galactic domination with endless Star Wars spin-offs

    Films and theme parks are just the beginning. Disney believes its control of the now decades-old franchise can bring in merchandise and marketing millions for years to come
    Could the golden age of the gaming arcade ever be revived in the era of the Xbox?

    Could gaming arcades be revived?

    The days when coin-ops were the only way to play the latest video games are gone. But a small band of enthusiasts are keeping the button-pushing dream alive
    Edinburgh Fringe 2015: The 'tampon tax' has inspired a new wave of female comedians to reclaim period jokes

    Heard the one about menstruation?

    Yes, if you have been at the Fringe, where period pieces are taking centre stage