Diabetes drug Avandia banned in Europe, restricted in US

The diabetes drug Avandia will no longer be available to patients in Europe and will be restricted in the US over fears it increases the risk of heart attack and strokes, regulators said Thursday.

The controversial drug made by British company GlaxoSmithKline would be pulled in Europe within the next few months, said the European Medicines Agency.

In the United States, the Food and Drug Administration decided to severely limit the availability of Avandia but stopped short of an outright ban.

It cited data that suggested "an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated" with the drug, which has long been associated with such health problems.

GlaxoSmithKline said it believed Avandia - which generated some 1.2 billion dollars in 2009 for the firm - remained an "important treatment" and was working with the regulators to resolve the concerns.

The European watchdog said it had taken the decision to pull the drug due to concerns over its active substance rosiglitazone.

It decided also to halt the sale of Glaxo's other diabetes drugs, Avandamet and Avaglim, since they too contained rosiglitazone.

"The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim," said a statement from the EMA.

"These medicines will stop being available in Europe within the next few months. Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments."

The EMA said the Europe-wide suspension would remain unless there was "convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks".

US regulator the FDA had already slapped a health warning on the drug after a study in 2007 linking the medication to serious health concerns.

Under the FDA's restrictions announced Thursday, Avandia will be available to new US patients with type 2 diabetes only if they are unable to control their glucose levels through other medications.

Existing diabetes sufferers taking Avandia will be allowed to continue to take the medicine if they so choose, the FDA statement said.

Doctors will now have to attest that their patients are eligible to be prescribed Avandia, and the patients will have to acknowledge that they are aware of the risks.

"The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks," said FDA commissioner Margaret Hamburg.

"We are seeking to strike the right balance to support clinical care."

The FDA said it would require Glaxo to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy.

 

PROMOTED VIDEO
Life and Style
ebooksA superb mix of recipes serving up the freshest of local produce in a delicious range of styles
Life and Style
ebooksFrom the lifespan of a slug to the distance to the Sun: answers to 500 questions from readers
Extras
indybest
Arts and Entertainment
Judi Dench appeared at the Hay Festival to perform excerpts from Shakespearean plays
tvJudi Dench and Hugh Bonneville join Benedict Cumberbatch in BBC Shakespeare adaptations
Arts and Entertainment
Exhibition at the Centre Pompidou in Metz - 23 May 2012
art
Sport
Is this how Mario Balotelli will cruise into Liverpool?
football
News
Ronahi Serhat, a PKK fighter, in the Qandil Mountains in Iraqi Kurdistan
i100
Arts and Entertainment
Alfred Molina, left, and John Lithgow in a scene from 'Love Is Strange'
film
Independent
Travel Shop
the manor
Up to 70% off luxury travel
on city breaks Find out more
santorini
Up to 70% off luxury travel
on chic beach resorts Find out more
sardina foodie
Up to 70% off luxury travel
on country retreats Find out more
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

    Soft Developer (4.0, C#, Windows Services, Sockets, LINQ, WCF)

    £65000 - £75000 per annum: Harrington Starr: .NET Developer (4.0, C#, Windows ...

    C# Developer -Winforms, VB6 - Trading Systems - Woking

    £1 per annum: Harrington Starr: A leading financial software house with its He...

    C #Programmer (.Net 4.0/4.5/ C#) -Hertfordshire-Finance

    £45000 - £50000 per annum: Harrington Starr: C #Developer (.Net 4.0/4.5/ C#, A...

    JQuery Developer JQuery, UI, Tomcat, Java - Woking

    £1 per annum: Harrington Starr: JQuery Developer JQuery, UI, Tomcat, Java - Tr...

    Day In a Page

    Middle East crisis: We know all too much about the cruelty of Isis – but all too little about who they are

    We know all too much about the cruelty of Isis – but all too little about who they are

    Now Obama has seen the next US reporter to be threatened with beheading, will he blink, asks Robert Fisk
    Neanderthals lived alongside humans for centuries, latest study shows

    Final resting place of our Neanderthal neighbours revealed

    Bones dated to 40,000 years ago show species may have died out in Belgium species co-existed
    Scottish independence: The new Scots who hold fate of the UK in their hands

    The new Scots who hold fate of the UK in their hands

    Scotland’s immigrants are as passionate about the future of their adopted nation as anyone else
    Britain's ugliest buildings: Which monstrosities should be nominated for the Dead Prize?

    Blight club: Britain's ugliest buildings

    Following the architect Cameron Sinclair's introduction of the Dead Prize, an award for ugly buildings, John Rentoul reflects on some of the biggest blots on the UK landscape
    eBay's enduring appeal: Online auction site is still the UK's most popular e-commerce retailer

    eBay's enduring appeal

    The online auction site is still the UK's most popular e-commerce site
    Culture Minister Ed Vaizey: ‘lack of ethnic minority and black faces on TV is weird’

    'Lack of ethnic minority and black faces on TV is weird'

    Culture Minister Ed Vaizey calls for immediate action to address the problem
    Artist Olafur Eliasson's latest large-scale works are inspired by the paintings of JMW Turner

    Magic circles: Artist Olafur Eliasson

    Eliasson's works will go alongside a new exhibition of JMW Turner at Tate Britain. He tells Jay Merrick why the paintings of his hero are ripe for reinvention
    Josephine Dickinson: 'A cochlear implant helped me to discover a new world of sound'

    Josephine Dickinson: 'How I discovered a new world of sound'

    After going deaf as a child, musician and poet Josephine Dickinson made do with a hearing aid for five decades. Then she had a cochlear implant - and everything changed
    Greggs Google fail: Was the bakery's response to its logo mishap a stroke of marketing genius?

    Greggs gives lesson in crisis management

    After a mishap with their logo, high street staple Greggs went viral this week. But, as Simon Usborne discovers, their social media response was anything but half baked
    Matthew McConaughey has been singing the praises of bumbags (shame he doesn't know how to wear one)

    Matthew McConaughey sings the praises of bumbags

    Shame he doesn't know how to wear one. Harriet Walker explains the dos and don'ts of fanny packs
    7 best quadcopters and drones

    Flying fun: 7 best quadcopters and drones

    From state of the art devices with stabilised cameras to mini gadgets that can soar around the home, we take some flying objects for a spin
    Joey Barton: ‘I’ve been guilty of getting a bit irate’

    Joey Barton: ‘I’ve been guilty of getting a bit irate’

    The midfielder returned to the Premier League after two years last weekend. The controversial character had much to discuss after his first game back
    Andy Murray: I quit while I’m ahead too often

    Andy Murray: I quit while I’m ahead too often

    British No 1 knows his consistency as well as his fitness needs working on as he prepares for the US Open after a ‘very, very up and down’ year
    Ferguson: In the heartlands of America, a descent into madness

    A descent into madness in America's heartlands

    David Usborne arrived in Ferguson, Missouri to be greeted by a scene more redolent of Gaza and Afghanistan
    BBC’s filming of raid at Sir Cliff’s home ‘may be result of corruption’

    BBC faces corruption allegation over its Sir Cliff police raid coverage

    Reporter’s relationship with police under scrutiny as DG is summoned by MPs to explain extensive live broadcast of swoop on singer’s home