Pfizer pulls Thelin from market due to fatal risk

US pharmaceutical giant Pfizer announced on Friday it is pulling its blood pressure drug Thelin off the market due to a potentially life-threatening risk of liver damage.

Pfizer said it was voluntarily withdrawing Thelin in the European Union, Canada and Australia and is also suspending all clinical tests on the drug that treats pulmonary arterial hypertension (PAH), a rare, incurable disease that can result in heart failure and early death.

"While liver toxicity is a known complication of the class of drugs to which Thelin belongs, a new potentially life-threatening idiosyncratic risk of liver injury with Thelin has been observed," Pfizer said in a statement.

"Given the availability of alternate treatments, Pfizer has concluded that the overall benefit of Thelin no longer outweighs the risk in the general population of PAH patients."

The company said it had notified health authorities about its findings and its decision to withdraw Thelin from the market and stop clinical studies.

"Patients taking Thelin or participating in Thelin studies are advised to consult with their health care professional as soon as possible," it said.

It added that patients should not stop taking Thelin until they speak with their doctor.

The European Medicines Agency (EMA) said it had been informed of the move and would discuss the issue at its meeting next week.

Pfizer acquired the rights to Thelin - an oral, once-daily drug - when it took over Encysive Pharmaceuticals in 2008 in a 195-million-dollar deal.

Thelin had yet to be approved by the US Food and Drug Administration, which said it was not sufficiently effective.

PAH is estimated to affect 100,000 to 200,000 people in North America and Europe, including about 55,000 in the United States.

Though rare, the disease affects men and women of all races and ages, but is more common among women aged 20 through 40. The disease may be misdiagnosed as asthma, anemia or chronic obstructive pulmonary disease.

PAH is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs.

The pulmonary arteries become thickened and constricted, forcing the heart to work harder to pump blood through the lungs, leading to fatigue and eventually to heart failure.

Thelin acts to dilate the constricted blood vessels, thereby reducing pulmonary arterial pressure and improving the heart's performance.

Thelin sales reached 44.4 million dollars in the first nine months of this year, according to Pfizer spokesman Allen Curtis.

The news did little to Pfizer's shares, which were virtually unchanged on Wall Street at 1530 GMT.

rb/jk

 

Life and Style
ebookNow available in paperback
Life and Style
tech
Arts and Entertainment
Rocky road: Dwayne Johnson and Carla Gugino play an estranged husband and wife in 'San Andreas'
filmReview: In the face of all-round devastation, even Dwayne 'The Rock' Johnson appears a little puny
News
i100
Arts and Entertainment
Bright lights, big city: Melrose Avenue in Los Angeles by dusk
books
Sport
Harry Kane makes Paul Scholes' Premier League team of the season
footballPaul Scholes on the best players, managers and goals of the season - and the biggest disappointments
News
i100
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

    Fifa corruption: The 161-page dossier that exposes the organisation's dark heart

    The 161-page dossier that exposes Fifa's dark heart

    How did a group of corrupt officials turn football’s governing body into what was, in essence, a criminal enterprise? Chris Green and David Connett reveal all
    Mediterranean migrant crisis: 'If Europe thinks bombing boats will stop smuggling, it will not. We will defend ourselves,' says Tripoli PM

    Exclusive interview with Tripoli PM Khalifa al-Ghweil

    'If Europe thinks bombing boats will stop smuggling, it will not. We will defend ourselves'
    Raymond Chandler's Los Angeles: How the author foretold the Californian water crisis

    Raymond Chandler's Los Angeles

    How the author foretold the Californian water crisis
    Chinese artist who posted funny image of President Xi Jinping facing five years in prison as authorities crackdown on dissent in the arts

    Art attack

    Chinese artist who posted funny image of President Xi Jinping facing five years in prison
    Marc Jacobs is putting Cher in the limelight as the face of his latest campaign

    Cher is the new face of Marc Jacobs

    Alexander Fury explains why designers are turning to august stars to front their lines
    Parents of six-year-old who beat leukaemia plan to climb Ben Nevis for cancer charity

    'I'm climbing Ben Nevis for my daughter'

    Karen Attwood's young daughter Yasmin beat cancer. Now her family is about to take on a new challenge - scaling Ben Nevis to help other children
    10 best wedding gift ideas

    It's that time of year again... 10 best wedding gift ideas

    Forget that fancy toaster, we've gone off-list to find memorable gifts that will last a lifetime
    Paul Scholes column: With the Premier League over for another year, here are my end of season awards

    Paul Scholes column

    With the Premier League over for another year, here are my end of season awards
    Heysel disaster 30th anniversary: Liverpool have seen too much tragedy to forget fateful day in Belgium

    Liverpool have seen too much tragedy to forget Heysel

    Thirty years ago, 39 fans waiting to watch a European Cup final died as a result of a fatal cocktail of circumstances. Ian Herbert looks at how a club dealt with this tragedy
    Amir Khan vs Chris Algieri: Khan’s audition for Floyd Mayweather may turn into a no-win situation, says Frank Warren

    Khan’s audition for Mayweather may turn into a no-win situation

    The Bolton fighter could be damned if he dazzles and damned if he doesn’t against Algieri, the man last seen being decked six times by Pacquiao, says Frank Warren
    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