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THE MANUFACTURERS OF a drug for multiple sclerosis have withdrawn the medicine from the market, following reports of serious side effects.
Zinbryta, or daclizumab, was approved for reimbursement by the HSE last year, and had been shown to reduce the frequency of relapses and the progression of multiple sclerosis in clinical trials, one of which involved patients at St Vincent’s University Hospital and Beaumont Hospital – both in Dublin.
MS Ireland advised patients taking the drug to “please contact your neurologist to find out about alternative treatment options”, as the drug has been immediately pulled off the market.
The European Medicines Agency (EMA) yesterday recommended the immediate suspension and recall of Zinbryta following 12 reports of “serious inflammatory brain disorders” worldwide, including encephalitis and meningoencephalitis. Three of the cases were fatal.
Ireland’s Health Products Regulatory Authority, citing the EMA’s advice, said that measures to protect patients’ health were necessary given the reports of the severe reactions among a number of patients.
The EMA advised patients to:
Biogen and Abbvie, the companies that make the drug, had already said it would be voluntarily recalling the medicine worldwide, as “patient safety is the top priority”.
It said in a statement: “The companies believe that characterising the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated.”
MS is a disease of the central nervous system that affects around 9,000 people in Ireland. In MS, the body’s immune system causes inflammation, which damages the protecting coating around the nerves in the central nervous system, stopping the nerves from working properly.
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fantastic tournament, well played luca.
Best tournament in years. Brecel and si were unreal
Thoroughly deserved the win
Fantastic Final …. and Mark Selby’s 147 yesterday was brilliant, Well done Luca enjoy your year !!!
Luca an Si the two hero’s of the tournament
Amazing, credit to Shelby, what a warrior. Luca could go on to win many world titles…. Though he could just disappear into the night.
Snooker final a brilliant sporting event to watch, always brings drama. What a match well done Luca fully deserved.
Brilliant final. Well done Luca You deserve it
@all devices: exactly, some people say ‘cos there’s no physical contact, it’s not a real sport, but u need a lot of skill and mental toughness to make the grade. Is it a sport or a game, who cares, I love it. Well done Belgian Bullet.
To those so called (snob) sports commentators who constantly run down snooker as a sport, F youuuu..!
Great tournament. There’s a particular ‘sports’ show on radio which regularly states that unless you have to to change your shoes to participate ‘its not a sport’.
Weii done
Surprise winner.
have your say