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News and Opinions about MS, Health & Disability

Zinbryta use restricted in Europe after a death and four serious liver injuries

The European Medicines Agency (EMA) has restricted the use of multiple sclerosis drug Zinbryta. The agency took action after a patient died from liver injury (fulminant liver failure). The patient was in an ongoing observational study. Four cases of serious liver injury have also been reported.

We are all likely to experience some side effect of any medication we take, whether for multiple sclerosis or some other disease. Most of us, hopefully, will only have minor problems, if any, but some will be badly affected.

All medicine manufacturers provide a list of their drugs’ side effects, from major to minor, from common to rare. Pharmaceutical companies provide this information for the benefit of patients, not just healthcare professionals.

And, we need to take those lists seriously. After all, it is our health that is on the line.

I always pay close attention to news of new drugs approved for use in the treatment of MS. But, no matter how good the claimed benefits appear, I focus on the possible side effects admitted by the manufacturer.

Now, that is not to say that all disease modifying therapies (DMTs) are bad for us. But we need to balance benefits against the disadvantaged of possible side effects. Everyone must make their own decision.

Such decisions are personal. I have never accepted any DMT.

Zinbryta – liver damage risk known when approved

zinbrytaZinbryta (daclizumab) is one such DMT and its side effects include the risk of liver damage. The EU knew this when it approved the drug in July 2016. In fact, it put several measures in place to manage this risk. These included the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.

Now, though, a year later, the EMA has provisionally restricted the use of the medicine to:

  • patients with highly active relapsing remitting MS (RRMS) that has failed to respond to certain other treatment, and 
  • patients with rapidly evolving relapsing MS who cannot be treated with other medicines.

In addition, doctors must not give the medicine must to patients with liver injury.

It is not recommended for patients with autoimmune conditions other than MS. Medical professionals should be cautious when the give Zinbryta together with medicines that can damage the liver. Doctors are advised to monitor the liver function of patients to whom they give the medicine. They should closely watch patients for signs and symptoms of liver injury.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has issued these provisional recommendations as a precaution and to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

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50shadesofsun.com is the personal website of Ian Franks, a Features Writer with Medical News Today. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

 

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European Medicines Agency recommends licence for cladribine (Mavenclad)

cladribine

The European Medicines Agency has approved cladribine (brand name Mavenclad) for use with multiple sclerosis.

The agency has recommended that a licence should be granted, by the European Commission, for the treatment of highly-active relapsing MS. Cladribine is currently an anti-cancer drug under the brand names Leustat and Litak.

The next step in the process is for the European Commission to grant a licence.

As far as the UK is concerned, Cladribine will also have to be appraised by National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). These organisations decide whether the drug will be available through the National Health Service.

NICE has already started the appraisal process in anticipation of a European licence being granted. NICE could publish its decision in February 2018. If NICE approves the use of cladribine, it could be available on the NHS as early as June next year.

The medication’s development has met mixed fortunes. Russia and Australia both approved it as an MS treatment in 2010 but Europe and the United States turned it down because of safety concerns.

In 2011, a licence application was refused because of concerns about a higher risk of cancer in people taking cladribine. However, in July last year, Merck announced that further research had found that there is no such increased risk and that the EMA had accepted a new licence application.

How to take cladribine

Patients take cladribine as a pill in two treatment courses:

  • In the first course, a patient takes cladribine pills for five consecutive days in the first month and for five consecutive days in the second month
  • The second course is taken 12 months later. Again a patient takes cladribine pills for five consecutive days in the first month and for five consecutive days in the second month

Cladribine was found to reduce the risk of relapses by 58%, compared to placebo, in large clinical trials. Also, it reduces the risk of increased disability.

Clinical trials reported main side effects include reduced white blood cell counts, which in most cases was mild or moderate, and infections including herpes zoster (shingles).

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

* * * * *

50shadesofsun.com is the personal website of Ian Franks, a Features Writer with Medical News Today. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Taking care of a partner with a disability can be a labour of love

Perhaps the most overlooked people in the world of disabilities are not the people living with ds abilities but those living with them – the husband or wife who take cares of their loved one.

They are the family carers who devote so much of their lives doing all sorts of things which can include dressing them, feeding them, washing them and even assisting with toileting needs.  And a that, and more, adds up to great deal of hard work.

My beloved Lisa pushed me in my wheelchair around New York City in December 2014. Here we are at te top of the Empire State Building.

My beloved Lisa pushed me in my wheelchair around New York City in December 2014. Here we are at the top of the Empire State Building.

As I have multiple sclerosis, my loving wife Lisa is also my carer. She fastens buttons, puts on my socks, helps me to shower, makes sure I can eat the food on my plate with my one good hand, does all the housework without assistance and takes care of the garden. What’s more she pushes me around in a wheelchair.

Lisa is reluctant to be labelled as a carer, however, saying that she looks after me out of love as my wife. I am sure many husband and wife carers feel exactly the same way.

Each caring situation is unique and carers have many different needs.  They may need information about entitlements, services and individual and group support and social opportunities.  In the UK, every family carer can also undergo a Carers Assessment which could open up many opportunities for them including time out from caring, sitting services and physical help with their caring role.

By joining a carers’ support group, they can socialize with their peers and get help with their entitlements to benefits and services, breaks, education or employment.

And they can get help to access grants and benevolent funds so that they can buy items which will benefit them in their caring role.

Really important, though, carers can join a carers’ support group where they can have a chat and get a chance to meet new friends.

 

new strap

 

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To cope with serious diagnosis, grieve first

There’s no right way to grieve for the loss of anyone or anything. And that’s true for loved ones, close friends, beloved pets or even your own health when given a diagnosis of multiple sclerosis or some other disabling disease.

In all cases you are affected by grief; it is only natural. Ok, with a disease like MS that is not fatal in itself, you are not sad because of a death but soon after a neurologist gives you the news it’s natural to grieve for the healthy life you have lost.

Experts will tell you that grief is a five-stage process and I am not going to argue with them. However, it is important to realise that we are all different and that there is no right or wrong way to come to terms with a loss like this.

The five stages that I have mentioned are sometimes described slightly differently but, basically, are:

Denial: “No, that can’t be right. It’s not true.”

Anger: “The doctor took too long to diagnose it.”; “It’s (insert anyone here, even God)’s fault.”

Bargaining: “What if I had realised earlier that something was wrong?”; “What if I had gone to the doctor sooner?”; “What if I had lived a healthier lifestyle?”

Depression: “Why me? Why have I got this awful disease?”; “Why can´t I (do this or that)?”

Acceptance: “I may have this disease but I am going to live the best life that I can.”

MS_DiagnosisWhen you first find out that your symptoms and test results add up to a diagnosis of MS, it can be hard to grasp the import of the words.  Multiple sclerosis is a term you have probably heard but don’t know much about; “didn’t Mary have that? She was in a wheelchair.”

In my case, probably because I was relieved to know what was wrong, I skipped the first four stages and went straight to acceptance and then to learning more.

Talking of learning, as soon as you can, and again this is different for everyone, it’s time to find out more about MS and the good news is that there are plenty of sources of authoritative information on the internet

If you haven’t slipped into a black pool of suffering and despair, it’s now time to learn to cope with your abilities.

“Abilities? Surely I need to cope with my disabilities,” I can hear you say.

No, you don’t. You really need to focus on what you can do and how to do it. Yes, of course, remember good times from your past but accept that is now the past. It is now time to look to the present and future without fear but with planning.

For example, if you decide to move, you might want to consider choosing a bungalow or ground floor apartment; you may want to think about a level access. You might want to move to a property that has a bathroom that could be converted to a wet room.

Even if you can walk unaided now, you may want to consider moving to somewhere that could be easily adapted to enable wheelchair access. You may never need it but forward planning is best. An occupational therapist once told me that, when planning home adaptations for someone with a disability, she is not allowed to work on the current level of the person’s ability but has to think what it could be like 20 years ahead.

 

Related posts:

D-Day: MS diagnosed

‘CAN do’ attitude to life

 

 

MSNT strapline copy

 

 

 

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Mood swings and MS

 

MSNT strapline copy

 

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Being in the sun helps vitamin D levels but Orkney’s high MS rate is not due to deficiency, study shows

orkney

Spending more time in the sun can help everyone who needs to overcome his or her low level of vitamin D – and research in Scotland suggests that even taking holidays abroad may hold the key to tackling vitamin D deficiency.

People who take foreign breaks have higher levels of vitamin D in their blood, which has been linked to wide-ranging health benefits, including fighting multiple sclerosis. According to the findings, farmers also have higher levels of the vitamin – which is produced naturally in the skin after exposure to sunlight.

Researchers at the University of Edinburgh surveyed the vitamin D levels of around 2000 people in Orkney – 1 in 10 of the population – as part of the ORCADES study.

The team was interested to see whether widespread vitamin D deficiency in Orkney might explain why rates of multiple sclerosis are higher there than anywhere in the world but they were surprised to find that average vitamin D levels are higher in Orkney than mainland Scotland, with the highest levels being seen in farmers and people over 60 years of age who take regular foreign holidays.

Vitamin D is known to be associated with good bone health. It has also been linked to wide-ranging health benefits including lower blood pressure, reduced heart disease risk and better chances of surviving cancer.

Deficiency in vitamin D has been strongly linked to diseases including multiple sclerosis. Scotland has one of the world’s highest rates of MS with Orkney being the worst affected. Studies have yet to prove that vitamin D is responsible or whether it serves as a marker for how much sun exposure a person has had.

Professor Jim Wilson, who led the study at the University of Edinburgh’s Usher Institute, said: “It was surprising to see that levels of vitamin D were not worse in Orkney, and if anything they were better than in mainland Scotland. It would appear that poor vitamin D status, while common enough, cannot explain the excess of multiple sclerosis we see in Orkney.”

Emily Weiss is PhD student at the University of Edinburgh who was involved in the study. She said: “It was interesting to find that the traditional occupation of farming was associated with higher levels of vitamin D in Orkney. This may be because farmers are outside and utilising even the smallest window of vitamin D strength sunshine.

“We also found that farmers in our Orkney cohort tended to be older, suggesting that the traditional way of life is changing, leaving younger people potentially more exposed to MS risk factors such as vitamin D deficiency.”

The research is published in the journal PLoS One and was funded by the Shetland and Orkney Multiple Sclerosis Research Project.

 

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New multiple sclerosis treatment to repair myelin is at phase 2 trial stage of development

anti-lingo-1

Anti-LINGO-1 (also known as BIIB033) is a new MS treatment being development by the pharmaceutical company Biogen. It is currently being tested in people with optic neuritis, relapsing remitting MS and secondary progressive MS in phase 2 clinical trials.

LINGO is a protein found in nerve cells and myelin-making cells called oligodendrocytes. Blocking the activity of this protein with an antibody called anti-LINGO-1 has been shown to result in myelin repair in animal models of MS.

In April 2015, results from a phase 2 clinical trial testing the safety effectiveness of anti-LINGO-1 as a treatment for optic neuritis were announced at a conference. The trial involved 82 participants with a first episode of acute optic neuritis. They were given six doses of anti-LINGO-1 (100 mg per kilo weight, once every four weeks for 20 weeks) as an intravenous infusion or a placebo.

Biogen, the manufacturer, found that those taking anti-LINGO-1 had better signalling along the optic nerve, suggesting myelin repair had taken place. Participants had a 41% improvement in nerve signalling compared to the placebo group.

 While these results still need to be published in a scientific journal, these results are the first indication that a drug could promote remyelination in people.

Another phase 2 trial, also by Biogen, testing the safety and effectiveness of anti-LINGO-1 in people with relapsing remitting or secondary progressive MS began in April 2013 and is due for completion soon.

This trial involves 416 participants, who are being divided into five groups, each receiving either three, 10, 30 or 100 mg of anti-LINGO-1 per kilo weight, or a placebo, once every four weeks for 72 weeks. All participants are also receiving beta-interferon-1a injections once weekly. Researchers are investigating whether anti-LINGO-1 can improve the function of the nervous system, cognitive ability or disability over the 72-week timeframe.

Some adverse effects of MS were reported: two participants had hypersensitivity reactions to the infusion itself, while one participant had an increase in liver enzymes – which was resolved by discontinuing the treatment.

If the phase 2 trial of anti-LINGO-1 in people with MS is successful, a larger scale phase 3 trial will be carried out to confirm its effectiveness as a treatment for people with MS. Research is still at an early stage and it will be a few years before it is known whether any of these drugs are effective treatments for people with MS.

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Zika set to hit Europe but WHO plays down risk

The Aedes mosquito is the most common carrier of the Zika virus.

The Aedes mosquito is the most common carrier of the Zika virus.

Health officials are playing down the scares associated with the risk of a European outbreak of the infectious Zika virus – although they admit it is possible as the weather gets warmer.

Meanwhile, 279 pregnant women in the US and its territories have tested positive for infection with Zika. Of these, 157 are in the US and another 122 are in US territories, primarily Puerto Rico, according to the US Centers for Disease Control and Prevention (CDC).

Back in Europe, a statement from the World Health Organization (WHO) in Europe said on Wednesday, that the overall risk was ‘small to moderate’ throughout most of Europe but is highest in areas where Aedes mosquitoes thrive. These are the Portuguese island of Madeira and the north-eastern coast of the Black Sea.

“There is a risk of spread of Zika virus disease in the European Region and … this risk varies from country to country, said Zsuzsanna Jakab, the WHO’s regional director for Europe.

“We call particularly on countries at higher risk to strengthen their national capacities and prioritize the activities that will prevent a large Zika outbreak.”

The WHO’s European region covers 53 countries and a population of nearly 900 million. It stretches from the Arctic Ocean in the north to the Mediterranean Sea in the south and from the Atlantic in the west to the Pacific in the east.

An outbreak of Zika that began in Brazil has caused concern across the world. It has been linked to thousands of cases of the birth defect microcephaly where mothers became infected with Zika while pregnant.

The WHO has said there is strong scientific consensus that Zika can also cause Guillain-Barre Syndrome (GBS), a rare neurological condition that causes temporary paralysis in adults. GBS has also been linked to other neurological diseases, such as multiple sclerosis.

The WHO’s Geneva headquarters in February declared the Zika outbreak a public health emergency of international concern (PHEIC), warning it was spreading “explosively” in the Americas.

The WHO’s European office said that if no measures are taken to mitigate the threat, the presence of the Aedes aegypti mosquitoes that can carry the virus mean the likelihood of local Zika transmission is moderate in 18 countries in the region.

A further 36 European countries have low, very low or no likelihood, the assessment found. Aedes mosquitoes are not found in those countries and their climates would not be suitable for the mosquitoes to establish themselves.

Paul Hunter, a professor of health protection at Britain’s University of East Anglia, described the WHO’s Zika risk warning as ‘timely and real’ but added that any outbreak would probably be relatively short-lived.

“The risk is mostly in southern Europe and especially around the Mediterranean coast,” he said. “However, even if Zika did start to spread in Europe, it is unlikely to become established as an outbreak is very unlikely to continue over winter.”

The WHO’s European risk analysis took in multiple factors, among them the presence of Zika-transmitting mosquitoes, suitable climates for the mosquito, previous history of transmission of dengue fever or chikungunya virus, ship and flight connections, and population density and urbanization.

It also considered the capacity of the country to contain transmission at an early stage, based on four main factors: vector control, clinical surveillance, laboratory capacity and emergency risk communications.

 

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Danger of ‘silent’ heart attacks is lack of recognition

Ultrasound scan, file picture.

Ultrasound scan, file picture.

There is no doubt that heart disease is a killer. In fact, according to the World Health Organization, it is the biggest killer – and is responsible for nearly half the deaths (48.6%) of all the 10 leading causes.

Some years ago I had a heart attack although there were no obvious signs at the time. It was diagnosed later as a silent attack – the type that people suffer and do not realise they have had.

This week I learned that, as a result of new research, experts now say that 45% of people who have heart attacks suffered the ‘silent’ variety, where patients believe they have strained a muscle or have indigestion. Sometimes these may be associated with unexplained fatigue and discomfort in the jaw, upper back or arms.

Silent heart attacks can cause just as much damage as heart attacks which are instantly recognised. But as silent attacks do not come with the usual symptoms of chest or arm pain, patients do not recognise the danger and tend not to seek treatment which can help prevent another.

The research, published in the American Heart Association journal Circulation, looked at the records of 9,500 middle-aged men and women between 1987 and 2013. Nine years into the study 7.4% of the volunteers had had heart attacks; 317 were silent, while 386 noticed symptoms immediately.

Lead researcher, Dr Elsayed Soliman of the Wake Forest Baptist Medical centre, North Carolina, found the silent attacks are more common in men, but are more dangerous for women who are more likely to die from this type of attack.

Patients who have suffered a silent heart attack should be treated as if they had suffered the usual symptoms, according to Dr Soliman.

As a silent heart attack happens without the usual symptoms, such as chest pain and overwhelming anxiety, shortness of breath may be the only warning sign. But even that is not a great indicator when, like me, you already have multiple sclerosis which includes bouts of fatigue and breathlessness.

However, in 2010 even greater fatigue than usual and more frequent shortness of breath did convince me to see my GP. He diagnosed atrial fibrillation (irregular heartbeat) and referred me to a cardiologist.

There, two ultrasound scans quickly followed. At first, they thought there was a clot in the heart but doubts about that were raised by the second ultrasound – so an MRI was requested. This showed conclusively that the supposed clot was, in fact, a scar from a previous silent heart attack.

The usual ‘go to’ steps for anyone with a heart condition didn’t really apply in my case: having never smoked, being on the heavier side of ‘acceptable’ and cholesterol and blood pressure both testing as normal. Taking more exercise, however, was severely hampered by mobility problems caused by MS.

Today, even though my heart attack was silent and unknown by me, heart-related medications outnumber those taken for anything else.

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‘No further plans to cut benefits’ pledge lasts 51 days

Work and pensions secretary Stephen Crabb discloses his plans to the select committee.

Work and pensions secretary Stephen Crabb discloses his plans to the select committee.

Declaration of interest: I have multiple sclerosis and receive both ESA (in the support group) and Disabled Living Allowance (both care and mobility components at the highest rates).

 

Sneaky, very sneaky and possibly even underhanded, is the only way I can describe how the UK’s work and pensions secretary Stephen Crabb decided to reveal the government’s latest intentions to make further cuts to disability benefits.

Instead of making a statement in the House of Commons, he chose to disclose the proposals in an almost throwaway and casual style before the work and pensions committee select committee.

He told the committee that he wanted to go further than the controversial and much-criticised £12 billion welfare cuts set out in the 2015 Conservative manifesto and to ‘re-frame discussion’ around disability welfare reform.

And this, let me refresh your memory, from the same man who, after replacing Iain Duncan Smith as work and pensions secretary, announced the dumping of proposed changes to the Personal Independence Payment and said that the government had no plans to make further welfare cuts.

At the time, I warned that we should not be taken in by his ‘weasel words’.

This week Mr Crabb told the committee that he intended to set out a green paper later this year to propose further changes to disability benefits.

He explained that the measures that have either already been legislated for or announced add up to the planned £12 billion of welfare cuts but added: “Does that mean welfare reform comes to an end? I would say ‘no’. I’ve already pointed to what I see as one of the big challenges of welfare reform – and that’s around work and health.”

Mr Crabb told MPs on Work and Pensions Select Committee that he would deploy ‘smart strategies’ for cutting expenditure on disability and sickness benefits and would hopefully be able to secure the support of disability charities.

He said: “In terms of how you make progress of welfare reform there when you are talking about people who are very vulnerable, people with multiple barriers, challenges, sicknesses, disabilities – I am pretty clear in my mind that you can’t just set targets for cutting welfare expenditure,” he said.

“When you’re talking about those cohorts of people you’ve actually got to come up with some pretty smart strategies for doing it which carry the support and permission of those people and organisations who represent those people who we are talking about.

“This is why there’ll be further information in due course about this. I want to produce a green paper later this year which starts to re-frame discussion around this set of issues.”

Criticism to Crabb’s latest plans have been voiced by many including campaigning blogger Mike Sivier. Writing on Vox Political Online, he said: “He (Crabb) means he wants to cut funding to the vulnerable and make it more likely they will die, the same as Iain Duncan Smith always meant.

“This is a war of attrition; the Tories have already killed off a great many sick and disabled people and hidden the facts, in the opinion of this writer. That means there are fewer left to resist what may clearly be seen as a genocide.

“That’s why fighting these cuts is so vital. Stephen Crabb must not be allowed to think his murderous plan (whatever it is) will be easy to enact.”

Labour’s shadow work and pensions secretary Owen Smith has called on the government to dump the ESA cuts that have already been passed. He said: “The flimsy case for the cuts to Employment Support Allowance is now totally blown apart by this broken promise (that no further cuts were planned) and the Tories must listen to Labour’s calls for them to be reversed.”

 

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