Tag Archives: ban

Arthritis drug banned from sale in UK and Germany

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London: The drug Prexige (lumiracoxib), used to treat osteoarthritic pain has been suspended from sale by health regulators in the UK and Germany over liver damage fears.

Manufacturer, Novartis, is informing regulatory agencies around the world of these changes, which come after similar actions in other countries in recent months.

Novartis will also comply with a request from the Austrian health authority to suspend sales pending a final decision by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in the European Union.

Patients taking Prexige in the UK, Germany, and Austria are advised to consult their medical practitioner.

Prexige was precribed as 100 mg once-daily treatment for osteoarthritic pain following EU approval through the Mutual Recognition Procedure (MRP) in October 2006. Itis also marketed and sold in Belgium, Cyprus, Hungary, Malta, Portugal, and Sweden.

Other EU countries may decide to independently suspend the marketing authorization or sale of Prexige ahead of a decision by the CHMP, which is expected in December.

Prexige is part of a class of drugs known as a COX-2 inhibitors and liver enzyme changes are a known side effect of these and traditional non-steroidal anti-inflammatory drugs (NSAIDs).

The ban comes The actions in Europe come after an Urgent Safety Restriction was initiated in August 2007 for the Prexige 100 mg dose. Prexige was first withdrawn in August 2007 in Australia where a number of liver side effects were reported, including two deaths, associated with the use of Prexige at doses higher than 100 mg. No deaths have been reported worldwide with the 100 mg dose.

Alzheimer’s charity to fight UK government drug ban in court

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London: Alzheimer’s suffers in the UK are being denied drugs that can slow the progress of this terrible disease because the Government drug rationing body says that they are not cost effective at £2.50 a day per patient.

As a result, many patients and their families are left struggling to cope with the dreadful erosion of memory and everyday skills caused by the disease. The Alzheimer’s Society has now mounted a legal challenge to try to reverse the decision.

Around 750,000 Britons are affected by dementia – more than half of them with Alzheimer’s – at an estimated cost to the nation of £17billion a year. And as the ageing population grows the number suffering from the disease is forecast to grow to a million.

The charity The Alzheimer’s Society is mounting a legal challenge to the decision by the National Institute for Health & Clinical Excellence (NICE) in the High Court. Two of the drug companies who make the drugs, Eisai and Pfizer are leading a separate legal action on the ban.

Britons with dementia already have less access to diagnosis and treatment that those in other EU countries and the Government has no remedy for the increase in sufferers of the disease. diagnostic services and treatment options than patients in other EU countries.

Three drugs, Aricept, Exelon and Reminyl, which could slow the disease’s progress, are no longer available for patients with ‘mild’ Alzheimer’s in England and Wales although they are licensed in Scotland.

These drugs help boost low levels of a chemical within the brain which helps nerve cells to communicate, temporarily improving or stabilising symptoms in about half of patients who try them.

Only patients with ‘moderate’ symptoms are eligible for these medicines, while a new drug called Ebixa which improves severe behavioural problems can be used only as part of a clinical trial.

The scale of the problem is revealed in a Dementia UK report prepared by the London School of Economics and King’s College, London. It says the cost of £17billion each year includes NHS and social services, lost income and taxes from carers, and the estimated contribution from unpaid carers.

Delaying the onset of dementia by five years would halve the number of related deaths, saving nearly 30,000 lives annually.

Smoking ban in public places in England from next year

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London: Smoking in all public places in England will be banned from July 1 next year, the UK’s Health Secretary Patricia Hewitt has announced.

She saidsaid: “This is a triumph for public health and a huge step forward for health protection. Thousands of people’s lives will be saved and the health of thousands more protected. Smokefree legislation will protect everyone from the harm of second hand smoke when working, socialising and relaxing and will provide a more supportive environment for smokers who wish to give up.

“The scientific and medical evidence is clear – secondhand smoke kills, causing a range of serious medical conditions including lung cancer, heart disease, and sudden infant death syndrome (SIDS). This legislation will help to prevent the unnecessary deaths caused every year from secondhand smoke, and recognises that there is absolutely no safe level of exposure.

“Never has a health issue created such debate in Parliament, across government, through the business and the voluntary sectors, and amongst the general public. And the more it has been debated, the more people have responded and pushed the limits to ensure that enclosed public places and workplaces in England will become wholly smokefree.

“Where countries have gone smokefree the impact on the health of staff has been immediate and positive. And the experience of going smokefree in Ireland, Scotland, New York and elsewhere has been good for business.

“I would like to thank business groups, the leisure and hospitality industries and the many health organisations that have been involved for their support, which has helped to make this legislation a reality.

“It has been an incredible journey, but we still have a lot of work to do to support businesses to be ready for the implementation of the new laws.”

The Health Secretary also launched a new Smokefree England campaign which will help the country’s 3.7 million businesses including nearly 200,000 pubs, bars, restaurants and other leisure outlets prepare for the implementation of the legislation.

Further information:

1. With the implementation of the smokefree elements of the Health Act 2006, from 6am on the 1st July 2006, virtually all enclosed public places and workplaces will become smokefree environments. This will include offices, factories, shops, pubs, bars, restaurants, membership clubs, public transport and work vehicles that are used by more than one person. The law will also mean that indoor smoking rooms, still common in workplaces, will no longer be allowed. So anyone wishing to smoke will have to go outside instead.

2. The regulations providing the detail of how the smokefree legislation will operate are being finalised and will be laid before Parliament shortly. A copy of the Government’s proposals for regulations are available on the Department of Health’s website at:
www.dh.gov.uk

3. Information and resources to support the introduction of smokefree legislation is available on the Smokefree England website at: www.smokefreeengland.co.uk including information on how businesses and employees can access free NHS smoking cessation advice.

4. All smokefree premises and vehicles will be required to display no-smoking signs.