|
 By Daniel Martin and Jenny Hope
Last updated at 4:47 PM on 22nd January 2010 Tens of thousands of patients have been ordered to stop taking a popular fat-busting drug suspected of raising the risk of heart attacks and stroke.
The European Medicines Agency last night suspended the licence of the drug Reductil, which was taken by 86,000 Britons last year.
The safety watchdog fears it could threaten the health of the overweight and obese - although it says any side-effects should not be fatal.
However, some 17 deaths have been linked to the drug in Britain since 2001 - six of which were caused by heart attacks and strokes.
Some 1,105 suspected adverse reactions have been reported, a third of them serious.
Last night doctors and pharmacists were told to stop handing out Reductil.
And experts urged everyone who takes it to make an appointment with their GP to discuss alternative ways of losing weight.
It is the second popular antiobesity drug to have its licence suspended. Two years ago, the EMA suspended Acomplia over fears it could lead to suicidal thoughts.
The agency came to its decision on Reductil after examining an international clinical trial, which showed that its main ingredient - sibutramine - increases the risk of heart problems. Sibutramine tricks patients' brains into making them feel full, meaning they eat up to 20 per cent less. Last night, Dr June Raine, of the UK Medicines and Healthcare Products Regulatory Agency, said: 'Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweigh the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment.
'Prescribers are advised not to issue any new prescriptions for Reductil and to review the treatmentof patients taking the drug. Pharmacists are asked to cease dispensing the medicine.
'There are no health implications if people wish to stop treatment before seeing their doctor.'
The international trial examined by EMA followed 10,000 patients over six years. It found a 16 per cent increased risk of heart attack and stroke.
Many of those who took part in the trial had cardiovascular problems - even though one of the listed side effects of the drug is that it can raise blood pressure. The agency said that although the drug was off limits to those with heart problems, those needing it were likely to have undiagnosed cardiac conditions because of their weight.
It pointed to studies which showed that weight loss achieved with Reductil was often modest and may not be maintained after stopping. This meant the benefits did not outweigh the cardiovascular risks.
Reductil is made by Abbott Laboratories and its official side effects are listed as high blood pressure, insomnia, constipation and dry mouth.
It is prescribed to those who have made serious attempts to slim by other means, such as dieting and exercise. Treatments cost the NHS about £45 a month.
Last night, Eugene Sun of Chicago-based Abbott said: 'Many people benefit from sibutramine and we respectfully disagree with the committee's opinion and recommendation to suspend the medicine.
'However we will act promptly to comply with the committee's recommendations.'
David Haslam of the National Obesity Forum said he was surprised by the decision and knew of no study proving that Reductil had led to a death from a heart attack or stroke.
The EMA's decision leaves Orlistat as the only anti-obesity drug still freely available in the UK. Source: http://www.dailymail.co.uk/news/article-1245176/Obesity-drug-used-86-000-patients-suspended-heart-attack-fears.html |
