New info about statin safety affects millions

<p><br />U.S. Food and Drug Administration issued new safety information about these cholesterol-lowering drugs that are prescribed to millions of Americans to lower the risk of heart disease. If you're among them, you should understand what the FDA's new guidance means for your health. "Before anyone gets too concerned, you should know that statins are so widely used because they have a long track record of safety and effectiveness," says Dr. Mark Taber, a cardiologist with SSM Heart Institute at St. Joseph Health Center. "All in all, statins have a very high benefit to risk ratio. The widespread use of the drugs, when indicated, probably accounts to a significant degree for the improvement in life expectancy in this country." The FDA called attention to the threat of liver damage as a rare side effect of statins and advised that regular liver enzyme testing is no longer considered useful in predicting or preventing liver injury. "Actually, in general they liberalized the follow up needed for liver function tests on patients taking statins, due to the very low incidence of true liver issues," Taber says. The main warnings related to a slightly higher incidence of developing diabetes while on statins, and a poorly substantiated claim that statins could result in cognitive impairment. Taber points out that cognitive problems, such as confusion or memory problems, were not documented in clinical studies, only by patient reports to the FDA website. "By stating these concerns, the FDA is raising awareness about the potential side effects of statins, but cardiologists already know that there are inherent risks, and we monitor patients appropriately to help ensure that side effects do not occur or are dealt with quickly," Taber notes. "If there is any evidence of a side effect that could be problematic, we can change the medication. But the fact remains that it's important to decrease risk of heart disease, and for many people statins are needed when diet and exercise alone don't result in acceptable cholesterol levels." Whenever a new prescription medication is started, you should look over the package insert to learn about potential side effects. Signs of liver damage, for instance, include fatigue, loss of appetite, right upper abdominal pain, dark urine and jaundice. Any of these symptoms should be reported to your doctor for evaluation. It is important to remember that you should not stop taking a medication without consulting your doctor first. Discontinuing use of a prescribed drug can be far more dangerous than the side effect you're worried about. "All the side effects listed by the FDA are rare, and the risk of heart attack is far more concerning," Taber says. "Some patients may need extra monitoring or may need to try more than one statin before we find the optimal choice, but in general statins are very well tolerated and don't cause problems for the people who take them." The advice above is universal when it comes to your health. Concerns should be discussed with your doctor, and decisions should always be made as part of a team approach to creating a healthy life.</p>

New info about statin safety affects millions

U.S. Food and Drug Administration issued new safety information about these cholesterol-lowering drugs that are prescribed to millions of Am...

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Why don't GPS warn you that statins can harm your memory?

<p><br />John Holliday had been on a higher 40mg dose of cholesterol pills for only a few weeks when he started to lose his concentration. ‘I’d be watching TV and suddenly find myself unable to follow the plot of a drama,’ says John, 52, a telecoms project manager who lives in Southend-on-Sea, Essex, with his wife Jill, 51, and their two children Adam, 20, and Emma, 16. ‘I’d have to read the same page of a book over and over because I couldn’t take any information in. ‘I’d always been known for my amazing memory — I was great on trivia and had total recall of events that happened 20 years ago, but suddenly I couldn’t remember things and my brain felt fuzzy.’ Just like up to seven million other people in Britain, John had been prescribed a statin to lower his blood cholesterol levels. The drugs are credited by the British Heart Foundation as contributing towards the dramatic 50 per cent fall in deaths from heart attacks in the past ten years. But while there is consensus that statins are lifesavers for people who have previously had a heart attack, concern is growing over their debilitating side-effects. They include muscle weakness, depression, sleep disturbance, sexual dysfunction, muscle pain and damage, gastro-intestinal problems, headaches, joint pains and nausea. Now, official bodies here and in the U.S. have ordered that the drugs must carry warnings for cognitive problems, too. Worryingly, it’s claimed GPs are failing to warn patients of the effect statins can have on the mind — meaning they may mistake them for signs of ageing or Alzheimer’s. ‘When I went back to my doctor after six weeks for a blood test, I told him how dreadful I was feeling,’ says John. ‘But he just said all drugs had side-effects and didn’t mention reducing the dose.’ It's claimed GPs are failing to warn patients of the effect statins can have on the mind - meaning they may mistake them for signs of ageing or Alzheimer's Things came to a head when a friend showed John an electrical circuit he’d built for his car. ‘I’d worked with circuits since I was 16 but it made no sense,’ he says. So John insisted on seeing his doctor again and repeated his concerns about his rapidly declining memory. This time the GP told him he could start on another type of statin when he felt well enough, and so John stopped taking the drugs immediately. ‘It took a few months, but gradually my memory returned and I’ve got my concentration back. I can’t say for sure statins caused these problems, but it seems like too much of a coincidence.’ Earlier this year, the Food and Drug Administration (FDA) in the U.S. ordered statins must carry warnings that some users have reported cognitive problems including memory loss, forgetfulness and confusion. This followed a decision by the UK’s Medicines Healthcare Regulatory Agency (MHRA) to add memory problems to the list of  possible statin side-effects in late 2009. The FDA said reports about the symptoms were from across all statin products and age groups. Those affected reported feeling fuzzy or unfocused in their thought process — though these were found to be rare and reversible. The FDA also warned, following U.S. research, that patients on statins had a small excess risk of developing Type 2 diabetes — but stressed that the benefits of taking a statin still outweigh this. The MHRA had 2,675 reports for adverse drug reactions connected with statins between 2007 and 2011. Officially, side-effects are rare —affecting only 1 per cent of people on the pills — but some doctors say they are under-reported. Dr Malcolm Kendrick, a GP and author of The Great Cholesterol Con, says he frequently sees patients suffering from mental confusion in his job in hospital intermediary care for the elderly. ‘Many of the patients I see will have been admitted to hospital after a fall or similar crisis,’ he says. ‘If they appear confused I’ll often advise taking them off statins to see if it has any effect — in my experience, about 10 to 15 per cent of people who appeared to have memory problems experienced an improvement in their memory symptoms after being taken off the drug. ‘I had one dramatic case where a lady was admitted to hospital on 40mg a day of simvastatin with such poor memory function her family asked me about power of attorney. 'I suggested taking her off statins and within a week her memory had returned to normal. She went home a fit and independent 83-year-old.’ Dr Kendrick says cholesterol is the main constituent of synapses (structures that allow signals to pass between brain cells and to create new memories) and is essential for brain function. ‘It is still not proven that statins have a significant effect on mortality — it has been calculated that a man who has had a heart attack who took a statin for five years would extend his life by only 14 days. 'Too many statins are being given to people at low risk. ‘Even in the highest risk group you need to treat 200 people a year with statins to delay just one death. 'One day the harm these drugs are doing is going to be obvious — the benefits are being over-hyped and the risks swept under the carpet.’ While Dr Kendrick’s controversial view is in the minority, one large review of 14 studies by the London School of Hygiene and Tropical Medicine, published by the highly respected Cochrane Library last year, concluded there was ‘little evidence’ cholesterol-lowering drugs protect people who are not at risk of heart disease. This review has been criticised by other doctors who say side-effects are rare and that there are still benefits even for people at lower risk who do not have established heart disease. These defenders of statins include Professor Colin Baigent of the Clinical Trial Service at Oxford University, who published research in 2010 showing statins reduced deaths from all causes by 10 per cent over five years. ‘There is relatively little evidence of cognitive impairment — what evidence there is all comes from observational studies.  ‘People read about side-effects and then put two and two together and blame the statins for their muscle pain or other health problems — it’s just not reliable evidence. ‘If you look at the best-quality randomised controlled trial where patients don’t know if they are taking a statin or placebo, there is no evidence of memory problems. 'Even the FDA says the risks of cognitive problems are very small and go away when statins are discontinued. ‘We’re in danger of forgetting just how effective these drugs are.’ Dr Dermot Neely of the charity Heart UK, and lead consultant at the Lipid and Metabolic Clinic at the Royal Victoria Infirmary in Newcastle, agrees side-effects with statins are rare. ‘I’ve been dealing with patients on statins since 1987 and I can count on the fingers of one hand the number whose memory symptoms turned out to be caused by statins.’ However, he said he often saw patients who had not been told about side-effects. ‘It’s important GPs are clear about the drugs statins can interact with, such as certain antibiotics, as this can get overlooked. ‘If a patient notices an adverse effect after starting statins, they should discuss this with their GP —but not stop their drugs suddenly because this can be dangerous.’ Sonya Porter, 73, decided to stop taking statins after her memory problems became so bad that she walked away from a cashpoint leaving her money behind. ‘I was permanently fuzzy-headed and just couldn’t seem to concentrate,’ says Sonya, a retired PA from Woking, Surrey. Then I started to get scared I might have Alzheimer’s. After reading about memory problems associated with statins, I thought it was at least a possibility. I decided to come off the pills to see if it made any difference. ‘I didn’t ask my GP, I just did it — I’d rather die of a heart attack than Alzheimer’s disease. Within a month I felt normal again and didn’t have any problems with memory. ‘I’m terrified that I could have been misdiagnosed with Alzheimer’s.’ John Holliday is also reluctant to go back on statins. ‘I wouldn’t rule it out completely — my latest test showed my cholesterol levels have gone up,’ he says. ‘But on balance, I’d rather take my chances with heart disease than feel as confused as that again. It’s all very well living slightly longer — but it’s about quality of life, too.’</p>

Why don't GPS warn you that statins can harm your memory?

John Holliday had been on a higher 40mg dose of cholesterol pills for only a few weeks when he started to lose his concentration. ‘I’d be w...

Read more »