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A statin taken by millions of Britons may increase risk of a condition which can lead to fatal kidney failure at high doses, a drug watchdog has warned.
By Rebecca Smith, Medical Editor, 20 Mar 2010
Simvastatin is taken by around three million people in order to lower their cholesterol and reduce the risk of having a heart attack.
However an analysis of clinical trial data in America has found that high doses can cause muscle damage and a rare condition which induces kidney problems and may be fatal.
Patients were told not to stop taking simvastatin but advised to talk to their doctor if they have concerns.
The American medicines regulator, the Food and Drug Administration, has issued a warning to patients to be alert to signs of problems when taking the 80mg daily dose of simvastatin. It has also listed drugs that should not be prescribed to those on high doses of statins.
Muscle aches and damage are a known side effect of all statins but the risks are generally considered to be outweighed by the benefit in reducing the risk of a heart attack.
The FDA found that patients on the 80mg dose were more likely to develop a severe form of muscle damage called myopathy, compared with those on the lower 20mg dose.
Over six years, 52 of the 6,031 patients taking 80 mg doses developed myopathy compared with one person out of the 6,033 taking 20mg.
And 11 patients taking the 80 mg dose developed rhabdomyolysis, the most serious form of myopathy which can lead to kidney failure and death, where as none of those on the 20mg dose developed the condition.
The majority of patients in Britain taking simvastatin are on the 20mg and 40mg dose.
The FDA said patients experiencing muscle pain, tenderness or weakness, urine that is dark or red-coloured, or unexplained tiredness, should contact their doctor.
The UK drugs regulator said the side effects are known about and included in patient information with the medication.
A spokesman for the Medicines and Healthcare products Regulatory Agency said: "The 80 mg per day dose is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications.
"Myalgia (complaints of muscle aches) is a common side effect of statins, including simvastatin. It is recognised that very rarely statins can cause more serious muscle damage (myopathy) which in some cases may be life-threatening.
"There are comprehensive warnings in the product information for prescribers and in the Patient Information Leaflet.
"These warnings advise that the risk of muscle injury is greater: at higher doses of simvastatin; when used in combination with certain other medicines including amiodarone (a medicine used for an irregular heart beat) and other medicines that are recognised to increase the risk of myopathy; and in certain patient groups including those who are more than 70 years old, those with kidney or thyroid problems, those who consume large amounts of alcohol, and those with a history of previous muscle problems during treatment with statins or other lipid lowering drugs.
"As with all marketed medicines the safety of simvastatin is kept under continuous review by the MHRA."
Ellen Mason, Senior Cardiac Nurse at the British Heart Foundation (BHF) said: “Simvastatin remains a widely used and well researched drug, which has been around for many years and serious muscle damage is rare.
"It is considered a safe drug for many people in the UK to take. The benefits of statins in lowering cholesterol levels and reducing the risk of a heart attack are clear.
“Only a small number of people with very high levels of cholesterol would need to take the maximum dose of simvastatin. Any concerned patients who are taking the highest prescribed dose and experience muscle weakness or pain should speak to their GP.”
SOFT drinks with artificial sweeteners could cause kidney damage, according to new research.
By Lucy Johnston
Just two colas or sodas a day were found to double the risk of a faster-than-average decline in kidney function, scientists said. However, this problem was not linked to drinks that had been sweetened with sugar.
The researchers in the United States looked at the effect of fizzy drinks on more than 3,000 women, comparing those who consumed artificially sweetened drinks with those whose drinks were sweetened with sugar. They took into account factors such as age, high blood pressure, diabetes, smoking, and heart disease.
But the survey looked only at older white women. The scientists admitted that it was not clear whether their findings also applied to men or people of different ethnic backgrounds.
Dr Julie Lin, who co-led the survey, with a team from Brigham and Women’s Hospital in Boston, Massachusetts, said: “While more study is needed, our research suggests that higher sodium and artificially sweetened soda intake is associated with greater rate of decline in kidney function.”
The research, presented last week at the American Society of Nephrology’s annual conference in San Diego, California, was carried out as part of a major health and lifestyle investigation in the US.
A spokesman for the Beverage Association, which represents soft drink manufacturers, said it was too soon to comment on the research as it had not yet been properly evaluated by other scientists.
However, he did point out that the two main causes of chronic kidney disease were diabetes and high blood pressure “not consumption of diet soda”.
Here in Britain, the artificial sweetener aspartame is coming under more scrutiny. The government watchdog, the Food Standards Agency, is calling for volunteers to help test claims that aspartame, used in more than 4,000 products, causes illnesses.
Osmolar Phosphate Laxatives: Keeping Water in its Place
Osmolarity is a fancy word that refers to a basic rule of physics and biology and it is about how fluids - in this case it’s water – move in and out of cells based on the presence of electrolytes, most often sodium and potassium. Phosphorus and calcium are two other electrolytes that are important health and often work together.
Your body depends on a delicate balance of trace elements and enzyme reactions to keep humming like a top. When this balance is altered you run the risk of dehydration and problems with the way your kidneys work.
Simply put, when you ingest a large amount of sodium containing foods or liquids, the kidneys work to flush the excess sodium out of the body. It does this by removing fluid from inside the cells, from your tissues and organs and moves it through the kidneys or the gastrointestinal tract. This may lead to excessive urination and diarrhea. In the process you lose not only the water but your electrolyte balance is altered.
Phosphorus and calcium reactions with dehydration may lead to the formation of crystals or “stones” and reduction of kidney function.
Laxatives often become the culprit in these cases, especially for the elderly, those with heart failure, people with kidney problems, and people using prescription or over-the-counter (OTC) medication affecting kidney function (diuretics for example).
Oral Sulfur Phosphates as Preps for Screening for Colorectal Cancer
Currently colorectal cancer is the third most common cancer and it is the second leading cause of cancer related deaths, therefore screening and early detection have become an important public health issue.
Thorough bowel cleansing is an important part of preparation for this screening and it is crucial to find a product that is safe and easy use. The difficulty in getting more people to seek the screening may be increased because of concerns with the products.
One very popular laxative has been Fleet’s Phospho-Soda. The C.B. Fleet Co. of Lynchburg, VA recently, in a voluntary action, withdrew its oral, over-the-counter Fleet Phospho-Soda bowel cleansing solutions after FDA regulators warned of potential harm to the kidneys when the Phospho-Soda is used as a bowel cleanser.
While the FDA has not required a recall, Fleet also removed the EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy.
Information found urges anyone using Phospho-soda to review current FDA product information pages. They also state that it is important to follow your doctor’s guidelines and drink at least nine 8-ounce glasses of water daily to prevent dehydration.
The FDA is now moving to have these laxative products relabeled to include warnings and make them available only by prescription.
Other prescription products, Visicol and OsmoPrep, will add the new FDA required warning regarding potential kidney damage to their oral sodium phosphate products.
The concern at the FDA is that oral sodium phosphate products have been connected with kidney function problems such as acute phosphate nephropathy that can cause permanent damage and lifelong dialysis or death. In acute phosphate nephropathy, calcium-phosphate crystals deposit in the renal tubules inside each kidney.
When used as directed or at lower levels, the FDA stated there is no evidence that the OTC laxatives lead to kidney problems. The agency, however, started issuing alerts in 2006. Other data show that product lawsuits for oral sodium phosphate laxatives, including lawsuits where OSP product users developed acute phosphate nephropathy began appearing in 2003.
While Phospho-soda has been the bowel prep product used and recommended by physicians for decades, Fleet is not asking doctors to not recommend the Phospho-soda products.
Gastroenterologists and proctologists have recommended Fleet’s Phospho-soda products for years, especially in patient preparation for screening colonoscopy (a colon cancer screening examination). In a clinical trial the product achieved the highest patient acceptance scores, and cleansing was generally rated as excellent.
However, Fleet Phospho-soda should not be used in patients with congenital megacolon, bowel obstructions, ascites, congestive heart failure or kidney disease.
When problems do not exist, physicians believe the product is good because it is effective, easily tolerated by patients and affordable.
Generally most patients do not like bowel prep products. Some doctors, like Mark Wax MD, suggest the need for “virtual bowel prep”. He adds that “until that becomes an option, patients will have to undergo conventional preparation and that requires making informed decisions about available options.” Wax is associated with a company that offers virtual colonoscopy.
The company states that virtual colon screening is a minimally invasive, safe and more comfortable procedure. Recent studies have shown it to be comparable to conventional colonoscopy for finding polyps larger than one centimeter. The risk of cancer in smaller polyps is almost negligible. With virtual colonoscopy, 100% of the colon surface can be seen. It is estimated that physicians only see 70%-80% of the colon surface with conventional colonoscopy.
Should you have medical questions about using these products, contact your health care provider.
This article is part of a consumer health education series written by Gayle Eversole, DHom, PhD, MH, NP, ND, of Creating Health Institute, in collaboration with Bernstein Liebhard, LLP, who sponsors the consumer advocate website, www.ConsumerInjuryLawyers.com