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Sunday, March 21, 2010

Another Statin Warning

UPDATE: 22 March -  "...demonstrated mitochondrial mechanisms for muscle AEs have implications to other nonmuscle AEs in patients treated with statins. In meta-analyses of randomized controlled trials (RCTs), muscle AEs are more frequent with statins than with placebo. A number of manifestations of muscle AEs have been reported, with rhabdomyolysis the most feared. AEs are dose dependent, and risk is amplified by drug interactions that functionally increase statin potency, often through inhibition of the cytochrome P450 3A4 system. An array of additional risk factors for statin AEs are those that amplify (or reflect) mitochondrial or metabolic vulnerability, such as metabolic syndrome factors, thyroid disease, and genetic mutations linked to mitochondrial dysfunction. Converging evidence supports a mitochondrial foundation for muscle AEs associated with statins, and both theoretical and empirical considerations suggest that mitochondrial dysfunction may also underlie many nonmuscle statin AEs. Evidence from RCTs and studies of other designs indicates existence of additional statin-associated AEs, such as cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction. Physician awareness of statin AEs is reportedly low even for the AEs most widely reported by patients. Awareness and vigilance for AEs should be maintained to enable informed treatment decisions, treatment modification if appropriate, improved quality of patient care, and reduced patient morbidity." Copyright 2008 Adis Data Information BV

For those who do not understand, the health warnings on statin drugs were well known before they were marketed.

Statins do cause risk of heart attack, statins do cause risk of kidney failure, statins do deplete several key heart and health nutrients, muscle cell wasting is a known problem related to kidney failure, many other issues have been identified.

Diagnosis should be more targeted before you take these drugs, especially a proper evaluation of thyroid function (which is much more than a TSH).

Our Health Detective program can help you if you are concerned about this drug and its many problems. We also have many options for safe and natural lowering of triglycerides and increasing HDL.

Here's a new report -
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.”


PDM said...

Of course the FDA recently expanded the indication of another drug in the same class, Crestor, to include people with normal cholesterol! It isn't like the FDA hadn't already issued a Public Health Advisory about Crestor and rhadomyolysis

Are we looking at another tragedy unfolding and yet another embarrassing about face by a compromised regulatory agency. Meanwhile the "lipid hypothesis" itself is being more and more widely questioned after decades of intensive lipid lowering have had no effect on heart disease rates. Perhaps even more astonishingly, when Dr. Uffe Ravnskov, MD PhD reviewed the medical literature he found something quite surprising had been documented there. On average, at least according to Dr. Ravnskov's review of the literature, people with higher cholesterol live longer. You can read on this here if interested.

There is also a write-up about Dr. Duane Graveline, MD and former NASA astronaut's findings concerning statins and the rare but serious side effect of global transient amnesia.

Wonder if this new FDA advisory will change prescribing patterns? Or will the Zocor indication just be expanded to healthy people with normal cholesterol?

Unknown said...

Thank you for your comments. I have been following Ravnskov and Graveline for many years and their references are found on my main domain,

drarvay said...

An Appeal for Support and Conformation of MRI Results

My daughter has lived with ALS-like symptoms for almost 3 years. The worst of the symptoms began when her simvastatin was increased to 80mg in 2008.
Her MRIs show LESIONS in the brain stem, specifically in the PONS area of her brain.
Of course, her 4 physicians refuse to believe that a statin is involved. They are all satisfied with the diagnosis of “Ataxia”.

My Appeal is to all those who are/were on statins and have similar brain lesions as shown and documented in MRIs. Please reply here, or contact her father directly: Dr Stephen Arvay,