FDA issues warning on side-effects of Statin Drugs

The Food and Drug Administration on Tuesday Feb 28, 2012 raised safety concerns about the popular class of cholesterol-fighting drugs called statins, warning that patients taking the drugs may face a "small increased risk" of higher blood sugar levels and of being diagnosed with diabetes.

The federal safety agency said Tuesday it plans to add the diabetes-risk language to the "warnings and precautions" sections of labeling for the statin drugs. The drugs that will get the warning include top-selling brand names such as Lipitor, Lescol, Pravachol, Crestor, Mevacor, Altoprev, Livalo and Zocor. Under these and a range of generic names, the drugs have been taken for years by tens of millions of people to prevent heart attack, stroke and cardiovascular disease.

The largest manufacturers of statins didn't have immediate comments on the FDA's action.

In addition, the FDA said that labels for statin drugs now will contain information about patients experiencing memory loss and confusion, though this side effect was classified as an "adverse reaction" rather than being put in the more serious warnings and precautions category.

Dr. Amy Egan, the FDA's deputy director for safety of metabolic and endocrinological products, said "these cognitive changes can be quite dramatic" and "sustained," but that they do disappear when statin therapy is stopped. She cautioned that the agency isn't able to identify a specific drug or age group of people who might be prone to such cases of memory loss and confusion, but that patients should notify their doctors if such symptoms occur.

Click here to read more from The Wall Street Journal.

Read more: http://www.foxnews.com/health/2012/02/28/fda-issues-new-warning-on-lipitor-zocor-other-statins/#ixzz1oDPfJC00

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Statins dangerously deplete CoQ10 levels

Statin drugs will slowly but surely dangerously deplete CoQ10 levels in the body, causing the heart to weaken and ultimately to congestive heart failure.

So the very drug that is supposed to protect you from heart attack and strokes actually will kill you anyway. If that's the case, why take statins in the first place?.

Simply put, the pharmaceutical industry that earns US$30 billion selling statin drugs, have so much power over governments, that they easily block safer alternatives like BiosLife from ever reaching those who want to healthily manage cholesterol, blood pressure and blood sugar levels.

Bios Life drink works 4 ways to raise your good HDL cholesterol by 29% and lower your bad LDL cholesterol by 31% within 60 days.

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Dangers of Homocystein and Triglycerides

Heart attacks and strokes can and will happen to people with normal cholesterol levels. Yet drug companies tell you you have to lower your LDL, when in fact, its actually a high HDL level that can protect you.

But they have yet to find a safe drug to increase your good HDL and another drug to reduce your Homocystein and a further drug to reduce your Triglycerides.

While doctors themselves are afraid to take Statins, due to the dangerous side effects, they will insist their patients go on Statins, as this drug prescription gives them a long term residual income.

Bioslife is the only safe, patented and clinically proven health drink to safely reduce your dangerous LDL, Homocystein and Triglycerides by 31% and raise your good HDL by 29% within 8 weeks.

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Cholesterol testing for toddlers aged 2

These drug companies have to stoop so low and now even frighten parents into testing their children as young as 2.

I think a resonable age to start testing would be early 20's, so that lifestyle changes can be done earlier and avoid the complications later on in life.

Anyway, all drugs are dangerous and have side effects, so the safest preventive thing you can do, to manage healthy cholesterol, blood pressure and blood sugar levels, is to drink your Bioslife at the earliest age you can afford it.

With Bioslife, you can enjoy a good bowel movement, have high energy levels and at the same time keep trim.

Don't let the doctors fool you, after all, the more people they have on life-long statin drugs, the more passive income they can earn, till the day you die.

Bioslife - the only clinically proven and patented statin alternative that can reduce your LDL by 31% and increase your HDL by 29% within 8 weeks, Guaranteed!.

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Your doctor earns a passive income from Statins

Ever notice how happy your doctor is to quickly recommend some life long drugs to you like high blood pressure medication, diabetes drugs or statin drugs?

Simply put, one a drug customer, always a drug customer and your doctor can start plans to buy his next holiday home, another car or a boat.

That's the reason why statin drug companies have been so successful with their 2 blocbuster statin drugs Zocor and Lipitor - with sales close to US$30 billion yearly. With 70% of their customers in the USA, you will soon see lots of cholesterol marketing coming to Asia.

What does that mean to you and me?. Well if you are in the statin alternative market with a clinically proven, patented and natural product like Bioslife, then we are in for a boom time!.

Bioslife works as well as stain drugs, except that being non chemical, there are no statin side effects like liver damage, erectile dysfunction or muscle aches.

My new Bioslife franchisor Mun Leng, recently quit her full time job, as over the last 18 days, she has earned over RM 1,500, sharing the benefits of the Bioslife product and business.

Will the Bioslife Franchise business give you a passive business icnome to offset the global food and fuel price increases?. Or make life more bearable with the subprime crisis and the 400 point Wall Street drop yesterday? Talk is cheap. Let's see!.

Statin Drugs versus BiosLife

The drugs used by doctors to treat high cholesterol are called statin medications and come with a long list of well-documented side effects. In fact, it is estimated that over 25% of the population cannot take statin medications, because of their potential side effects.

Today billions of dollars are being spent by pharmaceutical drug companies to market statin medications, illustrating the size of this market. Because of the magnitude of the heart disease epidemic, the statin medications market is expected to exceed $30 billion in sales in 2008.

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Without question Bios Life is the most effective, all-natural alternative to statin medications, for helping people reach and maintain healthy cholesterol levels. Not only is it equally effective as statins at lowering LDL (bad) cholesterol, it is also three times more effective at raising HDL (good) cholesterol.

Numerous clinical studies on Bios Life, has gained the attention of the American Heart Association who wrote a press release on Bios Life educating their members on the benefits of Bios Life. Their members—the cardiologists of the world—are facing more and more demands from their patients who do not want the potentially dangerous side effects of chemical, pharmaceutical drugs.

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Statin drugs side effects 2008 latest news

Here are links to more reputable and reliable 2008 articles by the News Media, Government and Institutions on the Side Effects of Statins and Diabetes Drugs.

FDA warns GlaxoSmithKline for not reporting safety studies of diabetes pill Avandia. Avandia received a black box warning, the most serious a drug can carry, last November. The labeling alerts doctors and patients that the drug could increase the risk of heart attacks, though the evidence is inconclusive.Sales of Avandia fell 22 percent last year to $2.4 billion for the year amid safety concerns. —– (International Herald Tribune, 8 April 2008)

Statins May Reduce Effectiveness of Rituxan® in Non-Hodgkin’s Lymphoma. Statins, or cholesterol-lowering drugs, have demonstrated anticancer activity in some patients with cancer. These drugs are being evaluated for cancer prevention and treatment for certain types of cancer. —– (Cancer Consultants, 1 April 2008)

Doctors wary after cholesterol drug flop. The study was closely watched because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. Some doctors noted that hormone pills for menopausal women and torcetrapib, a promising cholesterol drug Pfizer Inc. recently abandoned, also lowered cholesterol but were found in big studies to raise heart risks, not lower them. Many doctors have prescribed Vytorin without trying older, proven medications first, as guidelines advise.—– (Associated Press, March 30, 2008)

Drugs companies Merck and Schering-Plough ‘suppressed Ezetrol trial results’. A heavily promoted heart drug endorsed by the National Institute for Health and Clinical Excellence (NICE) may be worthless, according to a newly published trial. The new trial was designed to compare the effects of simvastatin alone with simvastatin plus Ezetrol in slowing the progression of coronary artery disease in patients with familial hyper-cholesterolaemia – a condition in which a tendency to high cholesterol levels is inherited. The result was that adding Ezetrol did nothing to slow the progress of the disease. Plaque build-up on the artery walls was the same in patients who took the combination as it was in those who took simvastatin alone. Earlier studies have shown that plaque build-up is a good proxy for death rates. The more plaque, the more deaths. So most cardiologists will conclude that prescribing Ezetrol is unlikely to prolong the lives of their patients. —– (The Times, UK, March 31, 2008)

Takeda says to drop development of cholesterol drug. The move had been expected after U.S. authorities recommended late last year that Takeda Pharmaceutical halt higher dose trials of the drug, known as TAK-475, on safety concerns, (because it couldn’t prove its effectiveness or safety advantage over existing drugs) and company executives said little to dispel worries about its development prospects.It has since filed applications with U.S. authorities seeking approval for the other two — SYR-322, which belongs to a new class of diabetes treatments, and TAK-390MR, a successor to heartburn and ulcer drug Prevacid. TAK-475 is a squalene synthase inhibitor, a type of cholesterol-lowering drug that has not yet been brought to market. Had it been approved, it would have competed against Merck & Co. Inc’s and Schering-Plough Corp’s Zetia and Vytorin. —– (Reuters, Mar 28, 2008)

Merck, Schering Call on Doctors to Boost Vytorin Use. It’s unlikely they will listen. The Vytorin combination pill, costing about $100 a month, is five times more expensive than generic simvastatin. The Enhance study was designed to persuade doctors and insurers that Vytorin is worth the extra expense. The study’s failure may be used by insurers to encourage the use of simvastatin instead. —– (Bloomberg, March 27 2008)

How to monitor statin side effects. What other drugs am I taking? - Niacin, Lopid, antibiotics, such as Biaxin? What am I drinking? - Alcohol, Grapefruit juice? Am I diabetic or more than 30 pounds above my recommended weight? —– (Daily Herald / U.S. News & World Report, 10 Mar 2008)

FDA Warns on Red Yeast Rice. Red yeast rice, a popular cholesterol-lowering dietary supplement could carry some serious health risks. The US Food and Drug Administration (FDA) has issued a warning that some brands of supplements may contain a prescription medication (known as Red Yeast Rice - lovastatin) that could be harmful to your health. Lovastatin can also cause severe muscle problems that could result in kidney damage.This risk is especially true if higher doses of lovastatin are taken or if lovastatin is combined with other medications that can also create greater susceptibility to muscle problems. Lovastatin can also interact dangerously with medications such as the antidepressant Nefazodone, certain antibiotics, drugs used to treat fungus infections, drugs used to treat HIV infections, as well as other cholesterol-lowering drugs.The FDA has ordered the makers of the red yeast rice products in question to stop marketing the supplements. Consumers are also being advised to stop taking a red yeast rice supplement if it’s one of these three types: Red Yeast Rice sold by Swanson Health Products Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., Red Yeast Rice/Policosanol Complex also sold by Swanson Health Products Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., and Cholestrix, sold by Sunburst Biorganics.—– (News Inferno, March 07, 2008)

GAO to Investigate Approval By FDA of 2 Popular Drugs. The Government Accountability Office will look into whether the Food and Drug Administration’s drug-review process cleared two popular medications without sufficient proof of their safety or effectiveness, a senator said yesterday. Sen. Charles E. Grassley (R-Iowa) requested the GAO investigation after recent studies suggested that the diabetes pill Avandia and the cholesterol drug Vytorin may not lower the risk of heart attack and artery-clogging plaque, as assumed by millions of patients and doctors. . —– (Washington Post, March 5, 2008)

Statins awful side effects. I have listened to Statin-injured people who will never be able to trust a physician again and that’s a shame because physicians are also victims of statin propaganda. The stories of real people being hurt by the drugs they are prescribed by their well-meaning physicians contain narratives too compelling to ignore. - Alan Cassels is a pharmaceutical policy researcher at the University of Victoria and a frequent commentator on prescription drug issues. —– (Common Ground, 4-Mar-2008)

Nonprescription Heart Medicine: Too Risky? “The elderly fare even worse and are more susceptible to problems” related to side-effects from statins and are less likely to take them correctly, University of Kentucky College of Medicine professor Thomas F. Whayne Jr says. “OTC statin availability to patients at high risk for adherence problems has the potential for significant harm that may remain undetected until appropriate management may be too late.” —— (UK News, 3-Mar-2008)

The Failure of Cardiovascular Medication. February is American Heart Month. It is ironic that in February of 2008 several high profile human cardiovascular drug experiments have turned into disasters for Big Pharma. These findings are sure to shake the misguided consumer confidence in drugs as a mainstay of preventive cardiovascular health. Hanging in the balance are billions of dollars of fraudulent drug sales based on the flimsy argument that changing numbers (blood sugar, cholesterol, or blood pressure) with the use of toxic drugs is somehow the same as actually being healthy. Baby boomers are the target market, a group that had no trouble rebelling in the 60s and 70s. How long will it take them this time to open their eyes to the drug-induced death march of Big Pharma? —– (American Chronicle, March 03, 2008)

Tendon complications, though rare, linked to statins. The results showed that of the 4,597 side effects associated with statins, about two percent were attributed to tendon complications. Symptoms usually occurred within 8 months of beginning statin therapy. Most patients had tendonitis, but some also suffered ruptured tendons. The most common tendon affected was the Achilles tendon, with pain, swelling, warmth, and stiffness as the most common symptoms. Seventeen of the patients had symptoms severe enough to warrant hospitalization. The researchers were able to link the tendon problems to statin use based on the fact that the symptoms appeared after the Statins were started, they improved when the statins were stopped and they recurred in all of the patients who restarted the therapy. —– (EurekAlert, 28-Feb-2008)

Alternatives to the ‘utter folly’ of statins. First there’s the tiny problem of them blocking Coenzyme Q10 (CoQ10), low tissue levels of which have indisputably been linked to heart disease. Then there’s the problem of them increasing our risk of depression, which doubles an otherwise-healthy person’s heart attack risk. Statins do effectively block cholesterol, but severely lowering cholesterol can create problems all its own. Sufficient circulating cholesterol is what keeps our cell membranes from becoming too porous, which is not exactly trivial, given that when our cells become porous our bodies release cortisol in response to what is perceived as an emergency—and high cortisol levels of course increase inflammation and damage our blood vessels. And finally, by taking hostage the most basic of tools we have for keeping high insulin levels and inflammation and obesity and heart disease at bay, Statins can have a profound muscle-weakening effect. —– (Vue Weekly, February 28, 2008)

Anti-cholesterol drugs may damage cellular power station. Certain cholesterol-reducing drugs appear to damage mitochondria, the tiny power stations inside living cells. That’s just one of several startling results uncovered by a survey that tested the biochemical effects of nearly 2500 drugs and natural products on muscle cells to assess how their mitochondria reacted to the chemicals. —– (Chemistry World, 25 February 2008)

Randone Trasylol Litigation to Be Profiled on CBS’ “60 Minutes” Trasylol is not the first dangerous and defective medication manufactured and marketed by Bayer Pharmaceuticals Corporation. Bayer also marketed the drug Baycol, a statin drug used to lower cholesterol, which was tied to more than thirty deaths before it was withdrawn from the market, and Factor 9, a blood clotting medication used by millions of hemophiliacs who developed HIV and AIDS from untested Factor 9. —– (WebWire, February 16, 2008)

Statins And Memory Loss In Women. Dr Orli Etingin, vice chairman of medicine at New York Presbyterian Hospital, and founder director of the Iris Cantor Women’s Health Center, also in New York described the effect in one patient in particular, a woman in her 40s who was unable to concentrate or remember words. They ran tests and found nothing, but when she stopped taking Lipitor, her symptoms disappeared, and when she started taking Lipitor again, they came back.—– (Medical News Today, 15 Feb 2008)

Depression Added As Possible Side Effect For Vytorin, Zetia. In letters to the drugs’ co-marketers, Schering-Plough Corp. (SGP) and Merck & Co. (MRK), the FDA said depression would be added to the section of the drugs’ package insert concerning adverse reactions in post-marketing experience. The new language also will be included in a section of the patient package inserts listing possible side effects of the drugs. Vytorin is a combination of Zetia and Simvastatin. Simvastatin is available generically and is marketed by Merck under the brand Zocor. —– (CNN Money, February 14, 2008)

‘Sensible’ assumptions put public at risk. Without proper medical research, prescription drugs can do more harm than good.….Vytorin, Zetia, Zocor, Vioxx —– (Globe and Mail Canada, February 14, 2008)

Well, Well, Well. Think of your heart this Valentine’s Day. (Statins side effects)—– (Vue Weekly, Edmonton, February 14, 2008)

The NHS has spent £74m on a new heart pill that the makers knew didn’t work. How COULD this happen? Marketed in the UK under the brand name Inegy, it contained a regular statin called simvastatin, plus ezetrol. —– (Daily Mail, 12th February 2008)

Can a (Cholesterol lowering) Drug That Helps Hearts. Be Harmful to the Brain? —– (Wall Street Journal, 12 Feb 2008)

Lowering LDL Cholesterol Without Drugs. Beyond statins, try exercise, diet, and a supplement or two. —– (US News & World Report, February 6, 2008)

Cholesterol skeptics have their day. For decades, renegade scientists have said that cholesterol-lowering drugs are ineffective for most users. Now, they say, a Big Pharma-sponsored study vindicates their claims.—– (Fortune / CNN Money, 5 Feburary 2008)

Nevada firm sues cholesterol drug makers of Vytorin and Zetia —– (CNN Money, February 04, 2008)

Schumer criticizes high cost of cholesterol drug—–(Press & Sun-Bulletin, January 31, 2008)

Researcher Admits Leaking Diabetes Study: Avandia——(NY Times / Associated Press, January 31, 2008)

Drugs reduce the wrong cholesterol —– (Blue Ridge Now, 30 January 2008)

Pharmacy professor questions Vytorin use —– (Gainesville Sun, 26 January 2008)

Will Cholesterol Pills Save Your Life? —– (New York Times, 29 January 2008)

Nexavar significantly boosts hypertension risk: study. Nexavar is a cancer drug (not a statin) but will affect your heart health —– (Reuters, 21 January 2008)

Patients raise fresh doubt over safety of cholesterol treatment —– (Camden New Journal, 19 January 2008)

Fears over drug used in Norfolk (Simvastatin) —– (Norwich Evening News, 18 January 2008)

Do Cholesterol Drugs Do Any Good? —– (Business Week, 17 January 2008)

In the Real World, a Slew of Side Effects from Statins —– (Business Week, 17 January 2008)

The Truth About Statins —– (CBS Evening News, 17 January 2008)

Study Raises Questions About Effectiveness Of Cholesterol Drugs by doctors —– (NY1 News, 15 January 2008)

Cholesterol Drugs Tied to Birth Defects —– (OnlineNews / US National Institutes of Health, 16 January 2008)

Study sees no Alzheimer’s protection from Statins —– (Reuters UK, 16 January 2008)

Study Deals Setback to Cholesterol Drug - Vytorin and its sister drug, Zetia —– (Wall Street Journal, 15 January 2008)

What you should know about Vytorin and Zetia —– (USA Today, 15 January 2008)

Statins Star Rises, But Zetia? —– (LawyersandSettlements.com. January 11, 2008)

Statin-free supplement? Not quite (Red Yeast Rice - Lovastatin) —– (Lost Angeles Times, January 14, 2008)

US Congress Probes Celebrity Drug Ad Endorsements. Lawmakers Concerned That ‘Dr.’ Jarvik Lipitor Ads May Be Misleading Viewers —– (ABC News, 10 January 2008)

SUPERDRUG’ DEATH LINK? Inquest blames cholesterol pills for psychic disturbances —– (Camden New Journal, 10 January 2008)

Lipitor doesn’t improve bone health after menopause —– (Reuters Health, January 8, 2008)

Pay careful attention to Manufacturers’ Prescription Instructions to Doctors (that are included in all statin drugs’ packaging containers) . Those listed in their Side Effects warnings on these Prescribing Instructions usually represent known side effects (if they are new drugs). When adverse drug reactions are reported from users of the drug, FDA will issue supplementary “Dear Doctor” letters and Black Box sticker warnings of adverse drug reactions (These are serious warnings to doctors by FDA indicating some patients have had life-threatening experiences taking the medication) . At this stage, the risk of the stated side effects are expected to be higher and there may be a possibility of other (unknown) side effects emerging. Your health is at risk if you continue to take such drugs after such FDA warnings had been issued. Get a second medical opinion if your regular doctor continues to ask you to take such drugs - preferably from a doctor who is more opened to alternative treatments.

Looking for a safer, natural, patented, clinically proven alternative to Statin drugs?

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Why your doctor dismisses Adverse Drug Reactions

Patients’ concerns about drug side effects are often shrugged off by their doctors, according to a survey of 650 patients who were taking cholesterol-lowering drugs known as statins.

Statins, such as Lipitor and Zocor, are common drugs with widely known side effects that include liver damage, muscle problems, memory and mood changes, and more. In the case of muscle problems, if the side effect is not recognized it can progress to a potentially fatal condition called rhabdomyolysis.

Nonetheless, patients who responded to the survey said that they had to initiate a discussion about side effects with their doctor, and when they did:

47 percent said their doctors dismissed their muscle or cognitive problems, and said they were not statin-related
51 percent with a type of nerve pain called peripheral neuropathy said their doctors denied a connection to the drugs
32 percent said their doctors denied a connection between their symptoms and statins
29 percent said their doctors "neither endorsed nor dismissed the possibility of symptom link to statins"

Rather than attributing the patients complaints to the drugs, many doctors instead blamed the “normal aging process” or denied the symptoms entirely. Aside from not addressing the health concern in the patient, this ignorance toward a potential adverse drug reaction (ADR) means that no “adverse event report” is being given to the U.S. Food and Drug Administration (FDA).

Side effects are already underreported by 90 to 99 percent, according to one Harvard Medical School expert, and the FDA relies heavily on such reports to gauge a drug’s safety once it hits the market.

In short, the survey suggests that the FDA is missing out on a wealth of ADRs because doctors are not recognizing them in patients.

The study’s authors believe that statin-related side effects are not the only one’s being missed.

They suggest that many other drug side effects are also being ignored. The researchers speculated that doctors’ tendencies to ignore drug side effects may be due to the powerful ad campaigns touting medications’ benefits and downplaying side effects.