On June 8, 2011 the U.S. Food and Drug Administration (FDA) called for a new label warning on the popular Cholesterol lowering drug Zocor (Simvastatin) because of an increased risk of muscle damage, kidney failure and death.The highest risk has been seen among some people taking 80mg of Zocor daily, particularly during the first year of treatment.
New FDA Recommendations for Zocor (Simvastatin)
1) Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).
2) Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.
3) When used with Simvastatin, several medications can raise the levels of Simvastatin in the body and increase the risk of myopathy. Taking no more than the recommended dose of Simvastatin with these medications will help keep Simvastatin levels in the body at a safer level. Click here for the list.
In addition to being sold as a single medication, Simvastatin is combined with Ezetimibe and sold as Vytorin and also combined with niacin and sold as Simcor. According to the FDA, “It is estimated that approximately 2.1 million patients in the U.S. were prescribed a product containing 80-mg simvastatin in year 2010.”
“What’s scary about Simvastatin,” according to Matthew Herper’s June 9, 2011, article in Forbes magazine, “is the fact that Simvastatin was approved in 1991. This drug has been on the market for 20 years and despite the tone of much of the coverage, this is not a medicine only taken by a few people.”
The FDA is not only extremely late in its warning, but it is dangerously underestimating the number of people at risk because they said that only 2.1 million people had been prescribed the 80 milligram dose, either by itself or in a combination pill like Vytorin or Simcor last year, when prescription data from IMS Health shows that various forms of Simvastatin were prescribed 100 million times last year and the 80 mg dose of Simvastatin and Vytorin were prescribed 11.3 million and 1 million times, respectively.”
Why is Simvastatin Not Being Recalled?
The simple answer is money. Simvastatin was first approved in 1991. By 1995, Zocor had been prescribed for 3.1 million patients worldwide with nearly 1 million of those patients being Americans. Zocor recorded sales of $700 million in 1992 and $900 million in 1993.
According to a January, 2006 article published at CNN Money.com, “sales for Zocor totaled $3.3 billion during the first nine months of 2005. The company has projected total Zocor sales of $4.2 billion to $4.5 billion in 2005. This is down from the 2004 tally of $5.2 billion.
Zocor’s patent protection ran out in June 2006. Merck can still make and sell Zocor after patent loss, but it would no longer factor as a key driver to corporate sales. After a branded drug loses protection, the price typically plunges about 40 percent during the first six months, followed by another 40 percent plunge after that.”
A drug patent lasts 20 years. Why didn’t the FDA know it was killing people 20 years ago? The answer: they weren’t looking for side-effects then. Now that the patent has run out and nearly 100 million prescriptions are being written each year for Simvastatin they appear to be covering up the harm being done by all statin drugs by minimizing the numbers.
The newest data comes from the FDA’s review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency’s March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Apparently the data are now too obvious to be ignored, so they simply minimize the harm done by downplaying the numbers of people that are at risk.
The FDA admits that Rhabdomyolysis can damage muscles as well as the kidneys and lead to kidney failure and death. In the past, the FDA used to recall and ban every drug that killed people. Now, however, they arrogantly announce that a few deaths are worth the benefits of the drug, but never tell you just how many deaths are occurring. Instead they play a game with the numbers. They merely state something like the following: “hospitalized rhabdomyolysis occurs in 4.9 people out of every 100,000 people exposed to simvastatin for one full year.” (FDA Drug Safety Communication; June 8, 2010)
The truth is that there were 94.3 million prescriptions for Simvastatin filled in 2010. Based on the 4.9 cases of hospitalized Rhabdomyolysis per 100,000 prescriptions, that means that 4900 people were hospitalized in 2010 and many of them died. The FDA does not want to publish data on how many died. However, Other investigators have found that at least 12% of Rhabdomyolysis cases die from the disease, which indicates that approximately 588 people died in 2010 from complications of Rhabdomyolysis caused just by Simvastatin in 2010.
| Simvastatin Prescriptions | 2010 |
| # Prescriptions | |
| All cholesterol drugs | 253 million |
| Simvastatin, all doses | 94.3 million |
| Simvastatin alone, 80mg | 11 million |
| Vytorin, all doses | 8.6 million |
| Vytorin, 80mg | 1.3 million |
| Simcor, all doses | 0.94 million |
| Simcor, 80mg | 0.18 million |
| Total 80mg Simvastatin | 12.4 million |
| (Source: IMS Health) | |
The new changes to the drug labels for Simvastatin-containing medicines are based on FDA’s review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency’s March 2010 Ongoing safety review of high-dose Zocor (Simvastatin) and increased risk of muscle injury.
Simvastatin Side-Effects
What is rhabdomyolysis?
Rhabdomyolysis is a rare but very serious condition. It occurs when muscles are damaged and muscle cell contents are released into the bloodstream. If not detected early and treated promptly, rhabdomyolysis may result in acute renal failure, kidney damage, or other organ damage which may be fatal.
What are the symptoms of rhabdomyolysis?
Patients who develop rhabdomyolysis can have several different symptoms, but most often complain about muscle aches involving their calves, back, or their entire body. In addition to this type of muscle pain, weakness, fever, nausea, vomiting, and passing of dark urine can occur.
For some important background facts about this June 2011 FDA action concerning Zocor and these several other simvastatin-containing pills, we turn to Forbes’ pharmaceutical news reporter Matthew Herper and his two recent articles written for his column, The Medicine Show.
All Statin Drugs are Suspect
In August 2001, the cholesterol drug, Baycol (Cerivastatin), was recalled by the FDA and Bayer due to its increased risk of causing rhabdomyolysis. According to an FDA statement released on August 8, 2002, reports of 31 U.S. deaths linked to the cholesterol-lowering drug Baycol led to Bayer pulling Baycol off the market.
Although other drugs of the statin class have been linked to a life-threatening condition called rhabdomyolysis, they have not yet been removed from the market, perhaps not because they are not causing deaths, but because no clinical trials have been done to assess the risk.
With the removal of Baycol, five additional statin drugs remain on the market, including Mevacor and Zocor by Merck & Co., Lipitor by Pfizer Inc., Pravachol by Bristol-Myers Squibb Co., and Lescol by Novartis AG.
If the FDA was more concerned about the safety of the U.S. public than it is about its relationship with and income from the pharmaceutical companies who make these drugs, it would have pulled all of these drugs off the market years ago.
Dr. Hansen’s Rx is a Safer Alternative?
Dr. Hansen routinely takes his patients off of Statin drugs and prescribes the natural supplement Red Yeast Rice Extract that the drug companies copied to make the statin drugs.
Red Yeast Rice is a preparation made from a yeast that is commercially grown on rice grains. The Rice and yeast, which is deep red in color, are ground up into a red powder. Red Yeast Rice Extract contains substances that work together to inhibit the activity of the enzyme necessary for production of cholesterol in the body.
For hundreds of years, the Chinese have used it as a spice, as a food preservative, and to make rice wine. In recent years, Red Yeast Rice Extract has been investigated as an agent for lowering cholesterol and triglycerides. According to one double-blind, placebo controlled clinical trial conducted by the National Medical Association Scientific Assembly, serum total cholesterol dropped 25.9% LDL cholesterol dropped 32.8% and triglycerides were reduced by 19.9% after only eight weeks.[1]
In another clinical trial, 324 patients with hyperlipidemia were administered Monascus purpureus (red yeast) extract for eight weeks. At the end of eight weeks of treatment, the red yeast extract raised high density lipoprotein cholesterol (HDL cholesterol or “good” cholesterol) by 19.6%. The results of the trial indicate the red yeast extract is an “effective and safe preparation in the treatment of hyperlipidemia.”[2]
There are at least nine naturally occurring compounds in red yeast that are chemically related to statins, the widely prescribed pharmaceuticals used for their cholesterol-reducing effects. Red yeast extract has HMG-CoA (menvinolin) reductase inhibitors. These inhibitors may block the enzyme responsible for making cholesterol in the body.
When this synthesis is blocked, the body simply produces less LDL cholesterol, measurably reducing its presence in the blood. In addition, red yeast raises HDL cholesterol to more desired levels. Increases in HDL levels boost cardiovascular health since HDL cholesterol helps eliminate LDL cholesterol from the bloodstream.
Note: It is not known if red yeast extract inhibits the body’s production of CoEnzyme Q10 (as statin drugs do). Therefore, Dr. Hansen recommends supplementation with a minimum of 50 mg of CoQ10MAX twice daily while taking Red Yeast Rice Extract.
R e f e r e n c e s
1. A monascus Purpureus rice preparation reduces serum cholesterol and triacylglycerols in elderly with primaryhyperlipidemia: A randomized double blind clinical trial. National Medical Association Scientific Assembly. August1-6, 1998.
2. Clinical trial of extract of Monascus purpereus in the treatment of hyperlipidemia. Chinese Journal ofExperimental Therapeutics for Prepared Chinese Medicine. 1995, 1(1):1-5C