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A recent study by the Oregon Health & Science University shows that the cholesterol lowering statin drugs may cause a muscular eye disorder.
Dr. F.W. Fraunfelder led the study, looking at reports of double vision (diplopia), drooping of the upper eyelid (ptosis), and loss of full range of motion of the eyes (ophthalmoplegia) in the databases of the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, and the Food and Drug Administration.
Statins are known to cause muscle problems in some patients, but this is the first report linking statins to muscle problems of the eye. Statins work by preventing cholesterol from forming. This may be good for preventing heart disease, but can cause problems in muscle by preventing the tissue from repairing and regenerating normally. Other muscle problems experienced by statin users include muscle aching, pain, inflammation, weakness, and deterioration of the tissue.
The eye disorder was rare, occurring in 0.1 percent of patients, but those who were taking gemfibrozil (another cholesterol lowering drug) at the same time as statins were at a higher risk with 0.5 to 2.5 percent occurrence.
Of the 256 patients reported on, 23 lost eye range of motion, 8 had drooping upper eyelids, and 18 people experienced both double vision and drooping eyelids. All patients’ symptoms went away after they stopped taking statins. The study was unable to determine which eye muscles were involved based from the patient database information or how long it took for them to fully recover.
Please share your thoughts and experiences! Have you or someone you know experienced side effects from taking Lipitor?
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Millions of patients in the U.S. use cholesterol lowering drugs like Lipitor (made by Pfizer) or Zocor (made by Merck) in an effort to lower heart disease risk. Last year, the patent protection for Zocor expired and the generic form of it called simvastatin was put on the market. Since generic simvastatin became available, health insurers have been pressuring doctors and patients to switch from brand name cholesterol lowering drugs like Lipitor to this similar and much cheaper generic form of Zocor.
Price is the main reason people are switching to the generic simvastatin. Currently it costs about $2 per day for Lipitor, but with the generic brand it is closer to 35 cents or less. Switching over could save billions of dollars in health care costs.
Both Lipitor and Zocor are from a drug class called statins. Statins work by inhibiting the enzyme that produces cholesterol. Other cholesterol-lowering drugs from this class include Crestor (rosuvastatin), Pravachol (pravastatin), Lescol (fluvastatin), and Mevacor (lovastatin).
Compared to Lipitor, Zocor (simvastatin) is less potent. Therefore, if you were taking 10 mg of Lipitor, you would have to take 20 mg of the generic Zocor. Currently, the highest dose you can get of Zocor is 80 mg (equal to 40 mg of Lipitor). This means that if you are presently taking more than 40 mg of Lipitor you will not be able to get a strong enough dose. For most people this shouldn’t be a problem.
By law, the generic version of Zocor is required to contain the same active ingredients as the brand name. They also have to the same dosage, potency, quality, function, and approval from the FDA.
Both Lipitor and Zocor share similar side effects because they are from the same statin drug class. Not all of the side effects are known; some patients experience headache, muscle pain and weakness, muscle tissue breakdown (rhabdomyolysis), memory loss, postoperative delirium, and others. (For more side effects check out: Five Biggest Risk Factors in Taking Lipitor or Other Statins)
What do you think? Have you experienced any differences since switching to the generic form of Zocor? Please share your experiences!
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More and more evidence is pointing towards statin drugs causing muscle pain and even debilitating muscle problems.
There are generally three types of muscle trauma that people experience from statin medications, says Dr. William Shiel, a specialist in muscle and joint conditions. The first is muscle aching, which typically goes away within a couple weeks after stopping statin treatment. The second experience is muscle pain and mild muscle inflammation with or without a feeling of weakness. A blood test may reveal elevated levels of CPK enzymes which typically mean that the skeletal muscle is injured or under stress. This can take up to a few months to heal. The third condition (rhabdomyolysis) is most serious involving severe muscle inflammation, weakness, and the breakdown of muscle. Patients experience muscle damage and pain throughout their entire body. Elevated CPK enzymes can also accumulate and damage the kidney.
Jill Slade, assistant professor of radiology and osteopathic manipulative medicine at MSU, believes that the muscle damage caused by statin drugs is underestimated. Her current study is following 50 patients on statin medications to track their muscle integrity through magnetic resonance imaging. “While statins have tremendously helped millions of Americans lower their cholesterol and improve their cardiac health, we need to be confident we are not causing other problems in the body,” Slade said. “Statins work by preventing cholesterol from forming. While this is a good thing inside structures such as liver cells, it can be problematic in places such as muscle cells.”
A recent study at the University of Alabama supports this. It shows that statins may prevent skeletal muscle from repairing and regenerating normally due to the anti-proliferative effects of the drug. The researchers also agree that the current 7 percent of patients reporting skeletal muscle problems may not be accurate. Dr. Anna Thalacker-Mercer said, “It is possible that older adults may not be able to distinguish between muscle pain related to a statin effect or an effect of aging and therefore adverse effects of statins in older adults may be under-reported.”
Dr. Shiel stated that it is important for patients and doctors to be extra aware of this potential side effect because it is easier to treat the sooner it is found. “When discovered late, it can lead to serious injury—not only to the muscles but also potentially to the kidneys and heart.” In 2001 the FDA pulled one statin drug, Baycol, off the market because it was shown to be the cause of 31 deaths from muscle tissue breakdown (rhabdomyolysis). From Dr. Shiel’s experience, “Of all causes [of muscle pain] statin drugs are what I see as the most common culprits.”
What do you think? Have you experienced any muscle pain after taking statin drugs like Lipitor? Please leave a comment about any side effects or experiences you have had with this drug!
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A new study reported in the New England Journal of Medicine shows that taking statin drugs like Crestor or Lipitor may prevent heart disease even if you don’t have high cholesterol levels.
The study looked to test whether statins could prevent heart disease in patients with normal cholesterol levels but high C-reactive protein (CRP) levels. C-reactive protein is a biomarker used to measure the levels of inflammation, which is thought to play a role in half of all cardiac events. Inflammation has a compound effect on the amount of LDL cholesterol absorbed by artery walls and can lead to further plaque buildup (See our article on The Role of Inflammation in Heart Attacks).
The clinical trial included 17,802 men and women from different parts the world with cholesterol levels less than 130 mg/dL and CRP levels above 2.0 mg/L. Participants were given 20 mg of rosuvastatin (Crestor) or a placebo.
After 2 years, the 5 year study was ended because the endpoints had been met. The results showed that statins lowered the risk of cardiac events by 44 percent. The statins were shown to lower LDL cholesterol by 50% and CRP levels by 37%. The total number of deaths was 20% less in participants taking statins compared to the placebo group.
The new findings could rework who is eligible for statins, potentially adding 10 million more Americans to the existing 36 million already taking a statin drug. Currently, only people with high LDL cholesterol levels are prescribed statins. This study may help validate CRP levels as an additional test to determine people at a higher risk for heart disease.
Do you think statins should be prescribed to people who don’t have high cholesterol levels? Please share your opinions and experiences with statin drugs!
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A recent study shows that the cholesterol-lowering statin drugs like Lipitor reduce the blood marker for prostate cancer but don’t necessarily decrease the risk of developing it. Prostate specific antigen (PSA) is a protein produced by the prostate gland that is usually present in small amounts for healthy people. Higher PSA levels occur when there is prostate cancer, and testing for this protein is currently the most effective way to screen for this disease. Statins seem to lower PSA levels but don’t necessarily lower the risk of cancer. This can potentially cause men who would otherwise be diagnosed and treated for the cancer to be passed over as cancer free.
The study included 1,214 men without prostate cancer who were prescribed statin drugs between 1990 and 2006. Duke researchers found that PSA levels dropped 4.1 percent on average. PSA levels appeared to drop the most in patients who took higher doses of statin drugs and experienced larger decreases in LDL cholesterol.
Further tests are needed to determine if statins may help to prevent and treat prostate cancer, or if they only lower PSA levels.
Have you experienced any side effects from using statin drugs? Please share your experiences and opinions!
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Pfizer is moving research dollars away from Lipitor and heart disease research so that it can go after potential profits in cancer, diabetes and Alzheimer’s disease drugs. Lipitor has been Pfizer’s blockbuster drug as well as the highest selling pill on record. Last year, Lipitor made almost $13 billion in revenue, accounting for 25% of Pfizer’s sales.
A major reason for Pfizer’s shift in direction is its soon-to-expire patent protection on Lipitor in 2011. Furthermore, Lipitor has been losing part of its market in the last couple years to the generic form of its rival, Zocor, produced by Merck. This started when Merck’s patent ran out and health insurance companies began initiatives to support the generic form of Zocor called Simvastatin. Since then, patients have been switching over to this cheaper cholesterol lowering drug.
In addition to stopping research, Pfizer will sell several of its current early stage heart disease medicines because they don’t believe they will be profitable enough.
As Pfizer restructures, they will also be starting three new business branches in 2009. The branches will include primary care, specialty care, and emerging markets. The primary care branch will continue to work with doctors to increase and promote the use of Lipitor like drugs.
What do you think of Pfizer’s choice to stop research in heart disease medicines? What effects do you think this will have on the current market? Please share your opinions!
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RateADrug.com is an interesting new site where users from the community rate their experience in using different prescription drugs. Currently there are over 3,000 medications to view and share experiences about. Detailed surveys include things such as drug effectiveness, how much and how long you have been taking the drug, changes in well being, side effects, and user comments about the drug.
This is a good way for patients to stay updated with the most current side effects as well as learn about new alternative treatments. Additionally, after you fill in your experiences with your drug, you will receive your personal risk/benefit analysis based from your question responses. This gives you a score from 1 to 10 for both your side effects and positive effects so that you can see how this drug is working for you and how that compares to other users. It’s also great because you can forward all of your surveys along with comments to your doctor, family member or caregiver to keep them informed about any changes in your health caused from existing or new medications.
Go to RateADrug.com to take the Lipitor drug survey and see what people are saying about it.
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Statins may increase risk of postoperative delirium in elderly patients according to a recent article published by the Canadian Medical Association Journal. Delirium is a sudden and severe change in cognitive function causing confusion, inability to concentrate, and sometimes hallucinations. It is commonly experienced after surgery in people over 70, and it can cause delayed recovery, increased hospital costs, and anxiety for the patient. Sometimes the patient never fully recovers and stays at a permanent level of dysfunction.
The study looked back at the medical records of over 280,000 patients in Ontario who were 65 or older and went in for elective surgery. About 7 percent of patients were using statins and just over 1 percent, or 3195 patients, experienced postoperative delirium. 1 in 90 patients using statins before their surgery experienced post-delirium, showing the risk to be 30 percent higher than those not using statins. The correlation seemed to be greater for patients using higher doses of statins and undergoing a longer surgery time. The risk between statins and delirium was not seen in any other cholesterol lowering drugs.
One theory is that statins may cause altered blood flow within the brain which would cause a temporary lack of oxygen to neurons and predispose patients to delirium. This shift in blood is produced by a change in endothelial nitric oxide synthase within small blood vessels. This is an effect caused by statins, which is not even related to lowering cholesterol or preventing heart disease.
Even though the percentage of people experiencing this is on the low end, it would affect many people due to the large number of elderly patients taking statins and undergoing surgery. One recommendation or compromise is to stop taking statins a few days before surgery and restart after.
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Statins may be effective in lowering cholesterol – but at what cost? With the high price of statin drugs and potentially undesirable side effects, many people have begun looking into supplements as an alternative to lowering cholesterol.
Omega-3s are essential fatty acids, meaning they can’t be manufactured by the human body yet they are essential for good health. Omega-3s lower triglycerides, increase HDL “good” cholesterol, and lower high blood pressure. The American Heart Association recommends eating fish twice a week to get your omega-3s, or you can take it as a supplement. One new study by Professor Luigi Tavazzi and Professor Gianni Tognoni , GISSI-HF Coordinating Centre, ANMCO Research Centre, Florence, Italy compared the effectiveness of taking a one-a-day capsule of omega-3 polyunsaturated fatty acids to taking statins. The results concluded that taking omega-3 can effectively reduce hospital admission and mortality rate for cardiovascular issues in heart failure patients. Statins, on the other hand, proved to not have any affect in the mortality outcome of patients.
An herbal supplement called red yeast rice has been used in traditional Chinese medicine for centuries. Red yeast rice contains lovastatin, the same active ingredient as the prescription statin drugs. Made from a rice extract fermented with red yeast, it is shown to significantly lower LDL levels. In a study from the July Mayo Clinic Proceedings, one test group was given prescription statin drugs with written diet and exercise guidelines. A second group was given red yeast rice, omega-3 supplements and in-depth diet, exercise and relaxation counseling. The findings were almost exactly the same, with a drop in LDL levels of 40 percent for each group. Despite these results, red yeast rice may also cause similar side effects as statins due to the same active ingredient lovastatin. Additionally, it is difficult to know the exact quality of red yeast rice because it is not closely regulated by the FDA.
While a lot of attention has been put on lowering LDL levels, research is showing that raising HDL cholesterol is just as important. It is thought that HDL cholesterol picks up excess bad cholesterol in your blood and takes it back to your liver for disposal. Niacin, or vitamin B-3, has long been used to increase HDL levels. Studies show that niacin reduces LDL levels up to 20% and boosts HDL cholesterol by about 35%. Niacin also seems to lower lipoprotein A, which is another risk factor for atherosclerosis. Despite these benefits, niacin may cause flushing and raised blood sugar. It should be taken under the supervision of a health care professional.
Additional supplements that may have cholesterol lowering effects include blond psyllium seed husks, artichoke leaf, soluble fiber, plant sterols, garlic, flaxseed, Metamucil and policosanol to name a few.
Have you been diagnosed with high cholesterol? Have you decreased your cholesterol levels? If so, by what means? Have you found that “natural” supplements have helped you establish lower cholesterol levels without side effects? Share your experiences!
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www.RateADrug.com has a page where you can rate your experience taking Lipitor as well as other statins. Here you can voice your opinions about side effects, benefits, and get an effectiveness score of the drug you are taking. Very interesting results…
Take the Lipitor Survey, click HERE
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TONY N SMITH wrote:
Willie B. Beasley wrote:
anon wrote:
30. December 2008 at 10:01 am :
I’ve been on simvastatin for 3 or 4 months and have experienced growing problems with diplopia over that time. (I had some minor problems with it before going on the drug.) I am relieved to have discovered a possible explanation for my problem and will talk with my family doctor and opthalmologist about this possibility. Thank you for this posting!