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Statins Side Effects Can Cause Diabetes, Memory Loss, FDA Warns

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Federal health regulators are warning that cholesterol lowering drugs like Lipitor, Crestor and Zocor could increase the risk of diabetes, muscle injury and could cause cognitive impairments like memory loss and confusion. 

The FDA announced this week that it was requiring new label warnings on a number of drugs known as statins to alert the public on several new concerns.

Some of the concerns, like those of myopathy, a form of muscle injury, have been known for some time. Others, like concerns of cognitive impairments, are new warnings that come following years of investigation.

The drugs affected by the new label warnings include: Advicor, Altoprev, Crestor, Lescol, Lipitor, Lovalo, Mevacor, Pravachol, Simcor, Vytorin and Zocor.

Statins are the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease.

The new label warnings will include information from a number of studies that suggest that statins increase the level of blood sugars, resulting in an increased risk of Type 2 diabetes. One study found a 27% increase in diabetes among statin users, while another study calculated that there was a 9% increase in the risk of diabetes among statin users. One study specifically looked at Lipitor and found that it was associated with worsening glycemic control.

Concerns over cognitive impairments came from a review of the FDA’s adverse events reporting system (AERS) database as well as clinical trials. The agency received a number of adverse event reports that warned that some statin users over the age of 50 suffered memory loss and confusion while taking statins. According to the reports, the problems ceased and their cognitive abilities returned to normal when the patients stopped taking the drugs.

The FDA also singled out Mevacor for new label warnings of muscle injury, which the agency says can occur when it is taken with other drugs. The new warning will list what drugs should not be taken at the same time as Mevacor.

Statins have been linked to muscle damage before. Studies have found that about 1 in 10,000 statin users develop a sometimes-fatal muscle condition known as rhabdomyolysis. The rare condition causes skeletal muscle damage and releases myoglobin into the bloodstream. The myoglobin can cause severe kidney failure or death.

In 2002 and 2008, the FDA issued warnings about the increased risk of rhabdomylosis when statins are used in combination with heart medication containing amiodarone.  In 2001, the statin-based drug Baycol was removed from the market due to its links with rhabdomyolysis.

In June 2011, the FDA updated the warning label about the risk of rhabdomyolysis from Zocor 80mg doses, specifically indicating that users may face an increased risk when that higher dose statin is used. As a result, a number of individuals throughout the United States are now considering a Zocor lawsuit against the drug makers for promoting the 80mg dose without adequate warnings.

While the FDA added new warnings to statins, it dialed back concerns of statin liver damage, removing recommendations for routine periodic monitoring of liver enzymes. After determining that the liver injuries appeared to be more rare than first suggested, the FDA is now calling for a liver enzyme test before starting statin therapy, and then as clinically indicated thereafter. The FDA said that serious liver injuries have turned out to be rare and unpredictable, and the routine monitoring did not appear to effective.

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12 comments

  1. Louis Reply

    I have taken this drug in one form or the other. I have wondered about my memory for guite awhile, short term, but have not had anyone to go to about it.

  2. bob Reply

    after numbness and pain in my leg got unbearable..i stopped taking the drug. When my doctor found out he said …”oh yeah ..those high doses and your blood pressure medication turns out is not recommended”, as he read in a study 4 or 5 months ago..he we will go on a lower does when that clears up.. After reading all these side effects will it clear up? i hope so ….and if he read this study why was i still on this combination of pills?

  3. Brenda Reply

    I have been taking simvastin (Zocor) for about 10 years or more. I was diagnosed with Type 2 Diabetes last year. Besides that, I have had short term memory lost for some time now.

  4. William Reply

    My mother has been on Lipitor for years and not one time were any potential side effects mentioned by her doctors. Now I wonder if all her health problems for the last decade have stemmed from this drug. She started having muscle weakness shortly after starting Lipitor, she started having to take diabetes medication, she lost feeling in her feet (thought it was diabetic neuropathy), and she has had increasing confusion and memory loss over the last 5 years. I just took her off of Lipitor (its now been about a week) after seeing the news reports for the first time. Her blood sugars have already started improving, and she has feeling in her left foot for the first time in years. She has been diagnosed with Alzheimer’s, and has had a very slow but increasing memory loss. Now I’m wondering if it wasn’t the Lipitor. She seems to be somewhat better with memory and mood, but that may be wishful thinking. Could the longterm use of Lipitor have atrophied her brain? I’d sure like to know.

  5. Sts Reply

    Statins are very profitable. What is crodisened normal range of cholesterol has been lowered from 220 to 200 to 180. What is recommended for some people is cholesterol levels that can ONLY be obtained with statins. Much of the research supporting the use of statins is paid for by the companies producing the drugs. Highly suspect, in my way of thinking.Notice that even in men who had previously suffered heart attacks, the statins did not decrease overall deaths, just another heart attack. Some of those deaths may very well have been caused by strokes, a known risk of statin drug usage.Unless you have a rare genetic disease, it’s very easy to lower your cholesterol into the normal range, get the ratio between HDL and LDL righted, and lower your triglycerides.Eat LOTS of good fats (butter, olive oil, palm oil, peanut oil, and best of all, coconut oil), take a natural cod liver oil supplement, cut out transfats (most salad oils and all shortenings), eat whole foods like beef, pork, chicken, vegetables, fruits, and eliminate refined starches and sugars.

  6. Dale S Reply

    I must be one of those that have the genetic defect mentioned above. In the beginning I tried a vegan diet coupled with lots of olive oil and one of the fish oil supplements. Throw in high doses of garlic and the huge doses of vitamin B alone with the resin that is found in oatmeal (I can’t remember what the compound is called) and they helped some but when your numbers are more than double the norm it is of little help to lower them by 30 to 40 points. My HDL’s were always below 15 and due to the triglycerides being so high (800 to 1000) it was impossible to determine my LDL’s. My grandfather and father both had heart attacks at relatively young ages (30’s and 40’s) and both died of heart attacks (one in his 30;s and the other at 60). I have had an angiogram in my early 40’s and found to have significant blockage so it is a verified fact that I have issues that these drugs help. I have taken multiple different medical approaches to treating my cholesterol problem and each had a positive affect but not significance enough to be considered as a solution. Even together the non-statin treatments could not get my total count below 350. I started with Mevcor then Lipitor and now Crestor in maximum dosage and even at that I am only in the 200 to 220 range and my HDL’s are 35 to 40 . I think for me it has been a life saving therapy. I started using statins as soon as they were on the market so it has been long term usage. I was also moved to the highest doses allowed by the FDA quickly to get my numbers within a tolerable range and keep them there. I am not over weight (190 lb’s at 6′ 2″). At age 60 I found I have type 2 diabetes (my A1C was 12.6) when first diagnosed. I also think I have considerable memory loss in recent years. I never had a clue that they were possibly linked and caused by the one thing I feel is critical for extending my life expectancy. Nothing comes for free. I used to worry about my liver but it looks like that was a false alarm. I am not sure what to do with this information as there is no clear answer but at least I have some idea of what might be causing these issues now.

  7. Linda Reply

    The VA here in Iowa is really big on trying to push veterans onto simvastatin. I suffered from the memory problems but did not connect them to the statins for over three years. I also took so much aspirin for my carpal tunnel that I couldn’t tell if I suffered muscle pain due to the statins. I no longer take simvastatin, but still have some weird memory issues. Statins also seem to mess up your vitamin D levels, which also affect memory. Also, my cholesterol did not come down much with even 80 mg of the simvastatin. I later found an research article that stated that people with undiagnosed hypothyroidism were often found to be resistant to the statins. You should know that you can be hypothyroid and still show up as “normal” on the typical lab tests used to check your thyroid (the usual tests miss a lot of cases). Also, for those who have not yet found them, Dr. Duane Graveline has a lot of information about the statins at spacedoc.net, and Dr. Beatrice Golomb heads up the long-term “Statin Effects Study” being conducted at the University of California at San Diego. Please learn more about the statins and do what I do — tell people you meet in checkout lines about them. Last year, I met a woman who was suffering from muscle/joint pain so bad that she was afraid of doing stairs. I suggested it might be a statin (she had recently started taking one) and she checked out the side effects on the Internet, stopped taking her statin, and her pain was gone within a week (probably saved her kidneys). Anyway, you might really help someone out by giving them more info about the statins.

  8. Florence Reply

    Interesting how everything gets brushed under the carpets. I have recently been diagnosed with Type II Diabetes and my short term memory is about shot. I have been on statins for the last 12 years.

  9. MF Reply

    I had significant upper right quadrant pain over my liver that persisted on and off for 2+ years. I didn’t put two and two together because the symptoms came on approximately 3 years after starting on Simvistatin. I also had deep muscle aches in my thighs, muscle weakness in my legs and a very hoarse voice which is also considered a side effect.

    My doc took me off Simvistatin and put me on a weaker statin but the upper right quadrant pain started again within 60 days and muscle aches as well. I took myself off the med due to these problems.

    I do not have high cholesterol but rather inverted LDL/HDL levels.In the past, I’ve gotten my total count to 151 total cholesterol without meds (I ate well and worked out) but the highest my overall count is these days is around 200-220 with bad ratios.

    The URQ pain and muscle weakness (referred to as “muscle damage” by some) is just not worth it. It feels like I’m damaging my body.

  10. Brenda Reply

    For the last two months I have been eating healthy, drinking lots of water and exercising. I\\\’ve lost 20 pounds. Before I began this my cholesterol was at 199. Now that I\\\’ve made these healthy changes its 250! I only found out I had an increase in my cholesterol when I had a mini stroke about 2 weeks ago. I am only 41 years old. In addition I am a smoker. I found out my heart and arteries are good. That it was my cholesterol and possibly in my small blood vessels. I\\\’ve been put on 20 mg of Lipator. I\\\’m soppose to take it at bedtime, because I also take 30 mg of Prozac in the morning. I have become extremely tired and feel worn down. I seem to have a hard time expressing my self by forgetting what I\\\’m talking about or can\\\’t remember the word I wana use in mid sentence. Its frustrating because I\\\’ve always been a quick thinker, and even was shortly after the mini stroke – subtracting numbers and reading sentences for the neurologist. So I\\\’m wondering if this Lipator is affecting me poorly??? Has anyone else taken Lipator after a mini stroke?? If so has it made you feel worn out???

  11. Lynn Reply

    My husband started taking Zocor about 4 years ago after a bout with high blood pressure. Within a short time he became very quiet , had trouble communicating and speaking. He had a loss of muscle and a very noticeable change in his appearance. Doctors have given me 4 different opinions as what is going on. He has had no stroke ? ?? No brain injury , they all seem to think he has Aphasia or left frontal dementia. I see no loss of memory , or deterioration in his condition . Doctor took him off of Zocor over a week and I am seeing improvement . Any one else out there no of anything similar like this happening ?

  12. April Reply

    I lost my job due to memory lapses. Saw my dr and he stopped lipitor. Less than 2 weeks later the fog lifted. I can’t find any atty that is interested in memory loss, only diabetes and lipitor. I live near DC and Baltimore.

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