Cholesterol drug Zocor (simvastatin) dangerous at high doses, FDA says

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(CBS/AP) Is Zocor dangerous? The FDA is warning that high doses of the blockbuster cholesterol drug can harm muscles and cause potentially deadly kidney damage. It's added new warnings to Zocor in an effort to caution doctors about prescribing the drug in high doses.

Regulators said Wednesday that patients taking the 80-milligram dose of Zocor or generic simvastatin are at higher risk than patients taking lower doses of the drug or other statins.

The 80-milligram dose should be used only in patients who have taken it for more than a year without signs of injury. New patients should start on a lower dose, the agency said.

FDA-approved doses for the drug range from 5 milligrams to 80 milligrams.

More than 2.1 million patients in the U.S. were given a prescription for the Zocor or generic simvastatin last year, according to the FDA. Zocor's maker, Merck, said about 12 percent of patients currently take the highest dose of the drug.

"This is an important medicine for these patients because they are at the highest risk for heart disease," said Dr. Michael Rosenblatt, Merck's chief medical officer. "Patients shouldn't stop taking this medicine on their own. They should talk to their doctor."

Patients suffering from the muscle injury, called myopathy, experience pain, tenderness, weakness, and elevation of a muscle enzyme called creatine kinase. The most serious form of myopathy, called rhabdomyolysis, can cause fatal injury to the kidneys. The condition is rare, affecting about 5 out of every 100,000 people taking Zocor for a year.

Other statin drugs - including Lipitor (atorvastatin) and Crestor (rosuvastatin) - can lower cholesterol levels with a smaller risk for muscle injury, Dr. Gregg C. Fonarow, professor of cardiology at the University of California at Los Angeles, told Healthday. He added, "Patients should consider taking this opportunity to discuss with their physician which statin regimen may be most appropriate to improve their cardiovascular health.

The FDA has more on Zocor.

[LLfromCO]

I'm a 50 year old female who had been encouraged for the past 2 years to start cholesterol meds. I started 10mg simvastatin in Dec 2010 at my last physical because my doctor felt that my exercise and diet regime was not helping to reduce my LDLs. My total cholesterol has been in the low 200's ever since my first blood test in my teens. More recently my LDLs have inched up but still borderline. No other health issues except for previously non diagnosed arthritis in my neck and back (which I assumed I had but didn't have it checked out) and joint issues. For the last several years I have been religiously working out and eating healthy (no meat, reading labels, etc.)to counteract my bone/joint issues and addressing potential heart concerns. My mobility/flexibility had been so excellent that the medical community would have laughed at me if I said I was having problems. Unfortunately I listened to my doctor at this visit and went on the 10mg simvastatin. In April 2011, I needed to go on an antibiotic for a sinus infection and within 9 days on the antibiotic developed ciatica. I had been told that I could develop muscle weakness from the interaction of statins and antibiotics but didn't realize that I would feel like a truck had hit me. It wasn't just the sciatica-I started having trouble breathing (felt like my ribs had cracked), my neck and shoulders also went out on me. I couldn't walk. I couldn't carry anything and I had major difficulty rotating my neck. My entire neck and back felt fragile. I immediately went to my doctor, told her I was going off of the statins (which she agreed). She wanted me to go for an MRI but my insurance wouldn't allow it until I tried physical therapy. Instead, I had x rays on my neck and back which essentially said I had moderate to severe arthritis. That was a duh factor for me because I had been working on strengthening all my supporting muscles to keep my neck and spine functional. It's been 6 months and I'm still having major mobility problems. I went through depression (frequent crying), minimal sleep, lots of muscle spasms-I was in so much pain and couldn't find a way to sleep. Basically I was denied all my regular physical activities, as well as, my social outlet. Even though I now religiously do daily pool workouts and see a wonderful PT weekly (weekly expense for me), I still have chronic daily pain and limited movement of my neck and back. My major concern is that I have irreversible muscle damage. I believe that during the months between January and April the arthritis had worsened because of the combination of statins and workouts damaging the muscles supporting my spine. After this major episode happened in April, I then realized that I actually had been having little episodes of enhanced muscle issues (since January) that were not my typical workout aches and pains. I am so frustrated that the "studies" suggest there is a very low percentage of side effects with these meds. I've talked to numerous people in my small town that have had issues with statins and have read so many accounts of individuals with similar stories that I refuse to believe that my occurrence was a coincidence and a low incidence. At age 50 I was physically doing better than I had when I was in my 20s and 30s and basically in one week I aged 20 years. The first PT I went to read my x rays and said all my issues were because of my age and I need to accept it. But, on the other breath, he said he couldn't believe that the x rays were of my neck and spine because I was very physically fit. Needless to say I am now working with an incredible PT who has seen many people who have suffered side effects from statins. This has been a very long haul and I guarantee that I will NEVER go on statins again. No one can convince me to take the chance of ending up in a wheel chair vs. "possibly" preventing heart disease. I read a great article by a Cardiologist who is an opponent of statins who said it the best-why put a patient on a medication that takes away his/her ability to do cardiovascular exercise for heart and mental health? It defeats the purpose for an active individual and it may make a frail individual more frail.
Next time I go for my physical I will be telling my physician to report my experience to the FDA and drug company so they can update their nonexistent statistics. Stop lying to the public!!

[beastringer]

Hello all, and I am glad to be alive today. In January 2001, I started loosing weight, loss of appetite, nausea, just the thought of food or smell of food made me ill. I started becomihg weaker and weaker, to to the point of not being able to stand lat alone walk. My Primary Dr. thought it might be medication overdose of pressure and cardiac meds, to include Zocor. At a dose of 40 mg daily. I was sent for a battery of tests, slowly dc'd over a short period of time, several of the medications that I was taking.By the end of February, I could not get out of my recliner, called for rescue and was taken to the nearest ER. The nurses and Dr's felt I was kidding, kept insisting that I get up and walk, when I couldn't even turn over on the exam table!! They were giving me the 'choice' of returning home with pain medication or being sent to a nursing home. Great choices. I refused both, and being a retired nurse, stood me ground, so to speak. I demanded being admitted for further testing, since nothing had been done at this point.
After three days, I started urinating a dark chocolate urine. Alarmed at this the nurse collected a specimen and sent it to lab. Yes indeed, I was in the early stages of kidney failure. Keep in mind, during this period of time, I could not turn over in bed, nor get myself to a sitting position even for bathroom. I had to rely on two excelent staff members, both strapping men, to lift me out of bed, place me on porta potty, and back to bed.
To make a long story short, yes indeed, at 40 mg. of Zocor for over 5 years, had nearly killed me. I required a muscle biopsy to possitively identify to rhabdo, that was trying to do me in. I had a wonderful team of various Doctors and nurses, that bent over backward to help me recover. Here it is June 2011, and I still have some muscle issues in my right thigh, but am walking. I hesitate when stooping and need extra boost to rise to standing. I work in my garden daily, and rely on the rim of my raised bed planters to get up and down. I am not ever, EVER, NEVER taking in type of cholesterol medications again, will control what needs to be with my dietary intake. Have been told to sue the manufacturers, but am not a vengeful person. I just pray to no one is or gets as incompassitated as I recently was. Medications are great, if enough is known about them. Apparently my cardiologist was not aware of the rhabdo issue, or he would never have started me on it. Sorry Dr. Joe, but I still love you. I evern had the hospital have a complete copy of my medical records printed for me, which is with me with every Dr. office visit I make. I am a lucky statistic.

[clarity55]

I took a different statin for a year. Near the end the word necrotic (dying flesh) kept cropping up in my mind. It felt as if the flesh in my forearms was separating from the bone. My urine started to smell like five day old meat wrappers. I literally believe that my muscles were rotting in my body and I was pissing them out in my urine.
A couple of weeks after I quit (by dosage reduction) statins for ever I took a huge lung expanding breath. Those muscles also returned to normal - perhaps my previous exhaustion was due to lack of breath.
I survived a heart attack in 2006 and survived statins in 2007.

[MaxK341]

Why are doctors prescribing this drug? Cholesterol is NOT a risk factor for heart disease. It is a symptom that artial disease is occuring. They should be treating people with elevated homocystine and chacking their C-reactive protein levels.

[liberalme]

My physicial started me out on Crestor--had lower back muscle pain within the first month.

After much insistance from me, he switched me to the 40mg of Simvistatin, I get mild lower back muscle ache but it's tolerable.
All statins have these side effects, JayfromNC is correct, we as patients have to do our own homework today--whenever a doctor recommends something to me I do my own investigations.

Good luck to you Jay, don't give up there's someone out there who isn't on the payroll of the drug companies who will listen to you.
Yes, many doctors will prescribe meds because they do get kick-backs from the drug companies.

[JayfromNC]

DO NOT TAKE THIS DRUG!!!! It is not safe at any dose. I took the 40mg dose for 30 days and began experiencing sharp muscle spasms and headaches. Even though I stopped taking Simvastatin, I have spent the last 2 years in constant pain, sometimes so severe that I have wanted to die. 19 specialists, thousands of dollars, and still no one will acknowledge the problem might have been Simvastatin. I'm now in the throes of haggling with a fourth pain management doctor. Don't you love how they don't believe you, the idiot patient? They will not perform any actual diagnostic testing like an EMG or a muscle biopsy, although they are perfectly willing to tell me I have headaches, muscle spasms, dystonia, migraines, cluster headaches, TMD, etc. etc.! I have had to do all my own research, request my own treatment, find my own out-of-insurance-network specialists, recommend my own drugs; in short, I have had to be my own doctor. The one physician who has helped me told me about a patient she has treated, a firefighter who took Simvastatin and developed career-ending muscle damage (rhabdomyolysis in his case). Again, DO NOT TAKE THIS DRUG! It exacts a far greater price than just your insurance co-pay.

[JayfromNC]

DO NOT TAKE THIS DRUG!!!! It is not safe at any dose. I took the 40mg dose for 30 days and began experiencing sharp muscle spasms and headaches. Even though I stopped taking Simvastatin, I have spent the last 2 years in constant pain, sometimes so severe that I have wanted to die. 19 specialists, thousands of dollars, and still no one will acknowledge the problem might have been Simvastatin. I'm now in the throes of haggling with a fourth pain management doctor. Don't you love how they don't believe you, the idiot patient? They will not perform any actual diagnostic testing like an EMG or a muscle biopsy, although they are perfectly willing to tell me I have headaches, muscle spasms, dystonia, migraines, cluster headaches, TMD, etc. etc.! I have had to do all my own research, request my own treatment, find my own out-of-insurance-network specialists, recommend my own drugs; in short, I have had to be my own doctor. The one physician who has helped me told me about a patient she has treated, a firefighter who took Simvastatin and developed career-ending muscle damage (rhabdomyolysis in his case). Again, DO NOT TAKE THIS DRUG! It exacts a far greater price than just your insurance co-pay.

[Katebctoo]

This drug should be banned. I took it for 2 months at a much lower dose that 80 mg last spring and nearly landed in a wheel chair. Excruciating joint pain in my ankles, knees and left hip (there was no previous problem or injury). Needless to say I quit the drug. One year later I'm still suffering from my hip "cracking" when I walk. Give me a choice of living like that with low cholesterol for 5 years or 1 year of my normal quality of life - I'll take the 1 year!