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Simvastatin, Amiodarone Side Effects Lawsuits

The anti-cholesterol/anti-arrhythmic drug combination of simvastatin (sold under several brand names, including Zocor, Simlup, Simcard, and Simvacor) and amiodarone (sold under the brand names Pacerone, Cordarone, and Aratac) has been identified as a possible cause of serious muscle problems. Simvastatin also causes other side effects such as liver damage, diabetes, and memory loss. If you have taken this combination of drugs and you believe it caused you to develop a muscle disorder or some other negative side effect, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group knows this, and we want you to believe it.

What Are Simvastatin + Amiodarone, and What Are They Prescribed For?

Simvastatin is a member of the statin class of anti-cholesterol drugs that scientists first started investigating in the 1950s. Like all statins, simvastatin prevents the metabolic creation of cholesterol by blocking critical enzymes. The Food and Drug Administration (FDA) approved it in December 1991, and it is now available generically. It often appears in Merck’s Zocor and Abbott Laboratories’ Simcor and is a component of Schering-Pkough’s Vytorin.

Amiodarone is the generic name for an anti-arrhythmic drug (i.e., a drug used to reduce heart irregularities). Though it was first discovered in 1961, the FDA did not approve it until 1985. It is one of the most effective anti-arrhythmic drugs, though weaker ones have less severe side effects. In the United States, it is manufactured by Upsher-Smith Laboratories (as Pacerone) and Wyeth-Ayerst Laboratories (as Cordarone). It works by lengthening a portion of the heart’s electrical activity.

Both drugs have several side effects. Of particular concern for amiodarone is serious lung diseases: interstitial lung disease and pulmonary fibrosis. Other side effects appear in the thyroid, eyes, gastrointestinal system, liver, and skin.

Despite two labeling changes, the FDA continues recording problems with the simvastatin/amiodarone drug combination. Each of the drugs is appropriately labeled for separate use, and there are no recalls for the individual drugs or for the simvastatin/amiodarone combination. The FDA released a February 2012 drug safety communication advising the public about several statin-related side effects caused by simvastatin.

Simvastatin + Amiodarone Might Cause Muscle Disease

In 2002, the labels on simvastatin products were changed to warn patients that, when used in doses greater than 20mg daily along with amiodarone, simvastatin puts patients at an increased risk of developing rhabdomyolysis—a disease characterized by atrophying skeletal muscle tissue. In August 2008, the FDA issued a second warning because it had received 52 more reports of rhabdomyolysis since its 2002 warning. In 2011, the FDA revised simvastatin’s dose limitations, when combined with amiodarone, down to 10mg per day but then it reversed itself and brought them back up to 20mg per day, which it announced in a December 2011 simvastatin drug safety communication.

In a patient with rhabdomyolysis, the lost muscle tissue (myoglobin) collects in patients’ blood and can cause severe kidney problems or even death. Most of the time, this disease is caused by severe injury such as a muscle being crushed by an object, and in other cases it arises due to extreme alcohol abuse. Primary symptoms include:

  • Pain;
  • Tenderness;
  • Weakness; and
  • Swelling.

The broken-down muscle mass can cause other problems throughout the body such as:

  • Electrolytic disturbances;
  • Nausea;
  • Vomiting;
  • Confusion;
  • Coma;
  • Cardiac arrhythmia;
  • Dark urine;
  • Oligura or Anuria (decreased or non-existent urine production, respectively); and
  • Internal blood clotting.

Treatment includes rapid rehydration, as most cases of rhabdomyolysis are caused by sudden incidents. Doctors may also prescribe various drugs to cause myoglobin to disintegrate. In extreme cases, they’ll put patients on dialysis.

Later, in March 2012, the FDA warned the public that simvastatin use combined with certain other drugs, namely “protease inhibitors” meant to treat HIV and hepatitis C, can raise the amount of simvastatin in users’ blood, which can cause myopathy. The FDA contraindicates using simvastatin with these drugs.

Simvastatin + Amiodarone Might Be a Diabetes Risk Factor

On January 9, 2012, the medical journal, Archives of Internal Medicine, published a study analyzing a possible association between statin use in women and type 2 diabetes. The researchers investigated 161,808 women between the ages of 50 and 79 years old who participated in the Women’s Health Initiative over the course of several years. They found that women who took drugs belonging to the statin class were 48 percent more likely to develop type 2 diabetes than women who did not. The researchers concluded that “statin use is associated with an increased risk for [type 2 diabetes].”

In February 2012, the FDA changed simvastatin’s drug label to reflect the increased risk.

Simvastatin + Amiodarone Might Cause Liver Injury Side Effects

The FDA also determined that statin use has been associated with liver injury in rare instances. Symptoms of simvastatin liver injury include:

  • Unusual fatigue
  • Loss of appetite
  • Right upper abdominal discomfort
  • Dark urine
  • Yellowing of the skin or whites of the eyes

Simvastatin + Amiodarone Memory Loss Side Effects

Also in the February 2012 update, the FDA informed the public that it was investigating reports of simvastatin memory loss that occurred to users who had been on the drug for several years. Symptoms arose in every age group, though more often in patients over the age of 50. Examples are:

  • Memory loss
  • Forgetfulness
  • Confusion
  • “Fuzzy” or unfocused thinking

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a simvastatin and amiodarone lawsuit on your behalf if necessary.

If you have taken simvastatin and amiodarone and experienced adverse side effects, contact RLG today.

RLG Knows There’s a Better Way

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rlg Previous Comments

  1. Guest
    on May 6, 2012 at 6:35 pm

    My 76 yr old mother has been taking Amiodarone for several years - she has developed lung fibrosis and pneumonia as well as pleural effusion, r/t the Amiodarone.

  2. Guest
    on March 6, 2012 at 9:13 pm

    I suffered muscle mass loss and inexplicable weight loss when my doctor switched me from herbal statin (red yeast rice and niacin) to simvastatin. I voluntarily switched back. Then I was diagnosed with chronic kidney disease (stage 3). Very recently I was tested and cholesterol level has gone up and I have liver enzyme increase. I see my family doctor and nephrologist on 3/13/2012.
    My family doctor was prescribing the simvastatin without any blood work, too.

  3. Guest
    on December 13, 2011 at 3:52 pm

    I have been on Simvastatin for years. On Simvastatin 80 for at least 1 1/2 years. I keep telling my Doctor that my body is killing me with aches, pains everywhere. I was told it was old age. I'm not old and in fine shape. I was never asked about my urine (which is dark) or to have a test. I have never been told about the dangers of 80 milligrams and will lower my intake to 40 as of tonight. How can I tell if I've damaged my aching muscles?

  4. Guest
    on September 28, 2011 at 4:42 pm

    At the time of open heart surgery, a return to rapid heart beat lead the attending doctor to place me on Amiodarone. The doctor thought I would require another ablation within a short period of time and therefore would only be on Amiodarone a few months. Turns out I was on the medicine about one and one half years during that time developing side effects. Within a couple of months of stopping the Amiodarone, I loss total sight in the left eye. Sight did return to about 50% and has remained at that level. The right eye is affected to some lesser degree. Not knowing what the problem was, I went to the eye doctors that had done lens replacement a few years earlier. First I was told that I had oracular degeneration, a second doctor said no you had a stroke. Not feeling convinced I went to another eye firm and the first doctor there said I did not have a stroke but had a hole in the retinal. A fourth doctor said I did not have a hole in the retinal and after many tests said he did not know what was wrong with my eyes. Two of the four eye doctors asked if I was taking Amiodarone. I told them that I had taken that drug. They both responded by saying that they could see scaring in the back of the eyes from the drug. Brain scans were done all showing negative. I will now see an optic nerve specialist as the thought now is that the problem lay with the drug Amiodarone. Any further deterioration of my sight will render me unable to drive. If you are on this drug do watch for the side effects.

  5. Guest
    on July 26, 2011 at 9:13 pm

    I have been on Amiodarone since 2002, I am taking 300mg a day and have had side effects. I have lost sight in one eye and had other side effects as well, my thyroid is damaged also.

  6. Guest
    on July 1, 2011 at 5:32 am

    I've been taking simvastatin for a year. 40mg and I have pain on my side. I went to a clinic and they ran a blood test on me and my ck was 12790. I was hospitalized for 5 days, I had just started back to work after being laid off for 19months and now this, I was told that I had rhadomyolysis.

  7. Guest
    on May 17, 2011 at 2:13 am

    I also experience tingling and swelling in feet and some tingling in hands.

  8. Guest
    on May 17, 2011 at 2:12 am

    I have been taking 200 mg of amiodarone for about 6 years; I am now in stasis after surgery at that time. I have been taking 40 mg simvastatin but recently stopped because of tingling in feet and tightness around arches and ankles; I seem to be suffering from muscle loss and have balance problems. Any thoughts that my symptoms are related to the interaction of these two drugs. (I have difficulty losing weight; weigh 160 lbs and only 5 feet tall; 77 years of age; female.

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