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:
- Weakness; and
The broken-down muscle mass can cause other problems throughout the body such as:
- Electrolytic disturbances;
- 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
- “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.