Amiodarone and Simvastatin Rhabdomyolysis Interaction

For the time period 11/1/97-10/21/02, the FDA Medwatch reported over 3,900 adverse events associated with amiodarone, including 452 deaths. (According to Medwatch, 1-10 percent of side effects are reported, so it concludes that 4,520 people have died as a result of taking Amiodarone in that 5 year period alone). The vast majority of these reports involve side effects serious enough to require hospitalization. Others involve blindness or permanent damage to lungs, liver, thyroid or the nervous system. Causes of death include: Respiratory failure due to lung damage, liver failure, kidney failure, failure of multiple organs (e.g. lung, liver and kidney), congestive heart failure, heart arrhythmias (including sinus arrest, ventricular tachycardia, cardiogenic shock, and torsades de pointes), stroke and bone marrow depression.

Amiodarone Class Action Lawsuit

Amiodarone is routinely prescribed for atrial fibrillation and other common heart conditions, but the FDA only approved amiodarone for more severe disorders, called ventricular arrhythmias, and then only as a treatment of last resort. In August 2008 the FDA notified healthcare professionals of the risk of rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone.

A class action lawsuit has been filed against Wyeth and several other makers of the highly toxic heart drug on behalf of patients and their families. (Amiodarone is sold by several generic manufacturers, as well as under another brand name, Pacerone.) The suit alleges that there has been a scheme by drug makers for the past 20 years to pressure physicians to prescribe the drug for unapproved uses while concealing and downplaying its risks. The suit further claims that amiodarone continued to be prescribed to millions of patients nationwide without the detailed consumer warnings issued by the FDA.

The class action lawsuit filed in New Jersey accuses drug makers of promoting amiodarone for common heart ailments in an effort to boost profits. The suit claims that more than 1,000 people died, 100 had vision problems and thousands of others suffered severe medical complications.

Amiodarone History

Although amiodarone was approved in Europe and Canada and was commonly used in the 1980s, the FDA was reluctant to officially approve the use of amiodarone, since initial reports had shown increased incidence of serious pulmonary side effects of the drug. The FDA recognized that it was a dangerous drug and told doctors to be careful about its use.

In December 1985, amiodarone was approved by the FDA for the treatment of arrhythmias, allegedly due to threats from the European pharmaceutical companies to cut the supply to American physicians if it were not approved, therefore amiodarone was approved by the FDA without rigorous randomized clinical trials. Amiodarone has been approved for problems with the ventricles (large pumping chambers) of the heart, but not for fibrillation (quivering) of the atria (small chambers of the heart). Doctors often prescribe this highly toxic heart drug off-label, however.

The American Journal of Cardiology (January 1, 2003) reported that the number of prescriptions for class III antiarrhythmics more than doubled between 1995 and 2000, due primarily to an increase in the number of prescriptions for amiodarone. But the authors of the report stated that some clinicians may be prescribing antiarrhythmics for ischemic or hypertensive heart disease, a practice for which there is no clear clinical trial evidence. According to the Miami Herald, 82 percent of all amiodarone prescriptions written in the US in the 12-month period ending July 31, 2003 were for atrial fibrillation and other off-label indications.

In October 2003, the FDA asked Wyeth to issue an advisory on amiodarone, concerning its toxicity and off-label use. But millions of prescriptions were filled before the drug company warned of its many risks and symptoms of fatal side effects.

In January 2005 the FDA and Wyeth finally sent out “Dear Doctor" and "Dear Pharmacist" letters notifying recipients that a new medication guide must be dispensed with every prescription for amiodarone hydrochloride (Cordarone and generic equivalents). The guide states that the most important information for patients is that "[ Cordarone] Tablets can cause serious side effects that can lead to death including:

• lung damage
• liver damage
• worse heartbeat problems"

Simvastatin

Simvastatin, a medication (statin) for lowering cholesterol, is often prescribed for treating coronary heart disease and reducing heart attack risk. In conjunction with amiodarone, simvastatin side effects include life-threatening rhabdomyolysis. Other side effects include:

• Muscle cramps and aches
• Joint pain
• Memory loss
• Insomnia
• Depression
• Anxiety
• Allergic reaction
• Breast development in boys (gynecomastia)
• Pancreatitis
• Hepatitis
• Worsening of cataracts
• Itchy skin
• Unexplained rash
• Eczema
• Impotence (also known as erectile dysfunction or ED)
• Increased liver enzymes
• Spinning sensation (vertigo).

The American Heart Association recommends that people who develop symptoms or signs of rhabdomyolysis (dark, cola-colored urine, usually with muscle aches, pain and weakness) should stop taking statin drugs in general and contact their health care provider immediately.

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