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Simvastatin and Amiodarone

Simvastatin Side Effects, US FDA Contraindications, Lawsuits

Simvastatin and Amiodarone Side Effects May Lead To Rhabdomyolysis Lawsuits

Simvastatin and Amiodarone | Lawsuits, Lawyers | Side Effects: Rhabdomyolysis, Kidney Damage, Kidney Failure, Muscle Diseases, Severe Muscle Injuries, Seizures

Read about the latest Zocor FDA Warning about Muscle Injury

If you or a loved one have been taking Simvastatin/Zocor and are experiencing myopathy(muscle injury after taking the 80mg dose of simvastatin, you have valuable legal rights that the personal injury law firm Parker Waichman LLP wants to protect. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our experienced lawyers specializing in simvastatin and other defective drugs as soon as possible.

The lawyers and attorneys at Parker Waichman LLP, a national personal injury law firm, are offering free case evaluations to individuals injured because they took a combination of the drugs simvastatin and amiodarone. Since 2002, the Food & Drug Administration (FDA) has twice warned that taking simvastatin with amiodarone could cause a potentially fatal muscle disease called rhabdomyolysis. If you or someone you know has developed rhabdomyolysis following treatment with these drugs, we urge you to contact one of our simvastatin and amiodarone injury lawyers as soon as possible.

Simvastatin is a statin that is used to lower cholesterol Simvastatin is an ingredient in Merck & Co's Zocor and Abbott Laboratories Inc's Simcor, and is sold generically. It is also a component of Merck and Schering-Plough Corp's Vytorin. Amiodarone is anti- medicine, and is an ingredient in Wyeth's Cordarone and is also sold generically.

All statins already carry a risk of rhabdomyolysis. However, the FDA has said that the risk of developing rhabdomyolysis is more pronounced when simvastatin is combined with amiodarone than it is with other statin medications. Despite the fact that the FDA first warned of this problem in 2002, simvastatin and amiodarone are still being prescribed together. Since the original warning, dozens of patients have developed rhabdomyolysis as a result of taking these drugs. Our simvastatin and amiodarone injury lawyers have determined that the makers of these medications have failed to adequately warn patients and doctors about their potential to cause rhabdomyolysis when taken together.

Rhabdomyolysis causes the rapid breakdown of skeletal muscle tissue. The destruction of the muscle leads to the release of the breakdown products of damaged muscle cells into the bloodstream. Some of these, such as myoglobin, are harmful to the kidney and may lead to acute kidney failure, and even death. Our simvastatin and amiodarone injury lawyers know how devastating a diagnosis of rhabdomyolysis can be, and are committed to insuring that victims of these drugs are fairly compensated for their injuries.

Rhabdomyolysis results from any condition that causes significant muscle damage. These include: certain muscle diseases; severe muscle injuries (e.g., crush injury); overuse of alcohol or illicit drugs; use of some prescription drugs (especially statins line simvastatin); and severe seizures or convulsions.

Some of the most common symptoms of rhabdomyolysis are:

  • dark, red, or cola colored urine color
  • muscle tenderness
  • weakness of the affected muscle(s)
  • generalized weakness
  • muscle stiffness or aching
  • unintentional weight gain
  • seizures
  • joint pain
  • fatigue

Rhabdomyolysis is treatable and patients may recover quickly if the disease is caught in its early stages. However, if left untreated, acute kidney failure develops in 30-40 percent of patients. Early and aggressive hydration may prevent complications from rhabdomyolysis by rapidly eliminating the myoglobin from the kidneys. This may involve intravenous administration of several liters of fluid until the condition stabilizes. Diuretics such as mannitol or furosemide may aid in flushing the myoglobin out of the kidneys. If the patient produces sufficient urine a doctor may administer bicarbonate, which can prevent the myoglobin from breaking down into toxic compounds within the kidney. In the most severe cases of rhabdomyolysis, a patient may have to undergo dialysis.

Simvastatin, Amiodarone and Rhabdomyolysis

In 2002, the FDA issued its first warning about the risk of rhabdomyolysis when simvastatin was taken with amiodarone. But in August 2008, the FDA was compelled to issue a second warning. The agency said the new warning was necessary because it continued to receive reports of the muscle disease in patients taking both simvastatin and amiodarone. In fact, between the original 2002 warning and 2008, the FDA said 52 more patients had developed rhabdomyolysis while taking simvastatin and amiodarone.

According to the 2008 FDA warning, the risk of developing rhabdomyolysis is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. The agency said that healthcare professionals who prescribe simvastatin or simvastatin-containing medications (Simcor, Zocor, Vytorin) should be aware that patients taking amiodarone should not take more than 20 mg per day of simvastatin.

Patients starting therapy with simvastatin, or who have had their dose of simvastatin increased, should contact their doctor immediately if they  experience symptoms of unexplained muscle injury, such as muscle cramps, pain, tenderness, stiffness or spasm.

The FDA said it is working with the manufacturer of Cordarone (amiodarone) to modify prescribing information to warn of an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses exceeding 20 mg daily. In 2002, the labeling of simvastatin was changed to include similar information.

Legal Help for Victims of Simvastatin and Amiodarone

If you or a loved one were diagnosed with rhabdomyolysis after taking simvastatin along with amiodarone, you have valuable legal rights. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our experienced simvastatin and amiodarone injury lawyers as soon as possible.


Simvastatin and AmiodaroneRSS Feed

Citing Muscle Risks, FDA Restricts Highest Zocor Dose

Jun 9, 2011 | Parker Waichman LLP
Patients taking the statin Zocor Should Not Be Given The Highest 80 mg Patients taking the statin Zocor (simvastatin) should not be given the highest 80 mg dose in their first year of treatment, according to the U.S. Food & Drug Administration (FDA).  The agency's review of a clinical trial, as well as an analysis of its adverse even reports prove that such patients face the highest risk of suffering myopathy (severe muscle injury), including it's most severe form,...

FDA Says High Dose of Zocor Linked to Serious Muscle Injury

Mar 19, 2010 | Parker Waichman LLP
Federal regulators warned today against taking the highest approved dose - 80 mg - of the statin Zocor (simvastatin).  According to the  Food & Drug Administration (FDA) the high dose has been associated with a higher risk of serious muscle injury, called myopathy, and a disorder called rhabdomyolysis. The agency’s warning was based on its review of data from a large clinical trial called the Study of the Effectiveness of Additional Reductions in Cholesterol and...

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