The new cholesterol-lowering drug Livalo (generic: pitavastatin) has recently been linked to serious side effects including muscle damage, myopathy, rhabdomyolysis, kidney failure, type 2 diabetes and death. Based on the severity of these complications, a number of consumer advocacy groups have argued that Livalo and other similar stain drugs should be removed from the market. At Schmidt & Clark, LLP, our Defective Drug Lawyers understand that your injuries may not be your fault – instead, they may possibly be a dangerous side effect of Livalo.

Livalo Overview

First approved by the U.S. Food & Drug Administration (FDA) in August 2009, Livalo is a widely-prescribed HMG-CoA reductase inhibitor or “statin” drug. Statins like Livalo are designed to lower cholesterol by reducing the activity of an enzyme in the liver that is necessary for the production of cholesterol. Lowering cholesterol levels may help prevent heart disease and hardening of the arteries, conditions that can lead to heart attacks, strokes, and vascular disease.

In addition to Livalo, other FDA-approved cholesterol-lowering drugs from the statin class include:

• Zocor
• Lescol
• Crestor
• Vytorin
• Simcard
• Simcor
• Simlup
• Simvacor
• Lipitor
• Mevacor
• Altoprev
• Pravachol
• Advicor

Side Effects of Livalo

Despite its considerable effectiveness at treating high cholesterol, Livalo and other drugs from the statin class have been increasingly linked to the following serious side effects:

• muscle damage
• myopathy
• kidney damage
• kidney failure (also known as renal failure)
• rhabdomyolysis
• diabetes
• death

Livalo & Muscle Injuries

Statin drugs like Livalo have long been known to cause muscle pains and inflammation around the muscle cells (myositis). This risk is increased when a statin is combined with other drugs that may cause muscle damage, such as niacin, Lopid (gemfibrozil) or Tricor (fenofibrate). Signs and symptoms of Livalo-induced muscle damage may include:

• muscle weakness
• cramps
• stiffness
• tetany (involuntary contraction of the muscles)

Livalo & Rhabdomyolysis

Rhabdomyolysis is a severe form of muscle damage that occurs when skeletal muscles die following an injury. When muscle cells are injured, they break down and release substances such as potassium, phosphate, creatinine kinase, and myoglobin into the bloodstream. When excessive amounts of these substances buildup in the blood, it can be harmful to the heart. Telltale symptoms of rhabdomyolysis may include:

• a dark or tea-colored urine
• blood in the urine
• passing too little or no urine at all
• bruising of muscles
• fast heartbeats
• mental confusion
• easy irritation
• nausea (feeling sick to the stomach)
• vomiting (throwing up)
• trouble breathing

Livalo Kidney Damage

According to a 2010 study published in the British Medical Journal (BMJ), statin medications like Livalo can significantly increase a user’s risk of developing long-term kidney damage. Researchers from Nottingham University in the United Kingdom analyzed data on more than two million patients between the ages of 30 and 84 who had been taking statin drugs for an extended period of time. The study confirmed prior research suggesting that statins increase patients’ risk of kidney damage, finding that for every 10,000 patients treated with the drugs, approximately 23 would develop acute renal failure. Symptoms of kidney injuries caused by Livalo may include:

• vomiting
• nausea
• weight loss
• nocturnal urination
• more or less frequent urination habits
• itching
• bone damage
• muscle cramps
• abnormal heart rhythms
• muscle paralysis
• swelling of the legs, ankles, feet or hands
• dizziness
• low blood pressure