Cholesterol is a naturally occurring substance in the human body and people need it to live. However, too much cholesterol is bad for ones health as the excess is absorbed and collected in the body's arteries and it can cause heart disease. High cholesterol affects millions of Americans and is becoming a burgeoning and all too common problem in today's society. Causes of high cholesterol range from family genetics, to lifestyle choices such as a diet high in saturated fats (mainly animal products including fatty meat and dairy products) to not getting enough physical exercise. Regardless of the origin of high cholesterol, it has become very important to treat this growing problem.

As such, many prescription cholesterol-lowering drugs have been released into the market that claim to, in combination with a healthier diet and over-all life-style, or when diet and exercise alone are not enough, help lower a patient's cholesterol level.

One of these new drugs is Crestor (rosuvastatin calcium). Crestor was initially developed by the Japanese pharmaceutical company Shionogi and was in-licensed to Astra-Zeneca, an international pharmaceutical company, in April 1998. The FDA approved Crestor in August 2003. Multiple clinical studies have confirmed the effectiveness of Crestor in reducing LDL-C ('bad' cholesterol) and raising HDL-C ('good' cholesterol). Crestor is now treating over 4.5 million patients worldwide.

Crestor belongs to a family of drugs called Statins. Statins combat cholesterol by blocking a specific enzyme in the body that synthesizes cholesterol. All Statins are accompanied by a higher risk of a dangerous and potentially fatal condition called Rhabdomyolysis, but Crestor is particularly closely associated with it. The FDA recalled another popular cholesterol-lowering drug containing statins due to reports of severe Rhabdomyolysis.

Rhabdomyolysis is a condition that causes the breakdown of different muscle fibers, which then causes the broken-down muscle contents to release toxic cells into the blood stream. In very rare instances, Rhabdomyolysis may result in kidney damage and other organ damage that can be fatal.

Symptoms of Rhabdomyolysis include

• Muscle pain, weakness and/or tenderness.
• General feeling of sickness or malaise.
• Fever.
• Dark urine.
• Nausea.
• Vomiting.

The pain may involve specific groups of muscles or may be generalized throughout the body. Additional serious side effects associated with Crestor include flu like symptoms, yellowing of the skin or eyes, unexplained fatigue and pale colored stools. These may be early symptoms of muscle or liver problems, or acute kidney failure and/or kidney damage.

Due to the adverse side effects associated with Crestor and all Statin-containing drugs, the FDA has revised the labeling and package insert for Crestor. The new labeling highlights the importance of safe use of Crestor to reduce the risk of serious muscle toxicity.

Additionally, revisions have been made to inform patients of the results of a study involving a diverse population of Asian patients compared with a Caucasian control group. The study found that Rosuvastatin, the active ingredient in Crestor, drug levels in the Asian participants were elevated approximately two-fold compared to the Caucasians. Due to these findings, the label advocates a lower starting dosage of 5mg for Asian patients. Additionally, the "Warnings" and "Dosage and Administration" sections of the label have been revised to include more emphasis on the risks of Myopathy, especially at the highest approved dose of 40 mg.

The FDA is continuing to monitor all Statin-containing drugs.