Date approved: 2003
Status: Prescription only
Approved uses: Statin drug used for lowering cholesterol.
Off-Label uses: N/A
• Serious Muscle Toxicity (Myopathy)
• Musculoskeletal Symptoms
• Kidney Damage
Crestor Lawsuit Information
Crestor is a member of the cholesterol-lowering family of drugs called statins. Crestor has been documented to have a severe, sometimes fatal side effect, rhabdomyolysis. Rhabdomyolysis is characterized by muscle cell deterioration and the release of those cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. Fatal Crestor rhabdomyolysis is more prevalent when Crestor is taken in higher doses. Liver damage is also a possible side effect of Crestor and other lipid-lowering statin drugs.
Consumer Groups Ask FDA to Remove Crestor from the Market
In August 2003, the Federal Food and Drug Administration (FDA) approved Crestor, manufactured by AstraZeneca. Crestor belongs to a family of drugs called statins. The active ingredient, rosuvastatin, is in a class of medications called HMG-CoA reductase inhibitors – statins. Crestor became the sixth cholesterol-lowering statin drug on the market, following the drugs Lipitor, Pravachol and Zocor. These drugs combat cholesterol by blocking a specific enzyme in the body that synthesizes cholesterol. Between 2003 and 2006, Crestor was prescribed approximately 22 million times to more than 4.7 million patients.
Less than four months after Crestor’s FDA approval, three U.S. patients who were taking approved doses of rosuvastatin developed Crestor-related serious side effects. These side effects included kidney failure and/or muscle damage. As with Baycol, another cholesterol-lowering medicine withdrawn from the market by Bayer Healthcare due to its serious side effects in August 2002, the muscle damage, known as rhabdomyolysis, deteriorates the kidneys.
In 2004 and 2005, several consumer groups asked the FDA to recall Crestor partially because of the reported serious complications within five months of the drug’s initial approval. These groups cited the patients who developed kidney failure and/or muscle damage while taking approved doses of Crestor. The groups also noted that in studies that were conducted before Crestor’s approval, seven people became ill with rhabdomyolysis.
In March 2004, Public Citizen (another consumer group) complained to the FDA about the negative effects of Crestor and asked that the drug be removed from the market. The FDA contended that Crestor’s risks were no greater than those of its competitors, and rejected the consumer efforts to remove the drug from the market. However, in May 2005, the American Heart Association’s journal, Circulation, published a report confirming the complaints of Public Citizen. The report suggested that users of Crestor were up to six times more likely to suffer complications, as compared to users of other statins. AstraZeneca has not removed Crestor from the market and continues to stand behind the safety and effectiveness of the medication as long as the product is used according to the prescribing information.
According to some reports, to date the FDA has received over 65 reports of rhabdomyolysis and 29 cases of acute renal failure or renal insufficiency out of 4.5 million Crestor prescriptions. This is similar to the rate associated with Baycol. That medicine was removed from the market after 31 reported cases of fatal rhabdomyolysis, none of which were identified before FDA approval.
In March 2005, the FDA issued a public Health Alert for Crestor stating the following:
“Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. To date, it does not appear that the risk is greater with Crestor than with other marketed statins. However, the labeling for Crestor is in the process of being revised to highlight important information on the safe use of Crestor to reduce the risks for serious muscle toxicity especially at the highest approved dose of 40 mg.”
The FDA stated that the labeling was also being revised to reflect the results of a large pharmacokinetic study involving a diverse population of Asian patients compared with a Caucasian control group. This study found drug levels to be elevated at approximately twice the rate in Asian patients. Kidney failure rates of various types were also reported in the Asian patients treated with Crestor and other statins.
Patients who are candidates for statin therapy (patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may be at higher risk for kidney failure even when they are not taking statins. Additionally, the FDA has not been able to conclude that recommended doses of Crestor can cause or exacerbate renal failure as reported by some studies and patients.
The FDA approved the revisions to the Crestor prescribing information shortly after the public Health Advisory in 2005. The changes strengthened the language around the appropriate use of Crestor. At the same time, the FDA issued a statement that confirmed that the potential benefits of Crestor currently outweigh the potential risks when the drug is taken as directed. This does not mean that the potential for serious side effects does not exist.
Any individual that believes they may have been harmed or suffered adverse heath effects from the usage of Crestor should seek the advice of an attorney who specializes in pharmaceutical litigation.
FDA Issues Warnings For Crestor Side Effects
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.
• Dark urine.
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.