Don't Take Crestor For Cholesterol ~ DVT - Living With Deep Vein Thrombosis

Wednesday, March 19, 2008

Don't Take Crestor For Cholesterol

As the readers know I have DVT, A High Likelihood of Pulmonary Embolisms, and High Cholesterol

My dad mentioned that taking statins can hurt your kidneys this is what I found so far:

NEWSLETTER 11: BAD CRESTOR

Crestor Rhabdomyolysis

Rhabdomyolysis is a life-threatening muscle deterioration that is associated with statin type of cholesterol lowering medication like Crestor. AstraZeneca's NDA (new drug application) with the FDA for Crestor was initially delayed when the company halted clinical trials worldwide after reports of kidney damage, death and muscle weakness (an early signal for rhabdomyolysis) in clinical trials in patients taking 80 milligrams of Crestor per day. Crestor labeling includes warnings about the potential for muscle and kidney problems, including rhabdomyolysis, but warning labels arguably may not be adequate and sufficient enough to convey the seriousness of the severe side effects that can occur from Crestor use. Crestor is the only statin that is known to have caused rhabdomyolysis in pre-approval clinical trials. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria [a protein from muscle] have been reported with rosuvastatin and with other drugs in this class. The professional product labeling goes on to instruct physicians to tell patients "... to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever." The risk of muscle damage leading to rhabdomyolysis during treatment with rosuvastatin may be increased when it is used together with other cholesterol-lowering drugs and cyclosporine (NEORAL, SANDIMMUNE), a drug used after transplantation to prevent organ rejection. A single rosuvastatin dose given to healthy volunteers along with the cholesterol-lowering drug gemfibrozil (LOPID) resulted in a significant increase in the amount of rosuvastatin in the body. There is a bolded statement in the Warnings section of rosuvastatin's labeling stating that "Combination therapy with rosuvastatin and gemfibrozil should generally be avoided." The risk of muscle problems possibly leading to rhabdomyolysis is also increased when niacin is used to lower cholesterol in combination with rosuvastatin. Crestor, a member of a class of cholesterol-lowering drugs commonly referred to as "statins", was approved in the U.S. in August 2003, and based on review of an extensive clinical database involving approximately 12,000 patients. "Myopathy/Rhabdomyolysis" increased risk in: increased age, hypothyroidism; renal insufficiency. Physicians are warned to prescribe Crestor with caution in these patients, particularly at higher doses, as the risk of myopathy increases with higher drug levels. In addition, the U.S. approved labeling for Crestor states that increased rosuvastatin drug levels were observed in certain sub-populations of patients (ie: subgroups of Asians, patients concomitantly using cyclosporine and gemfibrozil), conferring increased risk of myopathy. Because of these findings, the FDA required Astra-Zeneca to make available in the U.S. a 5-mg dose that could be used in patients requiring less aggressive cholesterol-lowering, or who were taking concurrent cyclosporine. The maximum recommended dose in the FDA-approved label is limited to 10-mg daily in patients with severe renal impairment or who are also taking gemfibrozil. To date, seven patients using Crestor (rosuvastatin) are known to have developed a deteriorative muscle condition known as rhabdomyolysis, and nine others have suffered kidney damage or failure. Even the death of a 39 year old woman isn't enough for the FDA to ban Crestor.

Some people claim that Crestor has dangerous side effects such as proteinuria (protein in the urine) and rhabdomyolysis, (a dangerous condition where the muscles break down and release toxic chemicals into the bloodstream that hurt the kidneys). For Crestor, there were about 13 reports of rhabdomyolysis for every million prescriptions filled, Public Citizen estimated. That rate was 6.2 times higher than the rates for all other statins combined.

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