Crestor, known generically as rosuvastatin, is used along with diet and exercise to lower high cholesterol. It was approved in the US in August 2003 and is in a class of drugs known as statins.
In October 2012, the FDA announced a change to Crestor's warning label, alerting patients to the risk of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy that is associated with statin use. Symptoms of IMNM include proximal muscle weakness and increased serum creatine kinase, both of which can continue after treatment with Crestor has stopped. The FDA notes that this side effect is rare.
In March 2012, the FDA announced a label change to statin drugs including Crestor. The label was changed to alert patients to the risk of side effects and possible drug interactions linked to statin use. The FDA noted there were reports of muscle injury when statins were used with fibrates (cholesterol-lowering drugs), niacin (in large doses), Ranexa (used to treat angina), or Colchicine (used to treat gout).
At the time, the agency further noted that there were reports of rare but serious liver problems in patients who use statins. Symptoms of liver problems include tiredness or weakness, loss of appetite, upper belly pain, and dark-colored urine. Some patients have also experienced an increase in blood sugar levels.
In 2005, Astra-Zeneca Pharmaceuticals changed Crestor's label to reflect the risk of serious muscle toxicity (myopathy/rhabdomyolysis). Although premarketing trials indicated a risk of muscle damagea side effect seen in other statinsthe updated label reflected data from studies indicating that Asian people could be at an increased risk of muscle damage. The new label recommended that Asian patients be started on the 5 mg dose.
According to the FDA, Crestor is associated with a low incidence of rhabdomyolysis (severe muscle damage). The FDA also noted that various forms of kidney failure were reported in patients taking Crestor.
A letter from Public Citizen to the FDA, suggests that the risk of rhabdomyolysis is higher in Crestor than in other statin drugs. According to the letter, written by Sidney Wolfe, then director of Public Citizen's Health Research Group (03/10/05), the risk of rhabdomyolysis linked to Crestor is 6.2 times higher than the rate of all other statins combined. Furthermore, when comparing Crestor to the statin with the lowest rate of rhabdomyolysis, the risk in Crestor is 21.8 times higher.
So far, the FDA has denied Public Citizen's petitions to have Crestor banned.
Rhabdomyolysis is a serious condition in which the muscle fibers are broken down and their contents, called myoglobin, are released into the blood stream. Myoglobin can cause kidney damage.
Some statins have reportedly been linked to an increased risk of cardiomyopathy, a serious weakening of the heart muscle or a change in the structure of the heart muscle. Cardiomyopathy is associated with the heart's inability to pump blood adequately and other problems related to the function of the heart.
Statins and Cardiomyopathy
On February 28, 2012, the FDA announced that use of statins was associated with an increased risk of diabetes mellitus. Although the FDA said the risk is small, some critics argue that studies investigated by the FDA included statins that were not as potent as others. For every 167 people taking Crestor, for example, one person developed diabetes. That's compared with one in every 255 patients treated with a statin overall.
The JUPITER study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) found that in certain patients, the risk for newly developed diabetes increased 25 percent in patients who used Crestor over those who were given a placebo. Meanwhile, a meta-analysis of six statin studies showed the risk of new-onset diabetes increased by about 13 percent when patients were given a statin.
The FDA has not removed Crestor from the market, saying it believes the benefits of statin drugs continue to outweigh the risks.
Women who are pregnant are cautioned against using statins because of the risk of adverse effects on the fetus.
Statins and Birth Defects
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