AstraZeneca's Crestor lowers cholesterol and prevents strokes and heart attacks, but has also been linked to serious side effects like type 2 diabetes and liver damage.
Liver damage has occurred in some users, so Crestor should not be taken by anyone with a history of liver disease. Instances of muscle pain often accompany statin use and can be minor or develop into rhabdomyolysis, which is a serious condition that damages kidneys and sometimes results in death.
Taken once daily, Crestor doses range from 5 mg to 40 mg and are prescribed to men and women over 50 with heart disease risk factors or evidence of inflammation in their arteries. People taking higher doses experience a greater risk of side effects like muscle pain.
|Common side effects of Crestor include:|
Confusion, Special Populations and Pregnancy
In the Justification for the Use of statins in Prevention: an Intervention Trial Evaluation (JUPITER) study completed in 2008, confusion was present in 0.2 percent of Crestor users, compared with 0.1 percent of placebo subjects. Additional instances of confusion — some with memory loss — also have been reported in Crestor use.
AstraZeneca warns that there is an increased risk of side effects for Asian populations. In clinical studies, Crestor was more potent for Asian subjects compared with Caucasian subjects, increasing the risk of developing negative side effects. Because of this, doctors typically begin at doses of 5 mg for this population.
Crestor is contraindicated for pregnant women. The Food and Drug Administration (FDA) labels Crestor with the pregnancy category X, which means there is evidence that the drug can harm a human fetus., Women who are or may become pregnant should not take Crestor. Because the medication is primarily used by older patients, this is not typically a concern.
Liver problems can develop during the first three months of treatment, so patients should undergo liver enzyme tests before treatment begins and again 12 weeks later. Two cases of jaundice occurred during clinical tests of Crestor. The FDA prescribing information, which was updated in 2012, reports rare events of fatal and non-fatal liver failure in Crestor patients. Patients with a history of liver disease or those who consume large amounts of alcohol should approach this medication with caution.
|Symptoms of liver function abnormalities include:|
|Upper belly pain||Dark urine|
|Yellowing of skin or whites of eyes|
Type 2 Diabetes
A 2008 Crestor study examined 18,000 people and found an elevated risk for type 2 diabetes with statin use. Another study, published in 2010, revealed that the risk of diabetes increased by 9 percent for those taking statins. The 2010 study found evidence of people taking doses as low as 20 mg developing diabetes. Doctors hypothesize that the association between Crestor and diabetes may be due to the medicine increasing muscle resistance to insulin.
Type 2 diabetes occurs when the body either stops producing enough insulin or becomes unable to properly use insulin. This results in high blood sugar and can lead to complications such as eye problems, numb feet, heart disease and kidney disease.
|Early symptoms of type 2 diabetes include:|
|Slow-healing or frequent infections||Fatigue|
|Increased thirst||Increased urination|
Patients using statins may already be susceptible to kidney problems due to pre-existing conditions that go along with having high cholesterol, such as diabetes, atherosclerosis, hypertension and heart failure. Public Citizen, a nonprofit health advocacy group, states that there were 29 instances of kidney failure or problems within the first year after Crestor was approved. Unfortunately, because pre-existing conditions may exist, it is difficult to determine whether renal failure reported by patients taking Crestor was caused by the medication.
In trials for Crestor, some users developed proteinuria (protein in the urine). In some of these instances, blood was also present in the urine. However, damage to the kidneys was not detected in these cases. If there is continued evidence of proteinuria, the causes should be investigated. Crestor is also associated with kidney damage relating to muscle problems.
Another very serious side effect of Crestor is myopathy, a muscle condition that causes weakness and pain. There have been rare reports of muscle tissue breaking down, which is known as rhabdomyolysis. Rhabdomyolyosis is a condition where damaged muscle cells can infiltrate the blood stream and harm the kidneys, leading to kidney failure.
The FDA reports that creatine kinase levels (which are a marker of heart attack, severe muscle breakdown or renal failure) were higher in 0.2 to 0.4 percent of Crestor patients than in placebo groups. At doses of 40 mg or higher, more instances of muscle problems have been reported. In extremely rare cases, rhabdomyolysis can be fatal.
In 2005, the FDA issued a health advisory on Crestor, informing the public of the incidences of rhabdomyolysis and the necessity of prescribing the drug at the lowest effective dosage to minimize risks.
|Signs of rhabdomyolysis that should be addressed before the kidneys are irreversibly damaged include:|
People with risk factors such as sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders, or seizures are advised to approach this medication with caution. The risk of muscle problems increases in people 65 years or older and in those with thyroid or kidney problems. Cholesterol-lowering drugs that may increase the risk of liver damage when taken in conjunction with Crestor include fibrates, niacin, gemfibrozil, cyclosporine and lopinavir.