Crestor is used to treat high cholesterol. Some people who took the drug suffered severe side effects like kidney and liver damage, and type 2 diabetes.
Part of a hugely popular class of cholesterol-lowering drugs known as statins, Crestor sales have increased over time, reaching global sales of $6.6 billion in 2011. One survey shows that 22 percent of Americans older than 45 take a statin. Statins have been around since the late 1980s and bring in more than $20 billion annually.
Due to the prevalence of coronary artery disease and strokes — which are responsible for one in every three deaths in the United States — statins are a popular solution for people who cannot maintain their health with diet and exercise changes. Crestor and all statins are used to lower levels of cholesterol by inhibiting production of the enzyme in the liver that produces cholesterol. Most statins come with side effects that range from mild aches to severe muscle damage.
Unfortunately, Crestor also comes with a risk of serious side effects, including memory loss, type 2 diabetes, muscle pain, liver damage and a rare muscle condition called rhabdomyolysis that can lead to kidney failure and death. The Food and Drug Administration (FDA) has worked to address concerns about the side effects of Crestor by issuing alerts and updating warning information. Germany, Norway and Spain have not approved Crestor due to safety concerns.
Despite reports of adverse effects and lawsuits filed against AstraZeneca, the pharmaceutical company continues to profit from this dangerous drug.
Uses of Crestor
Crestor works by lowering bad cholesterol (Low Density Lipoprotein-C or LDL) and increasing good cholesterol (High Density Lipoprotein-C or HDL), which can prevent heart disease, decrease the need for heart surgery and reduce incidents of heart attacks and strokes. Crestor targets the breakdown of cholesterol in the liver by stopping an enzyme called HMG-CoA reductase, slows the progression of atherosclerosis (where arteries become blocked) and lowers triglycerides.
Doctors typically prescribe Crestor to men who are 50 or older and women who are 60 or older who have an elevated high-sensitivity C-reactive protein level of over 2 mg/L — which indicates inflammation — and one other cardiovascular risk factor such as high blood pressure, a family history of heart disease, smoking or low HDL. A blood test can measure the amount of cholesterol in the blood to indicate whether treatment is necessary.
The medication was originally approved for use in patients with bad cholesterol and a history of heart disease. In 2010, Crestor was approved for use in the prevention of heart attacks, strokes and death in people who are of fairly good health but have elevated C-reactive protein levels. However, by extending prescriptive use of Crestor to this population without existing heart problems, the FDA may have put millions of additional patients at risk.
Dosage varies from 5 to 40 mg, with higher reports of side effects for higher doses. Crestor should be taken at the lowest dose that offers therapeutic effects and should be combined with exercise and diet changes. Patients taking Crestor typically experience lowered cholesterol within a week and achieve maximum therapeutic response within a month; they remain on Crestor indefinitely.
Side Effects of Crestor
Crestor can cause minor side effects like heartburn, constipation, coughing and difficulty sleeping. Serious complications can also occur, including type 2 diabetes, myopathy (muscle pain), liver damage, rhabdomyolyis (tissue deterioration) and death. In one trial, people with one risk factor for diabetes who took Crestor were 28 percent more likely to develop type 2 diabetes than those taking a placebo. The study showed that even lower doses of Crestor, like 20 mg, increased the risk for diabetes. Other statins also have been associated with a risk for diabetes.
Liver damage is associated with Crestor use, and most patients must undergo liver enzyme tests before initiating treatment and 12 weeks later. Two cases of jaundice are reported in the FDA’s prescribing information for the medication. Patients with liver disease should not take this medication. The risk for liver damage may be increased by combining Crestor with other medications that lower cholesterol, such as fibrates or niacin.
Rhabdomyolyis is the most serious side effect of Crestor and can result in death. Rhabdomyolysis causes muscle fibers to break down and infiltrate the bloodstream, which can damage the kidneys and lead to kidney failure and death. In an article in the Canadian Medical Association Journal, eight post-clinical trial cases of rhabdomyolysis were reported; in some of these cases, people were taking doses as low as 10 mg.
Another statin, Cerivastatin, also caused rhabdomyolysis and was pulled from the market in August 2001 following reports of fatal rhabdomyolysis. The drug was linked to 52 deaths and many hospitalizations. The same year it was withdrawn from the market, it was estimated to bring in $16 million, showing that the statin world can be a high-profit, high-risk industry where hundreds or thousands may suffer before a drug is recalled.
Crestor, the FDA and a Recall Request
Since Crestor was released, the FDA has been forced to take action several times. In 2004, the FDA issued a public health advisory stating that Crestor increases the risk of muscle damage for users, with an increased risk for Asian populations.
Later in 2004, Sydney Wolfe, M.D., the director of Public Citizen, a nonprofit health advocacy group, sent a petition representing 160,000 consumers to the FDA requesting an immediate recall of Crestor to prevent additional cases of muscle damage and kidney damage. Public Citizen compared the dangers of Crestor to those of Cerivastatin and emphasized adverse events from trial data and public use.
The FDA responded to the petition in 2005, stating that the risk was not greater than that of other statins, but that Crestor’s label should be updated. In the same year, the FDA sent out an alert repeating the warning about muscle damage and highlighting the elevated risk for doses of 40 mg. The alert also stated that Crestor can lead to kidney failure. Following this alert, AstraZeneca added warning information to the package insert.
People experiencing serious side effects such as muscle damage, kidney or liver damage, type 2 diabetes, memory loss or rhabdomyolysis may look to file claims against AstraZeneca seeking compensation for medical costs, and pain and suffering. Taking a medication to control cholesterol can mean living with side effects that are life changing. Type 2 diabetes is a lifelong sentence, requiring close management of blood sugar. The kidney damage caused by rhabdomyolysis can be irreversible.
One group of patients filed a lawsuit over Crestor in May 2012 that included allegations associating the drug with sudden cardiac death. Another group filed a lawsuit in California in June 2012, claiming that AstraZeneca and its distributors marketed this dangerous drug even though it was known to cause injuries. And more people are exposed to these serious side effects every day, while AstraZeneca continues to profit.