Crestor

What Is Crestor?

Crestor is a prescription drug used to treat and prevent stroke, heart disease, and heart attacks. It was approved by the U.S. Food and Drug Administration (FDA) in 2003 and became one of the top 15 best-selling drugs of all time with lifetime sales of over $60 billion.

Crestor’s active ingredient is rosuvastatin, a member of the “statin” group of drugs which work by inhibiting enzyme HMG-CoA reductase that is used in creation of cholesterol. Crestor helps to reduce the amount low density lipoprotein-C, or LDL cholesterol in the blood stream. LDL is often referred to as the “bad” cholesterol, as it can build up inside the arteries, resulting in obstruction of blood that flows to the brain, heart, and elsewhere in the body.

Crestor also works to increase levels of high density lipoprotein-C, or HDL cholesterol, known as “good” cholesterol. This type of cholesterol can help prevent heart disease, heart attacks, and stroke. HDL is also believed to decrease a patient’s need for heart surgery. AstraZeneca claims that Crestor can lower LDL cholesterol by as much as 52 percent and also works to lower triglycerides, another type of fat in the blood stream.

Crestor is the second best-selling anti-cholesterol medication used in the U.S. and while it has helped many patients stay heart-healthy, it has also caused deadly side effects. Many people who took Crestor and experienced severe side effects have filed Crestor lawsuits against AstraZeneca to seek compensation for their injuries.

Statin Use

Crestor is a member of the drug class known as statins. Statins work to slow cholesterol production in the body and reduce cholesterol buildup within artery walls which may decrease the risk for heart attack and stroke.

One in every three U.S. deaths is caused by heart disease or stroke. High cholesterol is thought to be a major risk factor for cardiovascular disease. Though newer medications have been approved to treat high cholesterol levels, statins have not fallen in use. Research shows that 28 percent of Americans, age 40 and older, take a statin to regulate their cholesterol levels.

Side Effects

While Crestor has helped many people control their cholesterol levels, side effects can be bothersome, severe, or even life-threatening. Among the range of Crestor side effects, patients can develop type 2 diabetes, liver damage, and kidney failure. When taken during pregnancy, Crestor side effects can cause severe birth defects to developing embryos.

Common Crestor Side Effects

As with many other prescription drugs, users have reported a number of minor Crestor side effects. Crestor is prescribed as a once-daily pill. Doses can be given from 5 to 40 milligrams per day. Qualifying Crestor patients are over age 50 and exhibit risk factors for heart disease. Evidence of artery inflammation is also a risk factor that warrants a prescription. Reports suggest that those who take higher doses are more likely to experience Crestor side effects.

Common Crestor side effects include:

• Nausea
• Headache
• Constipation
• Weakness
• Muscle aches
• Insomnia
• Heartburn
• Abdominal pain

Crestor and Pregnancy

Crestor side effects can be severe for children born to pregnant Crestor patients. For this reason, it is strongly recommended not to take Crestor if patients are pregnant or may become pregnant. The U.S. Food and Drug Administration (FDA) assigns a pregnancy category for drugs that may cause birth defects. The FDA has assigned Crestor to pregnancy category X meaning that evidence strongly suggests that Crestor may affect an unborn fetus or cause harm during pregnancy.

Crestor Liver Complications

Crestor may result in changes in liver function and in some cases, may cause liver failure. Liver problems are most common during a patient’s first three months taking Crestor. It is recommended that doctors perform liver enzyme testing before patients begin a Crestor regimen. Liver enzyme testing should also be performed 12 weeks after treatment begins. Liver enzyme monitoring can help reduce the instance of Crestor side effects in the liver.

In 2012, prescribing information for Crestor was updated to include reports of liver failure. These reports warned against rare Crestor side effects causing fatal and non-fatal liver complications. Patients who drink alcohol heavily should take caution when considering Crestor treatment.

Crestor side effects of the liver may cause the following symptoms:

• Weakness
• Dark-colored urine
• Uncharacteristic tiredness
• Pain in the upper belly area
• Jaundice, or yellowing of the eyes and skin

Crestor Kidney Complications

Crestor may cause kidney damage or changes to kidney function. This may be life-threatening in some, severe cases where rhabdomyolysis has occurred. Kidney problems can be exacerbated in patients with high cholesterol who may experience other conditions such as hypertension, diabetes, and atherosclerosis. These conditions can contribute to Crestor side effects in the kidneys. The existence of these conditions prior to Crestor treatment can make it difficult to determine if Crestor directly contributed to the patient’s kidney problems.

Crestor Muscle Complications

Complications of Crestor use may occur, particularly when the medication is used at a dose of 40mg/day or more. Crestor use may cause myopathy which results in muscle weakness. Additionally, a rare disease called rhabdomyolysis can occur if myopathy becomes severe and results in breakdown of muscle tissue. While some muscle tissue breakdown is natural, excessive breakdown caused by Crestor may occur suddenly and can lead to kidney damage or failure and may be life-threatening.

Crestor Rhabdomyolysis

Rhabdomyolysis is a rare but potentially fatal disease. It causes excessive damage to the body’s muscles. Normally, when muscles break down, they release fiber contents called myoglobin into the bloodstream. The kidney then filters myoglobin from the blood.

During rhabdomyolysis, a large quantity of muscle fibers and cells begin to break down. This breakdown or lysis of muscle cells results in sudden flooding of the kidney with protein and other cellular contents which may overwhelm kidney function. In addition to the flooding of the kidneys with excessive myoglobin, when metabolized myoglobin releases additional substances that can cause kidney damage. In severe cases, kidney failure and death can occur.

Crestor Type 2 Diabetes

Research shows evidence that Crestor may increase the risk for developing Type 2
Diabetes. A 2010 study revealed that patients who took statins for their cholesterol had a 9 percent higher risk of developing type 2 diabetes. When one additional risk factor such as obesity was present, the risk may be as much as 48% higher in people who took Crestor.

Type 2 diabetes is characterized by an insufficient amount of insulin or an inability to use insulin properly and some evidence may suggest that Crestor increases insulin resistance in muscle tissue.

Crestor side effects indicating early type 2 diabetes include:

• Extreme fatigue
• Unusual weight loss
• Frequent thirst
• Frequent urination
• Increased infections
• Cuts or bruises that heal slowly
• Numbness or tingling in the limbs

Crestor Cardiomyopathy

Crestor is also associated with cardiomyopathy. Cardiomyopathy is the deterioration of the myocardium, or heart muscle which may be similar to increased muscle breakdown caused by Crestor. Patients who suffer cardiomyopathy experience an increased risk of arrhythmia, or irregular heartbeat. Cardiomyopathy can lead to heart failure and death.

Crestor Lawsuits

Multiple lawsuits have been filed against AstraZeneca for harm caused to Crestor patients, including type 2 diabetes, heart attacks, and cardiomyopathy. These lawsuits have alleged that AstraZeneca concealed the dangers of using Crestor. AstraZeneca was accused of knowing about the deadly side effects but continuing to market the defective drug anyway. These claims assert that AstraZeneca failed to publish study results that showed the dangers of Crestor.

Additionally, plaintiffs alleged that AstraZeneca used deceptive practices and misleading statements to market Crestor. These marketing messages failed to adequately warn consumers of the severity or Crestor side effects.

Crestor Lawsuit Claims

In 2004, the U.S. Food and Drug Administration ruled that Crestor ads contained false or misleading claims when marketing materials compared the drug to other statins. The FDA asked AstraZeneca to stop running advertising with misleading claims but rejected a petition filed by consumer protection group, Public Citizen, which had filed to recall Crestor.

In 2012, a group of plaintiffs filed a state court Crestor lawsuit against AstraZeneca in California. The lawsuits also named Crestor distributor, McKesson Corporation as a plaintiff and cited injuries including diabetes, rhabdomyolysis, and liver damage.

The Crestor lawsuit patients alleged that Crestor was designed, produced, distributed, and marketed despite the defendants’ knowledge that Crestor was dangerous and defective. This claim essentially means that the manufacturers willfully endangered its users by failing to make the drug safer and failing to give consumers a more thorough warning of the dangers associated with its use.

The California filings numbered more than 1,200, however up to 1,000 of these lawsuits were filed by out-of-state residents and the cases were dismissed. Between 2012 and 2013, a number of lawsuits were also filed in Tel Aviv, Israel, however the plaintiffs withdrew from the action in 2016.

AstraZeneca Federal Lawsuit

In April 2010, AstraZeneca agreed to pay $520 million as a settlement for federal investigations of illegal marketing practices of its schizophrenia drug Seroquel. AstraZeneca allegedly paid kickbacks to physicians as an incentive for marketing Seroquel for unapproved uses. AstraZeneca is accused of promoting Seroquel to the elderly, prisoners, veterans, and children. While doctors are permitted to prescribe medications for off-label uses, pharmaceutical companies are prohibited from marketing them for off-label uses that have not been specifically approved by the FDA.

Additionally, AstraZeneca was accused of misleading patients and doctors by emphasizing research that favored Seroquel. At the same time, the company failed to adequately warn the public of the increased risk of developing diabetes while using Seroquel. As a result of these allegations of deception, AstraZeneca faced more than 25,000 civil suits from injured Seroquel patients who claim that they were not properly warned of the risks.

Crestor Lawsuit Settlements

In 2018, the Texas Attorney General announced a settlement with AstraZeneca to resolve “false and misleading marketing schemes” over marketing of Crestor and Seroquel. The settlement was based on a whistleblower lawsuit which had been filed by four former AstraZeneca employees in Texas and Delaware.

The company was accused of promoting Crestor for unapproved uses and defrauding Medicaid. Though the U.S. government declined to prosecute the case, the State of Texas joined the lawsuit. The Delaware portion was dismissed, and AstraZeneca denied the Texas allegations but agreed to a $110 million settlement.

In February of 2018, AstraZeneca stated in a financial report that it had resolved all product liability claims, though no terms were disclosed.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.