More than 102 million people in the United States have high cholesterol1, which increases the risk of heart disease and stroke. That is why people were hopeful when the cholesterol-lowering drug Crestor was approved by the U.S. Food and Drug Administration.
Although countless people took Crestor to lead healthier lives and drugmaker AstraZeneca made billions of dollars, Crestor was not as safe as patients believed. In the following years, more and more serious side effects were linked to the cholesterol medication.
Patients have fought back against the makers and distributors of Crestor by filing lawsuits with claims that they knew about the risks associated with the drug but failed to warn consumers. They also allege AstraZeneca promoted Crestor in false or misleading ways.
What is Crestor?
Crestor is the brand name for the drug rosuvastatin. Used in conjunction with proper diet, exercise, and weight-loss, Crestor is designed to help treat high cholesterol and prevent heart disease.
Crestor is a member of the drug class called statins or HMG-CoA reductase inhibitors.It functions by blocking enzymes in the liver to help prevent the organ from making too much cholesterol. It also works by increasing the uptake and breakdown of cholesterol already in the blood.
The ultimate goal of the drug is to lower the bad LDL cholesterol and slow plaque buildup in the arteries.
History of Crestor
The drug was developed by the Japanese pharmaceutical company Shionogi in the late 1990s. In 1998, drugmaker AstraZeneca licensed the rights of Crestor and submitted applications for approval in markets around the world.
The Netherlands was first to approve Crestor for the treatment of primary hypercholesterolemia and mixed dyslipidemia in 2002. In August the following year, the FDA granted drugmaker AstraZeneca approval for Crestor.
Even before approval for the U.S. market, the drug was poised to rival existing statins. In the early days, Crestor was nicknamed the “gorilla statin” and the “super statin” after early trials showed better efficacy and similar safety profile to statins on the market.
However, safety concerns delayed the drug’s approval in some European countries, including four that didn’t get approval until 2008. The drug was later approved for the prevention of heart disease by the FDA in 2010.
To say Crestor was a success is an understatement. The drug quickly became one of the best-selling drugs in the United States. Some estimates say that Crestor brought in global sales of $6.6 billion for AstraZeneca in 2011.
Before 2016, Crestor brought in more than $50 billion in sales for AstraZeneca.
Crestor Generics Approved by FDA in 2016
The success of Crestor started waning in 2016 after the patent for the drug expired. This means other drugmakers were allowed to make generic versions of rosuvastatin sold under different names. Generic drugs are often significantly cheaper and boast the same quality and strength as name-brand counterparts.
The FDA approved the first generic version of Crestor made by Watson Pharmaceuticals in April 2016.
“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” the FDA’s Kathleen Uhl said at the time2. “The FDA requires that generic drugs meet rigorous scientific and quality standards.”
Within months, several other generic versions of the drug were approved by the FDA, driving down the profits and overall use of Crestor.
Most Common Crestor Side Effects
AstraZeneca warns the most common side effects3 include:
- Muscle aches and pains
- Abdominal pain
Crestor Linked to Several Serious Side Effects
Even before the FDA had approved Crestor in 2003, concerns about the safety of the drug lingered. The problems associated with Crestor only grew in the following years as studies and reports confirmed links between the drug and dangerous side effects.
This is just a partial list of the serious side effects linked to Crestor.
Rhabdomyolysis is a rare but serious muscle disorder that can lead to kidney damage, paralysis, and even death. Reports indicated that patients taking Crestor were at a much greater risk of developing the disorder than patients taking other statins.
According to a postmarketing analysis published in the journal Circulation4 in 2005, Crestor was significantly more likely to be associated with rhabdomyolysis, proteinuria, nephropathy, or renal failure.
Damage to the kidney is not uncommon among statins. However, concerns over Crestor’s rate of kidney damage appeared within the first year of its approval in the United States. An analysis of adverse events reported to the FDA revealed high rates of kidney damage.
An organization called Public Citizen5 found 29 reports of kidney failure or insufficiency in Crestor patients. It was about 75 times the rate of kidney failure compared to all the other statins combined. As a result of the finding, the group called for a recall of Crestor in 2004 over safety concerns. The FDA denied the request but added warnings to the labels.
Liver damage also became a concern for Crestor users. The drug can raise the levels of a liver enzyme that causes liver injuries. In 2012, the FDA approved label changes6 to all statins reflecting the risk of liver damage.
Type 2 Diabetes
The connection to type 2 diabetes was made when a 2008 study7 found a 27 percent increased risk of developing diabetes in patients taking Crestor. That number jumped up to 48 percent for women taking Crestor.
In rare instances, cases of memory loss and confusion have been reported among Crestor users. One study8 suggested that those who took statins and other cholesterol medications were more likely to report memory loss within 30 days of starting treatment. The label for Crestor says memory loss and confusion are possible side effects.
Hundreds File Crestor Lawsuits Against AstraZeneca
With all the reports of serious and sometimes fatal side effects mounting, patients started taking action against AstraZeneca. Hundreds of people filed lawsuits against AstraZeneca over a variety of claims.
Here are some of the most common claims against the company:
- Knew or should have known of risks
- Engaged in false or deceptive marketing of Crestor
- Failed to properly test the safety of Crestor
- Concealed information about the safety of the drug
- Failed to warn users of dangers
- Designed defective or dangerous product
At one point, there were more than a thousand lawsuits filed in California. About half of the cases were dismissed over jurisdiction.
Countless people who have been harmed by the serious side effects of Crestor are still pursuing legal action against AstraZeneca. Due to claims that the pharmaceutical company may have known about the risks for years but did nothing, plaintiffs may have a stronger case.
Those who can show they were harmed as a direct result of Crestor and AstraZeneca’s negligence may be eligible for compensation.