Crestor has been hugely popular for people with high cholesterol, but it has been implicated in some serious complications that have led to a number of lawsuits against maker AstraZeneca. Crestor is indicated for the treatment of high cholesterol and was first approved by the U.S. Food and Drug Administration (FDA) in 2003.
AstraZeneca pushed hard to market their new drug in the early 2000s, but wasn’t long before the dangerous side effects of Crestor became known. In addition to some less serious side effects, Crestor is now linked to liver damage and a devastating condition called rhabdomyolysis. The risks are serious enough that the FDA has issued warnings about it and several lawsuits have been started against AstraZeneca by those patients who suffered because of taking it.
What is Crestor?
Crestor is a drug in the class called statins, which are used to lower high blood cholesterol levels. Having too much cholesterol is dangerous because it can lead to cardiovascular diseases that are ultimately fatal. These include atherosclerosis, heart disease, and even strokes. Statins improve cholesterol levels by lowering so-called bad cholesterol, raising the levels of the good kind, and reducing the amount of triglycerides in the blood.
The generic name for Crestor, which was developed by AstraZeneca, is rosuvastatin. It is supposed to be used along with healthy lifestyle changes. Rosuvastatin and other statins work by targeting an enzyme in the body that plays a big role in producing cholesterol. Blocking the enzyme and its action both slows down the production of cholesterol and aids in removing existing cholesterol from blood vessels.
AstraZeneca claims that Crestor can lower cholesterol levels by up to 52 percent, but this positive outcome doesn’t come without a steep cost for some people. It is not uncommon for patients taking the drug to experience memory loss, confusion, depression, headaches, dizziness, insomnia, constipation, stomach pains and other gastrointestinal issues, and achy joints.
Crestor and Liver Damage
The common side effects of the medication are not usually serious, but there are more serious possible complications, including damage to the liver. The problem was known to some extent when Crestor first came out in 2003 and so the label has always included a warning about liver damage. However, since then, more serious and damaging effects have been experienced by some patients and anyone with existing liver damage or a history of liver disease is not supposed to take the drug.
The problem is that Crestor increases the production of certain enzymes in the liver, especially when taken in larger doses. In rare cases this can lead to serious damage to the liver and even hepatitis. These issues are most often seen in someone who has been on the drug for at least two to four months. It may be rare, but the problem is serious enough that the FDA recommends all patients be screened for liver problems before taking Crestor.
The Risk of Rhabdomyolysis
There is another rare, but also serious and even deadly possible consequence of using Crestor and this has led to many of the Crestor lawsuits against AstraZeneca. Some patients have developed a condition called rhabdomyolysis while taking the drug. This is characterized by unusual breakdown of muscle tissue, which can cause muscle and joint pain, weakness, fatigue, and overall achiness.
People with this condition may even have seizures and experience unexplained weight gain. If rhabdomyolysis is left untreated the broken down muscle tissue can wreak havoc on the kidneys. Kidney damage and eventually failure are the ultimate end of this condition, which means death if it is not caught and treated. It is this terrible illness, and many cases of kidney damage, that has led to a number of Crestor lawsuits.
Misleading Marketing
In addition to the real risks of taking Crestor, AstraZeneca has come under legal fire for misleading the public about the safety and effectiveness of the drug. In 2004, there were already concerns about the safety of Crestor when the drug company ran ads firing back against claims that it could cause serious health problems.
The main criticisms came in the form of a letter published in the medical journal The Lancet. The author cited some of the pre-approval clinical data that had not been published before and that showed more clearly how serious the risk of rhabdomyolysis is. In the advertisements used to counteract this criticism AstraZeneca claimed that the FDA confirmed the safety and effectiveness of Crestor.
This statement was misleading, and actually downright false. The ads prompted a warning letter from the FDA. It reprimanded AstraZeneca not just for making false claims about its drug, but also for misrepresenting the FDA, what it has said about Crestor, and for misleading the public about the FDA and the drug.
The FDA also warned the company that it misrepresented the risks of the 40-milligram dose of Crestor. In the ads the company claimed that Crestor lowered bad cholesterol levels better than other statins. This may be true only for the 40-milligram dose, which carries a higher risk of complications than the 20-milligram dose that most patients take. No lawsuits have arisen from the advertising scandal.
Lawsuits
While AstraZeneca’s punishment for misleading advertising ended with a warning letter, the real individuals affected by Crestor have fired back at the company with lawsuits. Several suits are pending and many people who have been hurt by the drug are awaiting an outcome that will provide them with some measure of compensation. Most of these suits focus on the kidney damage caused by rhabdomyolysis.
Those filing the lawsuits claim that AstraZeneca did not adequately warn them of the serious risks of taking Crestor, such as liver damage and kidney damage. They also claim that the company is negligent because it knew about these risks and did not communicate them, and in fact actively marketed the drug with the intention of increasing sales. Whistleblowers, as published in The Lancet letter, have already proven that AstraZeneca knew about the possibility of rhabdomyolysis and all its complications. This means that those filing a lawsuit may have a real case to make against the company and how it acted with Crestor.
If you took Crestor and you suffered any of the more serious side effects of the drug, like kidney damage, you too may have a case against AstraZeneca. Complications like those caused by Crestor can be painful and expensive and have far-reaching consequences like losing work and harming relationships. To take your life back, compensation helps. Talk to a lawyer who knows about pharmaceutical lawsuits and find out how you can get started on seeking that compensation.
Sources
- http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2804%2916513-6/fulltext
- http://meps.ahrq.gov/mepsweb/data_files/publications/st205/stat205.pdf
- http://query.nytimes.com/gst/abstract.html?res=9B02E1DE1130F930A15751C1A9629C8B63
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21366slr005lbl.pdf
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC450358/