When the US Food and Drug Administration (FDA) approves a new drug they generally pour over research to find make sure they don’t have an embarrassing Vioxx experience (the drug ended up killing patients and had to be pulled from the market causing huge embarrassment to the FDA). Crestor (rosuvastatin) is what’s called a “statin” (a cholesterol reducing drug) and the FDA needs not look far for another embarrassing bungle in the statin catagory, a drug called Baycol, which was also linked to a few deaths before being yanked from pharmacist’s shelves.
You see, often the research provided to the FDA is paid for and produced by scientists working for the company that produces the drug and is looking for its approval. In Crestor’s case the company is pharmaceutical giant AstraZeneca, a company that seems to have a lot of sway with the FDA.
Essentially, they appealed to the American in each of the FDA officials that approved it with the logic that bigger is better, or in Crestor’s case, more is better. The standard starting dose of Crestor is 10 mg, which reduces LDL-C (bad cholesterol) a whopping 46%-52%. Some people, especially those with serious coronary disease, require this degree of LDL-C reduction, but most people with elevated cholesterol require only 20% to 30% reductions.
As in most things in life, moderation is likely the better route to take. AstraZeneca has exceeded the “Point of Diminishing Returns” (the point where the drug reaches its peak of benefits and any dosage after just starts compounding the side effects) in relation to all other statins in order to differentiate Crestor from the rest of the market. In this article you will see that this behavior is to the potential harm of the patients taking the drug.
Crestor (Rosuvastatin) Side Effects
There are some common side effects associated with statins in general.
General side effects for most statins are:
- Muscle Pain
- Liver Damage
- Digestive Problems
- Rashes and Blemishes
Crestor was put through clinical trials and as is the standard scientific procedure, was compared to placebo (sugar pills). As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the group not taking the medicine. The problem with some of these studies is that not all side effects are captured within studies and sometimes they are avoided (the study is discontinued early or the findings are not presented by the company) because they could make a drug unmarketable.
The placebo study found:
- Muscle Pain (12.7%)
- Joint Pain (10.1%)
- Headache (8.5%)
- Nausea (6.3%)
- Constipation (4.7%)
- Body Weakness – Asthenia (4.7%)
- Dizziness (4%)
- Abdominal Pain (2.4%)
You might have noticed the number one side effect on both lists is Muscle Pain. The reason for this is that almost all statins run the risk of causing a deadly muscle disease called Rhabdomyolysis.
Crestor and Rhabdomyolysis
Rhabdomyolysis is a disease that causes the cells of muscles deplete throughout the body. This can occur in a certain muscles or all over the body, the later being the case with statins. When the whole body is affected, it leads to serious complications in the probably the most important muscle in the body, the heart.
Crestor is a drug that’s sole purpose is to help the heart and prevent arterial buildup that can lead to heart disease and heart attacks. Yet, with such a large dose of rosuvastatin, essentially the largest on the market, this can seriously weaken the heart muscle and ultimately lead to a similar result, thus trading one problem for another.
In a research study done by independent watchdog group, Public Citizen, they poured over prescription data as compared to other statins and came up with some surprising conclusions.
They found that the rate of reports of rhabdomyolysis sent to the FDA per million prescriptions filled for Crestor (13.1 reports p/mil pres.) is 6.2x higher than the rate for all of the other statins combined (2.1 reports p/mil pres.). The comparison between Crestor and the statin with the lowest rate of rhabdomyolysis reports (Pravachol, 0.6 reports p/mil pres.) shows Crestor to have a rate 21.8x higher than this statin. Even compared to the rate of the statin having the second highest rate of reports (Zocor/simvastatin), Crestor is 2.8x higher.
Lets quantify that. When they are talking about comparing Crestor with other competitors and they beat them out by almost 22x more patients, not 22 patients, not 22% of patients, 22 times. Even at almost 3 times higher than their nearest competitor, when one speaks about the millions of prescriptions, that means that at the very least, 30,000 more patients are effected by rhabdomyolysis than the rest of statins on the market.
Crestor Attorneys
Crestor’s increased risk of rhabdomyolysis is not the only stunning result that the Public Citizen review found. They also cited the findings of another study that resulted in an increased risk of kidney failure (renal failure).
“The new data comparisons–showing a uniquely higher rate of this life-threatening adverse effect for Crestor than for other statins–need to be considered in conjunction with our earlier analysis showing that the rate of acute renal failure reports in people not having rhabdomyolysis was 75 times higher for Crestor than for the other statins combined,” the report said.
Both of these increased chance of side effects prompted the independent non-profit organization to write a letter to the FDA in 2004 requesting that the government agency recall the drug from the market due to serious damage to patients. The FDA responded the next year refusing the request.
Since then Crestor has gone on to be approved in 56 other markets and is currently filling millions of prescriptions per year without warning it customers of the real deadly side effects of the drug.
If you or your loved one has had a cardio-event or kidney failure while taking Crestor, it is very important that you find legal council that is experienced in defective drug litigation so that you can get the compensation you deserve. Call Phillips Webster for a free consultation.
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