Parker & Waichman, LLP Attorneys at Law CRESTOR Information Guide

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Neal Eaton
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Parker & Waichman, LLP Attorneys at Law CRESTOR Information Guide The Case Against CRESTOR: Kidney Problems & Rhabdomyolysis Crestor has been linked to serious side effects including: kidney damage,

1 Parker & Waichman, LLP Attorneys at Law CRESTOR Information Guide The Case Against CRESTOR: Kidney Problems & Rhabdomyolysis Crestor has been linked to serious side effects including: kidney damage, kidney failure and rhabdomyolysis. On October 22, 2004, the consumer group Public Citizen said twenty-nine patients who took AstraZeneca's cholesterol drug Crestor developed kidney damage. Manufacturer: Astra Zeneca Generic Name: Rosuvastatin Date Approved: August 8, 2003 Status: On the market Approved Uses: Cholesterol Serious Side Effects: Kidney damage Kidney failure Muscle damage Rhabdomyolysis Related Topics Baycol Rhabdomyolysis Statin Drugs Defective Drugs Diseases The consumer group Public Citizen has stated that the rate of reported kidney problems is approximately 75 times higher with Crestor than with all other drugs in the same class combined. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every 1 million Crestor prescriptions filled. Crestor has been linked to numerous cases of Rhabdomyolysis, a rare muscle destroying disease. Crestor is in the popular family of cholesterol-lowering drugs called Statins. Several years ago Baycol, another popular statin drug, was banned for its link to Rhabdomyolysis. Crestor Side Effects were Evident Before it was Approved Crestor was approved by the FDA in August 2003, after a delay because of safety concerns. During FDA studies seven cases of the potentially fatal, muscle-destroying condition Rhabdomyolysis occurred. These studies also linked Crestor with cases of kidney abnormalities not seen with other Statins. The FDA decided to approve Crestor but at lower dosages. However, records from the FDA and health agencies in Canada and Britain show life-threatening side effects occur even at those lower doses. Rhabdomyolysis is a serious disorder that causes kidney damage resulting from toxic effects of the contents of muscle cells. Myoglobin is an iron-containing pigment found in the skeletal muscle. When the skeletal muscle is damaged, the Myoglobin is released into the bloodstream. It is filtered out of the bloodstream by the kidneys. Myoglobin may obstruct the structures of the kidney, causing damage such as acute tubular necrosis or kidney failure. If you or a loved one took Crestor and suffered side effects, please fill out the form at the right for a free lawsuit case evaluation by a qualified drug side effects attorney.

Crestor (Rosuvastatin) Chemical Composition Rosuvastatin chemical structure Rosuvastatin is a member of the drug class of statins, used to treat hypercholesterolemia and related conditions, and to

Presentation Rosuvastatin is available as Crestor in tablet form (10, 20, or 40 mg) for oral administration.

2 Crestor (Rosuvastatin) Chemical Composition Rosuvastatin chemical structure Rosuvastatin is a member of the drug class of statins, used to treat hypercholesterolemia and related conditions, and to prevent cardiovascular disease. It is currently being marketed by the pharmaceutical company AstraZeneca as Crestor. Presentation Rosuvastatin is available as Crestor in tablet form (10, 20, or 40 mg) for oral administration. Tablets are pink, round or oval (40 mg), biconvex, film-coated, and imprinted with "ZD4522" and tablet strength. Japanese approval is in the dose range of 2.5 mg to 20 mg; therefore, smaller dose tablet forms might also be available outside the United States. Note that 97% of worldwide sales have been at or below the 20 mg dose. Mechanism of action Rosuvastatin is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of action similar to other statins. Indications and regulation Rosuvastatin is indicated for the treatment of elevated LDL cholesterol (dyslipidemia), total cholesterol (hypercholesterolemia) and/or triglycerides (hypertriglyceridemia). As of 2004, rosuvastatin had been approved in 67 countries and launched in 56. Approval in the United States by the FDA came on August 12, 2003.

3 Marketing & Competition The drug was billed as a super-statin during its clinical development, claimed to offer a high potency and improved cholesterol reduction compared to rivals in the class. Currently the main competition for Crestor is Vytorin by Merck & Co. (a combination of simvastatin (Zocor) and ezetimibe (Zetia)); unfortunately, there are no published studies showing which of the two drugs is more effective. First launched in 2003, sales were $129 million and $908 million in 2003 and 2004, respectively, with a total patient treatment population of >4 million by the end of Debate & Criticisms Several months after its introduction in Europe, Richard Horton, the editor of the medical journal The Lancet, criticised the way Crestor had been introduced. "AstraZeneca's tactics in marketing its cholesterol-lowering drug, rosuvastatin, raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines," according to his editorial. The Lancet's editorial position is that the data for Crestor s superiority relies too much on extrapolation from the lipid profile data and too little on hard clinical endpoints, which are available for other statins. The manufacturer responded by claiming that few drugs had been tested so successfully on so many patients. In correspondence published in The Lancet, AstraZeneca's CEO Sir Tom McKillop called the editorial "flawed and incorrect" and slammed the journal for making "such an outrageous critique of a serious, well-studied medicine." In 2004, the consumer interest organisation Public Citizen filed a Citizen's Petition with the FDA asking that Crestor be withdrawn from the US market. In 2005, the FDA, after a 14 month review of the specifics for each of the 35 individuals cited in the petition, formally denied this petition as not demonstrating any basis for additional concerns about rosuvastatin. Thirty two of the individuals had taken rosuvastatin at some time but the evidence was that their problems were most strongly related to other existing health issues and 3 of the 35 individuals had never taken rosuvastatin. Myopathy Some doctors have been hesitant to prescribe rosuvastatin because studies have suggested that this drug has a higher incidence of rhabdomyolysis (a severe undesired side effect) than other statins; this negative impact on sales performance has been much more pronounced in the United States than in other countries. The FDA has indicated that "it does not appear that the risk [of rhabdomyolysis] is greater with Crestor than with other marketed statins", but has mandated that a warning about this side effect, as well as a kidney toxicity warning, be added to the product label. [ Regarding myopathy and potential rhabdomyolysis, recent reviews of published data on all statins marked in the US, and reviewed by the FDA, have found that marked rises in the serum levels of muscle CK enzymes to 10 times normal or greater, the hallmark of serious

4 muscle problems, remain very rare, 1:10,000 to 1:20,000 individuals. Cerivastatin was an exception with a higher myopathy response. For the statins still on the market in the US, reported toxicity levels has been highest for pravastatin, simvastatin next, atorvastatin next and rosuvastatin the lowest at similar milligram doses. Yet the efficacy of these agents to change blood LDLipoproteins levels, at the same milligram doses, is the exact opposite. So, from the standpoint of the rare but serious muscle toxicity events, rosuvastatin, as of mid has turned out to have the best therapeutic index of the currently available statins. Renal Effects Regarding kidney function effects, recent reviews of published trial data, focusing on renal function, on placebo vs. statin, and tracking renal function over time have shown a small but distinct effect of statins to lessen renal dysfunction, when added to treatment (compared to placebo), and to slow the progression of further renal function decline over time. All the statins have a somewhat dose related response to increase urine protein levels, rosuvastatin the strongest association. Because increased urine protein has long been relied upon as a warning sign of renal glomerular dysfunction, this increase on statin treatment had been feared to indicate a negative effect on renal function. However, all current evidence is that the increase in urinary protein is from the renal tubular cells, not the glomeruli, and is due to cholesterol synthesis inhibition the tubular cells but is not associated with any decline in renal function. Instead, as mentioned above, clinical experience is that renal function, especially in those with partial renal failure, actually improves slightly and the rate of further decline decreases compared with those in the same trials who were randomized to the placebo agent. Comments, Changing Beliefs In general, experience with human responses to the statin agents has increasingly and dramatically driven a shift of conclusions toward the concept that much of common adult cholesterol production and blood transport behavior is unhealthy, even though cholesterol is an essential component of all human cell membranes. Though it is normal (i.e. common) for blood concentrations of LDLipoproteins to progressively rise with age as people get older, this is also strongly associated with development and progression of atherosclerotic plaque, typically not present as children under age 5 when cholesterol content of the blood LDLipoproteins is typically about 35 mg/dl. Scientists, physicians and the public continue to debate the issues and their varied and strongly held beliefs, yet clinical experience and research tracking of the benefits vs. risks has increasingly demonstrated realities contrary to the understanding and beliefs of many. Source Wikipedia.org

5 FDA Patient Information Sheet Crestor (Rosuvastatin Calcium) This is a summary of the most important information about Crestor. For details, talk to your healthcare professional. FDA ALERT: Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. To date, it does not appear that the risk is greater with Crestor than with other marketed statins. However, the labeling for Crestor is being revised to highlight important information on the safe use of Crestor to reduce the risk for serious muscle damage, especially at the highest approved dose of 40 mg. In addition, a study has found that the amount of drug in the blood of a diverse group of Asian patients taking Crestor was two times higher than for Caucasians patients in the study. Therefore, the labeling for Crestor will now recommend a lower starting dose of 5 mg for Asian patients. Kidney failure of various types has also been reported in patients treated with Crestor as well as other statins. FDA has determined that there is not enough evidence to conclude that kidney damage is a direct result of Crestor therapy. If you are currently taking Crestor or any statin and develop signs and symptoms of muscle pain and weakness, fever, dark urine, nausea or vomiting, you should contact your healthcare professional right away. This information reflects FDA s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available. What Is Crestor? Crestor is a medicine that lowers "bad" cholesterol and triglycerides and raises "good" cholesterol in the blood. Crestor is part of a treatment program that should also include a lowfat diet and exercise. Who Should Not Take Crestor? Do not take Crestor if you: Have liver problems or have persistently high liver enzymes Are pregnant or planning to become pregnant. Crestor may harm your unborn baby. If you get pregnant, stop Crestor and call your healthcare professional right away. Are breast-feeding. It is not known if Crestor can pass into your milk, and if it can harm your baby. You should choose to either take Crestor or breastfeed, but not both. Are allergic to Crestor or any of its ingredients Crestor has not been studied in children.

6 What Are The Risks? Crestor may cause rare, but serious, side effects including: Muscle damage. Crestor can cause serious muscle damage that can lead to kidney damage. The risk of muscle damage may be increased by taking certain drugs. Crestor should be used with caution if you have kidney problems, advanced age, and hypothyroidism because you are at a greater risk of muscle damage. Tell your healthcare professional if you develop unexplained muscle pain, tenderness, or weakness while on Crestor, particularly if accompanied by malaise or fever. Liver damage. Crestor can cause liver damage like other lipid lowering medicines. This risk may be increased when Crestor is used with certain medicines. Your healthcare professional may do blood tests to check your liver before you start taking Crestor, and while you take it. Crestor should be used with caution if you have a history of liver disease or drink substantial amounts of alcohol. Other side effects include muscle pain, constipation, weakness, abdominal pain, and nausea What Should I Tell My Healthcare Professional? Before starting Crestor, tell your healthcare professional about all your medical conditions, including if you: Are pregnant or planning to become pregnant Are breast-feeding Have liver problems Have kidney problems Drink alcohol Are There Any Interactions With Drugs Or Foods? Tell your healthcare professional about all the medicines you take, including prescription and over the counter drugs, and supplements. Crestor and certain medicines may interact with each other causing serious side effects. Crestor and other medicines may affect each other, causing serious side effects. Especially tell your healthcare professional if you take: Cyclosporine (Gengraf, Neoral, Sandimmune) Warfarin (Coumadin) Gemfibrozil (Lopid) Drugs that may decrease the levels or activity of your body s own steroid hormones. These drugs include ketoconazole (Nizoral), spironolactone (Aldactone), and cimetidine (Tagamet) Aluminum and magnesium hydroxide combination antacids (for example, Maalox)

7 How do I take Crestor? You should be placed on a standard lipid-lowering diet and an exercise routine before receiving Crestor and should continue these during treatment. Crestor can be taken as a single dose at any time of day, with or without food. The dose range for Crestor is 5 to 40 mg once daily. You should start on the lowest possible dose, and never start with 40 mg. After starting or changing your dose of Crestor, your lipid levels should be checked within 2 to 4 weeks and your dose adjusted as needed. Crestor FDA Approved 2003 Patient Information Sheet Revised 03/2005 If you or a loved one has been injured by Crestor, Parker & Waichman, LLP will evaluate your case for free. Click here for a free, no obligation, case evaluation.

Crestor and thyroid problems

Crestor and thyroid problems Recently it has been observed that many people on statins have been referred for special radioiodine studies because they have been found to have low to no thyroid stimulating hormone (TSH) in their blood