Crestor Frequently Asked Questions

What is Crestor?

Crestor (rosuvastatin calcium) is a prescription strength synthetic lipid-lowering agent manufactured and marketed by AstraZeneca U.S. It belongs to a class of drugs called HMG-CoA reductase inhibitors (statins) that are designed to lower the bad cholesterol (LDL) and triglycerides (TG) levels in the blood stream. The active ingredient in Crestor is Rosuvastatin calcium, and the inactive ingredients are: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF. Crestor can be taken as a single dose at any time of day with or without food. However, taking it with food does decrease the absorption. The FDA-approved tablet doses for oral administration are 5, 10, 20, and 40 mg. The 80 mg dosage was not approved.

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What is Crestor used for?

Crestor is used as an adjunct to a low-cholesterol diet and exercise program Crestor is thought to reduce elevated total Cholesterol (total-C), Low-Density Lipoprotein Cholesterol (LDL-C), apolipoprotein B (ApoB)-a membrane complex for LDL-C-and non-HDL-C cholesterol levels, as well triglyceride (TG) levels. It also tends to increase High-Density Lipoprotein Cholesterol (HDL-C) (good cholesterol) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Type IIa and IIb). Additionally, as an adjunct to diet, Crestor is used for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); and to reduce LDL-C, total-C, and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Source: Official Crestor site (www.astrazeneca-us.com) created and maintained by its manufacturer, AstraZeneca U.S.

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How does Crestor work?

There are two types of cholesterol: LDL and HDL. Doctors call HDL the "Good Cholesterol" because your body needs it. Conversely, LDL is considered to be the "Bad Cholesterol" because high levels of LDL cholesterol are associated with conditions such as heart attack and stroke. Think of your liver as a cholesterol factory. It creates cholesterol at night while you are sleeping. Crestor works directly in the liver, inhibiting the enzyme that manufactures the bad cholesterol (LDL) while leaving the production of HDL alone. By inhibiting or blocking the action of this liver enzyme, your body's ability to produce LDL (bad) cholesterol is dramatically reduced. However, while Crestor does lower LDL (bad) cholesterol, it has a limited effect on HDL (good) cholesterol, and no effect on triglycerides (fats), an equally dangerous heart disease risk indicator.

AstraZeneca Pharmaceuticals, LP (the Crestor drug manufacturer) recommends that liver function tests be performed before someone begins Crestor therapy and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. In most cases, people with vastly elevated liver enzymes should stop taking Crestor immediately.

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Is Crestor right for you?

Do not take Crestor if you:

  • have certain liver problems;
  • are pregnant or planning to become pregnant. Crestor may harm your unborn baby. If you get pregnant, stop Crestor and call your healthcare provider 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 breast feed, but not both.
  • are allergic to Crestor or any of its ingredients.

Crestor has not been studied in children.

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I'm trying to get pregnant, can I take Crestor?

No. Pregnant, breastfeeding, or women trying to get pregnant should not be taking any kind of cholesterol lowering drugs because statins may cause birth defects.

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What should I tell my health care provider before taking Crestor?

Before starting Crestor, tell your health care provider about all medical conditions, including if you:

  • are pregnant or planning to become pregnant;
  • are breast-feeding;
  • have liver problems;
  • have kidney problems;
  • drink alcohol.

Also, be sure to tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Crestor and certain medicines may interact with each other causing serious side effects. Crestor and certain medicines may affect how each other work.

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What other drugs affect Crestor?

Do not take Crestor if you are taking:

  • the blood thinner Coumadin;
  • Cyclosporine, a medicine with multiple uses, including use after organ transplants or for rheumatoid arthritis and psoriasis;
  • Certain types of other medicines that lower cholesterol;
  • Antacids.

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What are some possible side effects of Crestor?

Like all medicines, Crestor may cause side effects in some people. These side effects are usually mild to moderate and usually go away after a short time. The most common side effects are:

  • muscle pain;
  • constipation;
  • weakness;
  • abdominal pain;
  • nausea.

Crestor may cause serious, but rare side effects including:

  • Muscle damage. Crestor can cause serious muscle damage that can lead to kidney damage.
  • Liver damage. Crestor can cause liver damage. This risk may be increased when Crestor is used with certain medicines. Your doctor may do blood tests to check your liver before you start taking Crestor, and while you take it.

This is NOT a complete list of side effects reported with Crestor. Your health care provider or pharmacist can discuss with you a more complete list of side effects. For more detailed information about Crestor, ask your health care provider or pharmacist.

If you develop any unexplained muscle pain, tenderness, or weakness at any time during treatment with Crestor (especially if you also have a fever or feel ill), call your doctor right away.

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What is the recent news on Crestor all about?

In March of 2004, the activist group Public Citizen complained to the US Food and Drug Administration (FDA) that a condition called rhabdomyolysis was occurring more frequently with Crestor than with other statins.

Rhabdomyolysis is a serious condition that involves muscle damage and affects the kidneys. This condition is known to be a very rare side effect of all currently marketed statins, the class of cholesterol medication that includes Crestor. In medical circles, "very rare" is defined as occurring in fewer than 1 in 10,000 cases.

As with all other currently marketed statins, the rate of rhabdomyolysis with Crestor is very rare-less than 1 in 10,000.

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Why are news organizations still covering something that happened months ago?

In June, Public Citizen's Sidney Wolf repeated his old charges from March against Crestor in the British medical journal The Lancet, despite the fact that the FDA has continued to say that Crestor is safe when prescribed appropriately.

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What is the problem with Crestor?

The problem is that the FDA approved Crestor even though it has been proven more problematic than other kinds of cholesterol lowering statins.

There are currently six statin drugs on the market:

  1. Lipitor (atorvastatin)
  2. Lescol (fluvastatin)
  3. Mevacor (lovastatin)
  4. Pravachol (pravastatin)
  5. Zocor (simvastatin)
  6. Crestor (rosuvastatin)

A seventh statin, cerivastatin (Baycol) was removed from the market in 2001 because of adverse reactions and serious side effects, including rhabdomyolysis.

Statins work by reducing production of cholesterol in the liver and by increasing the ability of the liver to remove LDL (bad) cholesterol from the blood. Statins reduce the level of LDL cholesterol in the blood and can reduce triglyceride levels and increase levels of HDL (good) cholesterol.

As the newest statin, Crestor has been marketed as a "super-statin" because AstraZeneca claims it reduces LDL cholesterol to a greater degree than the other approved statin drugs.

The approval of Crestor is controversial because it follows the recall of Bayer's Baycol which was also a super-statin. In 2001, Baycol was removed from the market because it caused life threatening side effects like rhabdomyolysis, a fatal muscle disorder. Side effects were reported with Crestor that appeared reminiscent of the Baycol experience. Cases of rhabdomyolysis were seen with Crestor during drug trials, particularly with the 80 mg. dose.

Crestor was approved by the FDA in August 2003 for the 5, 10, 20, and 40 mg doses, but not the 80 mg dosage. In recent months there have been reports of serious side effects resulting from use of Crestor, such as:

The FDA already has records of seven patients with rhabdomyolysis, including a 39-year-old American who died after using a 20-mg dose and a second death from an unspecified country, four patients with acute kidney failure, including a 79-year-old American man who died, plus five additional patients with kidney damage. Crestor interacted dangerously with the blood-thinner Coumadin, commonly used by heart-disease patients; one Crestor-Coumadin interaction resulted in a hemorrhage. Some studies show that only one-tenth of the actual cases are reported to the FDA.

The fact that so few patients on the 20 or 40 mg. doses took the drug for a sufficient period of time to have had a chance to develop rhabdomyolysis seems to have imparted a false sense of security about the safety of these doses concerning muscle toxicity. It is certainly possible that the FDA will require that Crestor be removed from the market after further damage to patients occur.

Rhabdomyolysis is a potentially fatal condition where serious muscle damage occurs. Those who have taken Crestor should immediately consult their doctors.

Symptoms of rhabdomyolysis include:

  • muscle pain;
  • muscle weakness;
  • fever;
  • fatigue;
  • nausea;
  • vomiting;
  • dark urine

Although rhabdomyolysis generally results in muscle pain, the condition can exist even in patients who experience no pain.

This condition causes muscle protein and myoglobin to be released into the blood stream and cam damage the kidneys, resulting in the failure of the organ.

Rhabdomyolysis can be diagnosed through blood tests. If you or a loved one has used Crestor, promptly consult your doctor for an evaluation.

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Someone I know was just switched off of Crestor-should I stop taking mine?

Your doctor knows your complete medical history and considered your individual needs in deciding that you need medical treatment to lower your cholesterol and that Crestor is the appropriate medication for you.

High cholesterol is a chronic condition with potentially serious health consequences. It cannot be cured, but it can be managed successfully. Ongoing treatment is necessary to keep it under control. Crestor, together with a healthy diet and regular exercise, can be a highly effective combination in cholesterol management. Do not discontinue medications without consulting your doctor.

As with all currently marketed statins, if you develop any unexplained muscle pain, tenderness, or weakness, at any time during treatment (especially if you also have a fever or feel ill), tell your doctor right away, as they may be signs of serious side effects. Be sure to tell your doctor about other medications you are taking. If you have any concerns about taking Crestor, please contact your doctor to discuss them.

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How do I know if I'm one of the people at risk for rhabdomyolysis?

Your doctor took your complete medical history into consideration when he or she prescribed a statin. However, you should talk to your doctor if you have any concerns about this issue. The people who are at increased risk for this very rare but serious side effect when taking a statin include those with:

  • Advanced age (65 years or older);
  • Low thyroid hormone levels (hypothyroidism);
  • Kidney disease.

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Is there any truth to the report of a death from rhabdomyolysis while using Crestor?

There have been no reported deaths due to rhabdomyolysis in patients taking Crestor.

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Is it still safe for me to take Crestor?

If your doctor has decided that Crestor is right for you, he or she has weighed the risks associated with high cholesterol against the potential for side effects associated with all statins.

It is important to remain on your medication and to discuss any concerns you have with your doctor. When taking any statin, if you develop any unexplained muscle pain, tenderness, or weakness at any time during treatment (especially if you also have a fever or feel ill), tell your doctor right away, as they may be signs of a serious side effect.

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Is this a similar situation to what happened with Baycol® (cerivastatin), the cholesterol drug that was withdrawn from the market?

No. Baycol was associated with a high number of deaths due to rhabdomyolysis (more than 30). For this reason, the drug was withdrawn from the market. In contrast, there are no reported cases of death due to rhabdomyolysis with Crestor in the over 3 million patients worldwide who have used Crestor since launch.

The U.S. Consumer group Public Citizen has submitted a petition to the FDA recommending that Crestor be removed from the pharmaceutical marketplace. This comes after twenty-nine patients who had taken AstraZeneca Plc's drug Crestor developed kidney damage. The rate of reported kidney problems is approximately 75 times higher than with competing drugs within the same class of statins.

Crestor (rosuvastatin calcium) is a cholesterol reducing drug and part of a class of pharmaceuticals called "statins." Statins reduce cholesterol by reducing a specific enzyme responsible for the synthesis of Cholesterol in the body.

Statins have been associated with rare occurrences of Rhabdomyolysis, but significantly more occurrences have been reported that are associated with the use of Crestor. 65 cases of Rhabdomyolysis have been reported to the FDA so far, which is similar to the rate associated with Baycol.

The FDA Endrocrinologic and Metabolic Drugs Advisory Committee opposed the approval of Crestor because of its unique kidney toxicity. Because of the safety concerns, the maximum dose strength was reduced from 80 mg to 40 mg.

BAYCOL® is a registered trademark of Bayer Corporation.

CRESTOR® is a registered trademark of the AstraZeneca group of companies.

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What are the grounds for a Crestor law suit?

If you have developed rhabdomyolysis, kidney damage, myoglobinuria, drug-induced hepatitis or a family member has died from acute renal failure (ARF) or any of the above that could potentially be linked with your regular use of Crestor, you may want to consider a Crestor law suit. As with all cases of negligence and product liability, it is important that you consult an attorney regarding filing a Crestor law suit, in order to obtain compensation. Click any of the panels on the left and right sides of this page to contact a Crestor lawyer now.

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Is there a time limit to file a Crestor side-effect law suit?

Yes. Every state has a different statue of limitations with some being as short as one year. To determine if you or a family member have a Crestor side-effect lawsuit, please consult an attorney.

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What firms handle Crestor law suits?

The likelihood of a successful Crestor law suit varies based on the facts of each case. However, the sheer number of different legal firms offering their services specifically to victims wanting to file Crestor law suits is an indication of the significance of this subject, and the belief that there is a basis for recovery. The circumstances of each person's use of the drug will differ and may determine the outcome of any Crestor law suit brought by them. There are also local issues, involving specific state laws, which may alter the treatment of each Crestor suit.

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Who are the Crestor law suits filed against?

Grounds for legal proceedings lie almost solely with AstraZeneca. This is most likely where the Crestor law suit would be directed.

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Should I contact the manufacturer AstraZeneca about my Crestor side-effect symptoms?

You should contact your doctor and have your doctor file an adverse reaction report with the FDA. You should also consider contacting an expert Crestor attorney to discuss your legal rights. We do not recommend contacting AstraZeneca directly, since you may be eligible for a Crestor side-effect lawsuit.

You should also call the FDA MedWatch at 1-800-FDA-1088.

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