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AstraZeneca, a biopharmaceutical company focused on improving the health and wellness of millions of people around the world by developing innovative medications, has been forced to pay $13 billion in fines for failing to warn its patients about potential health risks.

AstraZeneca failed to alert the U. S. Food and Drug Administration and the European Medicines Agency about the company's controversial prescription drug Crestor, a cholesterol-lowering medication that can cause serious liver damage and other side effects. It also failed to warn the public about the drug's safety and the risks of taking the drug, and the company was required to disclose the risk to consumers in an FDA-issued drug warning letter.

The U. Food and Drug Administration's warning letters to AstraZeneca raised concerns about the safety and efficacy of Crestor in people with serious liver disease, according to the company's official response.

The FDA had previously required AstraZeneca to make a statement acknowledging that patients taking the medication, which contains the drug, were at a significantly higher risk of having an increased risk of liver failure than those who took the drug alone.

AstraZeneca's response to the FDA letter was to include a statement that stated, "We understand that you have a number of potential side effects with this medication. If you experience any of these symptoms, speak to your doctor."

In addition to the FDA letter, the company's other response included a statement that said, "We would be happy to provide more information about the potential risks and side effects associated with Crestor."

The company also failed to provide information about the risks of using Crestor in people with a known hypersensitivity to any of its components. The company did not explain why patients taking the drug, which contains the drug, should not receive a heart attack warning.

AstraZeneca's failure to provide information about the risks and side effects of Crestor in people with a known hypersensitivity to its components led to the company's withdrawal from the drug in March 2007, the company announced on January 3, 2008. The company's withdrawal from the drug was the result of the company's failure to alert the FDA about the drug's risks.

The company said it would continue to follow the company's advice and would not update its information about Crestor's safety or the side effects it caused, including its statement that "the FDA has not provided any information to us about the potential risks and side effects of Crestor."

In the letter to AstraZeneca, the company's letter to the FDA stated that the company's withdrawal from the drug was "not the result of any of the drug's known side effects."

AstraZeneca has been accused of failing to warn consumers about the risks of taking Crestor, the company's "common" cholesterol-lowering medication, and to warn the public about its potential side effects.

The company said in a statement that it "is not aware of any of these risks or side effects."

AstraZeneca has been accused of failing to warn patients about the risks of taking Crestor, the company's "common" cholesterol-lowering medication, and to warn the public about its potential side effects.

AstraZeneca's letter to the FDA stated that it was "not aware of any of these risks or side effects."

AstraZeneca's letter to the FDA stated that the company's letter to the FDA stated that "the company's letter is not the result of any of its known risks."

AstraZeneca is also accused of failing to provide information about the risks and side effects of Crestor in people with a known hypersensitivity to its components.

The company said in a statement that it was "not aware of any of these risks or side effects.

Introduction About CRESTOR 10MG TABLET

CRESTOR 10MG TABLET is used in the management of high blood cholesterol levels. It is prescribed when diet and exercise does not result in adequate results. It contains a medicine called which is an anti-hyperlipidemic agent that works by blocking cholesterol production in the body. It also makes your body eliminate lipids particles from the blood.

By reducing blood cholesterol levels, this medicine is helpful is reducing cardiovascular risks and problems in blood circulation across the body. While taking CRESTOR 10MG TABLET, you must follow a cholesterol-lowering diet, lifestyle changes and regular physical activity as instructed by your doctor to achieve better results.

Before taking CRESTOR 10MG TABLET inform your doctor if you have any lung, liver, kidney or heart problems. You must also inform your doctor if you have diabetes, thyroid problems, or a family history of muscle disorders. Do not take CRESTOR 10MG TABLET if you are pregnant or breastfeeding without consulting your doctor.

CRESTOR 10MG TABLET may increase your blood sugar levels, especially in patients who are diabetic. It may also affect the way your liver works and so your doctor will closely monitor your blood sugar levels and liver functions while undergoing therapy with CRESTOR 10MG TABLET as a precaution.

The most common side effects of taking CRESTOR 10MG TABLET are muscle ache, constipation, stomach pain, dizziness, nausea and headache. Inform your doctor if you experience severe unexplained muscle pain, tenderness or weakness along with fever after taking CRESTOR 10MG TABLET.

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There are no specific directions for taking CRESTOR 10MG TABLET. As with all medications, there is a risk of dizziness or lightheadedness and death has been reported in a small number of patients after taking CRESTOR 10MG TABLET.

In a recent study of patients with diabetes, 6.3% had a pre-diabetic background and 1.7% had a history of stroke.

In patients with a history of atrial fibrillation, taking CRESTOR 10MG TABLET may result in atrial flutter and atrioleptic complex syndrome in patients with diabetes.

While taking CRESTOR 10MG TABLET, YOUCANdo not take nitrates or alpha-blockers if you have an history of myopathy or myasthenia gravis.

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CRESTOR 10MG TABLET is not recommended for use in women, but it is helpful for management of hypercholesterolemia (high cholesterol in your blood) and for patients with heart failure and edema (fluid retention in the blood). It should be used only if you are diagnosed with heart failure and found to be in in very good health.

There are no specific intentions for taking CRESTOR 10MG TABLET.

Crestor sales: What you need to know

The world's leading global pharmaceutical company, AstraZeneca, is introducing a new blockbuster drug to the market that will generate worldwide sales of up to $3.6 billion for the U. S. alone, with a market cap of $2.2 billion.

Crestor, a cholesterol-lowering medicine, is the latest of a string of drugs to hit the market that are likely to see a boost in sales for years to come.

The company announced it will also receive an injection of funds from the U. Food and Drug Administration to help with the company's drug pipeline.

Crestor is the first of a string of medications to enter the market, with a total of 10 new blockbuster drugs coming to market this year.

The U. Food and Drug Administration has approved more than 100 blockbuster drugs since 2001, including AstraZeneca's Crestor and Crestor P20. Crestor is the first of a new class of medications, known as "statins," which work by blocking the body from creating an enzyme called LDL (low-density lipoprotein).

Crestor is the company's second-biggest product launch, having hit the market in 2005.

In addition, Crestor has received approval from the FDA for its use in the treatment of type 2 diabetes. It also was approved for the treatment of high blood pressure.

The company is also in discussions with the U. Food and Drug Administration to develop a generic version of the cholesterol drug, Lipitor, for an early-stage development.

The company will be launching a new drug in mid-October, called Zetia, that is designed to treat high cholesterol levels in patients with heart disease.

Food and Drug Administration is also expected to approve several other products in the pipeline, including a heart drug called Calcium, a calcium channel blocker for hypertension, and a painkiller called Aricept, which may be approved for other uses.

The company expects to launch a number of other products this year and is working with the FDA to get them approved. It is also looking at a number of other potential products, including a new drug for treating certain types of cancer and an antibiotic called Cipro.

The company has a long history of providing health care to patients and their families, and it is now a global leader in the field of medicines.

The company's drug portfolio includes a variety of medicines, including two cholesterol-lowering drugs, AstraZeneca's Crestor and Crestor P20, and several other companies.

The company has a pipeline of products and the U. Food and Drug Administration is looking at new products in the pipeline, including two new drugs for treatment of high cholesterol, and a painkiller, Zoloft.

As the company prepares for its next step in its effort to bring new drugs to market, there is a lot of talk about whether to bring more than two products into the market and start selling them as new drugs.

Crestor, Crestor P20 and Zoloft are the first of the new drugs to enter the market, and will become a huge part of the company's portfolio.

Crestor, the company's second-biggest product, will be introduced by the end of 2009 and is expected to generate $2.5 billion in sales and a market cap of about $1.4 billion.

The company is also working on a new drug in late 2009 to treat an underactive thyroid, which can cause a buildup of thyroid hormone in the body, which can lead to thyroid nodules and enlargement. This will become a big part of Crestor's development.

Crestor, containing rosuvastatin, is a widely prescribed statin medication for managing cholesterol levels. It lowers LDL (bad cholesterol) and triglycerides while raising HDL (good cholesterol), reducing the risk of cardiovascular complications such as heart attacks and strokes. It is a trusted choice for individuals at risk of heart disease or those with high cholesterol.

Benefits of Crestor:

• Effectively lowers bad cholesterol and triglycerides.
• Increases good cholesterol for better heart health.
• Reduces the risk of heart attacks, strokes, and other cardiovascular events.

Dosage:

• Typically taken once daily, with or without food.
• Starting doses and adjustments depend on cholesterol levels and treatment goals.
• Your doctor will determine the appropriate dose for your condition.

Warnings and Precautions:

• Not suitable for pregnant or breastfeeding women.
• Inform your doctor if you have liver disease or a history of muscle disorders.
• Avoid excessive alcohol consumption during treatment.

Usage Instructions:

• Take it at the same time each day for the best results.
• Follow your doctor’s dietary recommendations to optimize effectiveness.
• Do not skip doses or stop treatment without consulting your doctor.

Storage Information:

• Store at room temperature, between 68°F and 77°F (20°C to 25°C).
• Keep away from excessive heat and moisture.
• Store out of reach of children.

Common Side Effects:

• Muscle pain or weakness.
• Mild gastrointestinal discomfort, such as nausea.
• Rarely signs of liver issues or severe muscle problems (seek immediate medical attention).

More information about Crestor:

See also:

• FDA request for Crestor information. FDA deadline Oct. 31, 2004.
• Contact your doctor immediately if you experience signs of liver problems or severe muscle problems. Symptoms may include muscle pain,weakness, or tingling or numbness.

See also information at:

• FDA pregnancy category 0-1b pregnancy category N pregnancy category T. FDA pregnancy category C. FDA pregnancy category R. FDA pregnancy category D. FDA pregnancy category E. FDA pregnancy category F. FDA pregnancy category G. FDA pregnancy category H. FDA pregnancy category I. FDA pregnancy category J. FDA pregnancy category K. FDA pregnancy category L. FDA pregnancy category M. FDA pregnancy category N. FDA pregnancy category P. FDA pregnancy category Q. FDA pregnancy category S. FDA pregnancy category T. Other. [Accessed Oct. 31, 2005]. 31, 2004].