NEW YORK -- The cholesterol-lowering drug Crestor -- which treats high cholesterol and heart disease -- has been pulled from the market after a clinical trial found that the medication caused heart attacks and strokes in more than half of the patients taking the drug.
The results were announced by AstraZeneca Pharmaceuticals Inc. and Ranbaxy Laboratories Ltd. in a study conducted by the American Heart Association.
The study, called the Crestor-sponsored study, compared patients taking Crestor or a statin pill who had high cholesterol levels for at least the first 3 months of treatment to patients taking a statin pill, said spokeswoman Laura Horshott.
The Crestor study was conducted by the AstraZeneca group of researchers in New York, said David S. Kent, M. D., a professor of medicine at the University of Florida and the head of the company's clinical research program.
The study, a double-blind, placebo-controlled study of 40,000 patients, was conducted at the Cleveland Clinic in Cleveland and was presented Monday at the American Heart Association Scientific Sessions, which is attended by more than 2,000 cardiologists.
The study was sponsored by AstraZeneca, which is a major maker of statins and other drugs that increase the risk of heart attacks and strokes. The company said the results would be published in the New England Journal of Medicine in December 2004.
The study, which included more than 11,000 patients, also showed that patients taking the cholesterol-lowering drug Crestor had an increased risk of developing heart attacks and strokes, and that statin patients were at an increased risk of developing the heart diseases.
Statins work by blocking the action of certain enzymes in the body, called lipids.
The statins are a type of drug that includes the brand name Lipitor and generic versions of Crestor. Both contain the same active ingredient, rosuvastatin, and are prescribed by doctors to treat high cholesterol and triglyceride levels in people with cardiovascular disease.
The Crestor study is the second major study to show that the cholesterol-lowering drug Crestor increases the risk of heart attacks and strokes. It was first announced in 1998 by AstraZeneca.
The results were presented at the American Heart Association Scientific Sessions in New Orleans.
The results are based on a study of more than 1,000 patients, including the Crestor-sponsored study, which has been presented at the annual meeting of the American College of Cardiology.
The trial was a part of the drug maker's attempt to get a drug with a high lipid profile and to make it available for patients to treat their cholesterol.
Crestor was first approved in the United States in 2003 for the treatment of high-risk cholesterol and other conditions, including type 2 diabetes.
The FDA has warned Crestor, a statin commonly used to treat high cholesterol and other conditions, because of the side effects and risks associated with the use of the drug.
Crestor has been approved in more than 100 countries since its launch in the United States in 2009. It has a safety profile, including greater tolerability and less serious side effects than other statins.
Crestor has been on the market since 2003 and the first Crestor product to be approved for the treatment of high cholesterol. It is a newer treatment for patients with heart problems, but was first approved by the FDA in 2003 for the treatment of high-risk cholesterol.
The trial involved patients with cholesterol levels of more than 3,000 milligrams per deciliter. Those levels are measured on a scale from 0 to 4, and those levels are then taken by patients to determine if the drug helps them or not.
The results are expected to be released in the spring of 2004, when AstraZeneca will begin marketing Crestor again.
The trial, conducted by the company's clinical research program, found that patients taking Crestor had an increased risk of developing heart attacks and strokes in patients who took a statin. The risk was also higher in patients taking the cholesterol-lowering drug than in the other statins.
Patients taking the statins also had an increased risk of coronary artery disease, a condition in which the arteries that supply the heart do not close properly. That condition is more common in people who have high blood pressure and heart disease.
The results, which were presented at the American Heart Association Scientific Sessions, showed that the statin patients taking Crestor had an increased risk of developing the heart diseases, including those caused by high cholesterol.
This story was originally reported by The Associated Press.
The cost of a prescription for Crestor, or rosuvastatin calcium, has been raised several times to more than $1 billion by a group of private drug makers.
The price hikes come amid a string of lawsuits by plaintiffs and others who allege that the group was pressured to raise the price of its prescription drug by misleading consumers and other unscrupulous individuals.
In April 2011, a Federal District Court in Brooklyn charged the makers with making false claims against the drugmaker of the drug Crestor, a widely used cholesterol medication.
The case was brought by the plaintiffs in a lawsuit against the group that claimed that Crestor caused an abnormal liver enzyme called ALA, which can damage the liver.
In a ruling, the court ordered the companies to pay the plaintiffs $10 million to settle the case.
In April 2014, the group pleaded guilty to a federal charge of causing false claims in a 2015 settlement with a federal jury in Louisiana for allegedly misleading consumers. They also pleaded guilty to another federal charge of inducing false claims.
The drug companies are currently facing a $2.5 million fine for marketing and promoting the drug to consumers, the FDA, for the first time, said in a statement.
In its latest statement, the companies said they will continue to work with the government to resolve the cases, which are still under investigation by the federal government. The company said it will share its full financial information with the FDA in due course.
The drug companies say they are not making any changes to their marketing and promotion practices. They are seeking to change the way that consumers use their products.
The drug companies say the case was brought after an investigation by the federal Food and Drug Administration that began in 2010 and began with the first hearing on the case in August.
The FDA said its review found Crestor caused the liver enzyme ALA to be elevated in patients taking the drug in doses and dosages of more than 1,000 milligrams.
The group alleged that the FDA illegally marketed Crestor as having little benefit for its patients, and the FDA said it would soon change its marketing practices to include the drug in its labeling.
The FDA said the drug company was aware of the allegations and, after a review, it concluded that the company was not marketing it as a statin drug.
The company said it did not recall the drug’s label or its labeling for Crestor.
The FDA said it was aware of the FDA’s investigation, but declined to comment.
A representative for the company said the drug companies would respond to the consumer complaints if it was appropriate to do so.
“There are no individual complaints from consumers who have been harmed by the drug company’s actions in the past,” said Michael Schumacher, a spokesman for the group, which represents the plaintiffs in the case.
The company is also seeking to change the labeling of the drug to include the drug’s label, which will be updated with information about its uses, side effects and risks.
The group has filed lawsuits against Crestor for alleged fraud, false claims and for false advertising in an effort to market a product that is dangerous, costly and ineffective.
In April 2013, the group filed a petition with the FDA to change the way that consumers use its Crestor drug. The group alleges that the FDA’s efforts to market the drug were illegal, and that the agency acted to mislead consumers.
In June 2014, the group filed a lawsuit against the company in the United States District Court for the District of New Jersey, seeking to change the way that the company uses Crestor to promote Crestor.
In July 2014, the company filed a similar lawsuit against a group of drug makers in the Eastern District of New York, alleging that the company used the drug to increase the cost of Crestor.
In October 2014, the company filed a lawsuit against a group of drug makers in the Middle District of Florida, alleging that the company’s marketing and promotion efforts were illegal.
In January 2015, the group filed a lawsuit against the company in the Eastern District of Virginia, alleging that the company’s marketing and promotion efforts were illegal.
The company has filed a number of other lawsuits against the company, including a lawsuit against the group and the Federal Trade Commission against the company in Connecticut.
In January 2016, the group filed a lawsuit against the company in the District of Columbia, alleging that the company’s marketing and promotion efforts were illegal.
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.
How should I take CRESTOR 10MG TABLET? CRESTOR 10MG TABLET should be used only when high blood cholesterol levels are reduced. Do not increase or decrease the dose of CRESTOR 10MG TABLET in 24 hours without consulting your doctor or pharmacist.Before taking CRESTOR 10MG TABLET inform your doctor if you have heart problems or experience any. You must also inform your doctor if you are taking any medications or are going through a loss-lifers of symptoms.
What are the side effects of CRESTOR 10MG TABLET? Some patients have reported having few or no side effects while taking CRESTOR 10MG TABLET. It may lead to dizziness, headache, or nausea and, if severe, lead to to to experience possible with muscle pain, tenderness along with fever. It may also cause headache or nausea in some patients. There is no common-law-suit-matter for patients who take medications such as antacids, antacids for stomach upset, St. John’s wort, St. John’s wort flower, jn or any herbal products along with CRESTOR 10MG TABLET. Therefore, it is important to note that the side effects of medications like CRESTOR 10MG TABLET are possible but it’s not possible to determine what are the side effects of medications like CRESTOR 10MG TABLET.The detailed information on the side effects of CRESTOR 10MG TABLET is listed and left to right here as a symbol of left field. Patients who experience severe or prolonged side effects while taking this medicine must immediately consult the doctor of a doctor of your choice, if you need any serious side effects and you are taking CRESTOR 10MG TABLET. If you need any of the side effects listed here, please consult your doctor of choice, Dr. OrVERTIS.
The side effects of CRESTOR 10MG TABLET are possible but are not typically serious. They include headache, nausea, vomiting, fits, black hairy tongue, blurred vision, muscle pain, diarrhea, stomach cramps, dizziness, spinning sensation, irregular menstrual periods, and changes in the amount or colour of your urine. It may also cause symptoms such as confusion, hallucinations, fast heartbeat, shortness of breath, shortness of time or wheezing dizzily. They include weakness, pain, shortness of time, dizziness, feeling cold, feeling cold all of which are serious side effects for patients. If you are taking CRESTOR 10MG TABLET and think you may be taking any medication, medical intervention must be taken accordingly.
Although there is no mandatory level of anti-hyperlipid medication medication particles peroxide in the blood, there are some patients who have experienced their blood peroxide level rise as a side effect. These patients must be seenotropically while taking this medicine and must have a blood culture checked while taking this medicine.
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