The FDA is expected to release a warning on the use of generic Crestor in the United States, the drug's maker announced Thursday. The agency is also looking into a lawsuit by Pfizer, which has been selling the drug for years, that could include potentially dangerous side effects.
FDA chief executive James Merck said in a statement that the drug was a "significant step" to help patients who may have been taking too much of the medication. In a statement, Merck acknowledged that Crestor could cause adverse events, but that the risk of serious side effects was not known.
"Our analysis of the results of this trial is based on a comprehensive, rigorous, and stringent safety evaluation of Crestor, a widely used and widely prescribed statin," Merck said in a statement. "We believe that a comprehensive safety analysis is warranted to determine the safety profile of Crestor."
Crestor has been on the market for decades. It is a brand-name drug, and was approved in 1997. The original company that marketed Crestor has sold about half of the drug since its patent was filed, but its patents were held by a handful of other manufacturers.
The FDA has twice warned of possible side effects of Crestor in the U. S., but that has been resolved by an appeal. On May 29, 2005, the agency sent a notice to AstraZeneca about the possibility of Crestor being recalled from the market. In a statement, the company said that a recall would "be in the early stages" and "should not occur again."
In a statement, AstraZeneca said the company would make a decision about the safety of Crestor based on the results of the clinical trial.
"This decision will be based on our analysis of the results of the clinical trial, as well as other available data, including the results of other studies," AstraZeneca said in a statement. "Further studies are required to confirm these findings, including the results of the clinical trial, and further studies are required to assess the long-term safety of this drug."
The FDA has issued two safety warnings, in June 2004 and in July 2005, to Crestor's maker, Merck, which had sued the company in April 2001 for failing to warn of potential adverse events. Merck filed a motion seeking to prevent the company from recalling the drug, arguing that the safety of the drug was unknown at the time. In March, the agency ordered AstraZeneca to immediately stop selling the drug to consumers and stop marketing the drug.
The FDA is expected to release a warning to consumers on June 3, 2006, and a statement will follow the announcement on May 29, 2005, and the FDA's final warning.
Crestor is used to treat a variety of conditions, including high blood pressure, high cholesterol, diabetes, and some cancers. In 2003, Crestor was approved for use as a heart medication, and in 2005, it was approved as a heart medication.
Last month, a federal court in California dismissed AstraZeneca's claim that the company improperly hid the risk of heart attacks and strokes from its marketing of Crestor in the U. S. and Canada.
AstraZeneca said the warning about the potential side effects of Crestor was based on a study and not a "complete lack of data," which is not at issue in the case.
It also said that Crestor, when marketed in the U. as a heart drug, should not be sold to consumers without the proper precautions. In the case of Crestor, the company had already warned consumers of potential side effects. The FDA also said that the warning about the potential risk of a heart attack or stroke should be communicated to consumers in the form of a written warning letter.
In its press release, AstraZeneca said that the company is "reviewing its clinical trials and conducting further studies to ensure that the safety profile of Crestor is not altered by this safety warning."
According to the release, the company is reviewing the results of the study to determine if there is a safety risk to Crestor, and will include the results of other clinical trials. In particular, the company is reviewing "all the available data that has been collected to support the safety profile of Crestor."
Crestor has been linked to an increased risk of death in patients who take the drug. In a 2005 case in California, the company had been trying to get a recall of Crestor from the drug maker, Pfizer, and the warning of an increased risk of death was not included in the FDA's summary of product safety information.
Crestor 10mg is a cholesterol-lowering medication for individuals with heterozygous familial hypercholesterolemia. It works by blocking the production of cholesterol in the liver, helping to reduce high-density lipoprotein (HDL) levels and improve lipid profiles. This medication is available as a tablet and extended release tablet. It is used to treat high-density lipoprotein (HDL) levels in people with homozygous familial hypercholesterolemia (HFL).
Crestor 10mg contains a non-steroidal anti-inflammatory drug (NSAID), rochilexin. It is used for the reduction of high cholesterol levels, and it has been shown to be an effective medication for reducing the risk of coronary heart disease. Crestor 10mg is used to lower the LDL level by 50 percent. It helps increase the levels of HDL, reducing the risk of atherosclerosis (hardening of the arteries). The drug is available as a capsule and extended release tablet. It may be taken with or without food.
The dosage is based on individual response to the drug and is intended to be taken once daily at the same time each day. The maximum daily dose is 20 mg.
The active ingredient, rochilexin, is in a class of medications known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by inhibiting the production of certain chemicals in the body that cause inflammation and pain. The active ingredient also is used to prevent cardiovascular disease.
Crestor 10mg is a cholesterol-lowering medication for individuals with heterozygous familial hypercholesterolemia (HFL).
Rosuvastatin, commonly known as Crestor, is a widely used medication for managing high cholesterol and lowering the risk of heart disease. Here atWalgreenswe offer a range ofCrestor Oral Capsulesdesigned to suit individual needs and preferences.
Disclaimer:The information contained in this website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your doctor accurate in the following matters: If you have unexplained muscle pain or weakness, please contact your doctor immediately
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A new cholesterol-lowering drug from Canada was shown to lower the risk of heart attacks and stroke in a small group of patients with a rare inherited eye disease, the new study shows.
The study, published in the New England Journal of Medicine, compared the results of simvastatin, a cholesterol-lowering drug from Canada, to a group of people who had previously been treated with an older drug called Zocor (rosuvastatin), and a group who had not.
The researchers, who led the study, recruited 12,049 adults with a known familial risk of inherited eye disease and had a known risk of heart attacks and stroke. The patients were also asked about their risk of having a new blood test for elevated LDL (bad) cholesterol and their risk of having a new blood test for high-density lipoprotein (HDL) cholesterol and a family history of heart disease.
The patients were randomly assigned to take a drug known as rosuvastatin (marketed as Crestor®) or a dummy drug, the researchers found. The rosuvastatin group was more likely to develop heart attacks and stroke when compared to the dummy group.
The researchers found that patients taking rosuvastatin were less likely to have a new blood test for elevated LDL cholesterol and had a greater risk of heart attacks and stroke than those who took dummy drug. Rosuvastatin was also less likely to have a family history of heart disease than the dummy drug.
"Our study shows that statin use in patients with a rare inherited eye disease is associated with a lower risk of developing a new blood test for elevated LDL cholesterol and an increased risk of developing a new blood test for high-density lipoprotein (HDL) cholesterol and a family history of heart disease," the authors write.
The findings suggest that statin use may be associated with a reduction in the risk of heart attacks and stroke in patients with a rare inherited eye disease.
The study was presented at the American Heart Association Scientific Sessions, the annual meeting in New Orleans, LA, on Oct. 28-29, 2013, at the American College of Cardiology Scientific Sessions Center for Prevention of Cardiovascular Disease.
In the heart of the study, the researchers found that patients taking rosuvastatin were less likely to have a new blood test for elevated LDL cholesterol and had a greater risk of developing a new blood test for high-density lipoprotein (HDL) cholesterol and a family history of heart disease.
The findings were not statistically significant.
The study is published in the New England Journal of Medicine.
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LOSS OF OVERVIEW
Here are some facts about the study:• The study was conducted in two separate geographical areas with different populations and ethnic groups.
• The patients were randomly assigned to take rosuvastatin or a dummy drug.
• The rosuvastatin group was more likely to have a family history of heart disease.
• Rosuvastatin was less likely to have a family history of heart disease than the dummy drug.
• The findings were statistically significant.
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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