The Food and Drug Administration is warning consumers not to buy Crestor, one of the leading statins, because of possible health risks.
The FDA issued a warning letter Wednesday warning consumers not to buy Crestor, one of the leading statins, because of possible health risks.
In a letter posted online by the company, the FDA said: "In some cases where a patient is prescribed a particular medication or if a statin is used, the likelihood that the patient would take a statin at the same time with the same active ingredient or at the same dosage increases and the patient would suffer from an increased risk of an increased heart attack."
In a statement issued late Tuesday, the FDA said it has determined no safety issues with the drug.
"The risk of cardiovascular disease, particularly heart attack, increases with increasing dosages and increases in the number of patients taking the drug," the statement said.
Crestor was developed as a cholesterol-lowering medication for the treatment of type 2 diabetes and high blood pressure. It was first approved by the U. S. Food and Drug Administration in March 2003, and has been on the market since then.
According to the FDA, "In some cases where a patient is prescribed a particular medication or if a statin is used," the increased heart attack risk increases. "With the increased heart attack risk and increased heart failure risk, patients should be closely monitored for signs of worsening symptoms or changes in the patient's medical condition."
The company also said Crestor could pose serious health risks to patients taking the drug.
The FDA's warning letter also noted that Crestor contains both a statin and a drug ingredient that may interact with the active ingredient in the drug.
A study published in the July issue of the Journal of the American Medical Association found that the drug is associated with increased risk of heart attacks and strokes, particularly among the elderly, as well as among patients on certain medications.
The FDA said there are multiple ways to treat high cholesterol, including statins.
It's not clear whether the statin is the same as the drug ingredient found in other statins, but the FDA said there is "no evidence that the active ingredient in Crestor can interact with the drug."
The drug manufacturer says it has not seen any significant changes in its product labeling for Crestor.
The FDA said in a statement that "this is not a new safety concern and the safety of this drug cannot be considered new safety issues."
In a related warning letter posted Monday, it said: "In some cases where a patient is prescribed a particular medication or if a statin is used, the likelihood that the patient would take a statin at the same time with the same active ingredient or at the same dosage increases and the patient would suffer from an increased risk of an increased heart attack."
The company also said it has determined no safety issues with Crestor.The company says it has not received any reports of adverse events related to Crestor.
In the letter, the FDA said the company said it has determined that it has determined no safety issues with Crestor.The company said it has determined that it has determined that there was no risk of serious harm to patients taking Crestor.A spokesperson for Pfizer, the company that manufactures Crestor, declined to comment.
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Media Enquiries: Daniel P. Kuczyny, Ph. D., (202) 512-5842 Fax: (202) 512-5842 Mesteri Gaj, Ph. D., Ph. D.,oultry and poultry analyst[email protected]Citations: No, this material is not a complete and free service. All material is provided for informational purposes and educational purposes, but no guarantee is made that it is accurate or reliable. Repository sites are attemptlessly and intentionally designed to be a dumping ground for information. Repository sites are not intended for professional or educational use and may not be used as a substitute for professional medical advice, diagnosis, or treatment.D., (202) 512-5842 Mesteri Gaj, Ph. D.Richer is taking Crestor (rosuvastatin calcium) the other day.
What is Crestor?Crestor is a medication that is used to lower cholesterol levels. It lowers bad cholesterol, or triglycerides, in the blood. It also reduces good cholesterol, which is also cholesterol.
Rosuvastatin is a statin medication. It lowers high cholesterol and lowers LDL (bad cholesterol) and triglycerides in the blood. It also reduces the bad cholesterol, or triglycerides, in the blood.
Crestor is also used to prevent heart attacks, strokes, heart attacks, and kidney problems in adults and children aged 1 year and up.
Crestor may cause side effects, including muscle weakness, muscle pain, and tiredness. Talk to your doctor if these symptoms persist or worsen.
Ingredients:Crestor is a calcium-3,6-diamino-5,11-dimethyl-p-hydroxy-6-(-piperazinyl) pyrido[4,3-a]indocus, as an active ingredient. It works by helping to block the production of cholesterol by the body. Crestor is available as an oral tablet and oral solution. It comes in a 120 mg/5 mL, or a 60 mg/5 mL, dosage strength.
Warnings:Consult your doctor or pharmacist before using Crestor, or if you have any concerns about any of the products on this website.
Talk to your doctor before taking Crestor if you:
Dosage:Crestor is most effective when taken as a daily pill. It is taken once a day, either with or without meals. You take it by mouth once a day at the same time each day. You may take it with or without meals in a lower dose of 120 mg/5 mL if needed.
Do not exceed the recommended dose.Dosage changes may occur with Crestor. Discuss with your doctor if you would prefer not to take it.
Consult your doctor or pharmacist before taking this medication if:
Possible side effects:Side effects may include chest pain, irregular heart beat, muscle pain, and weakness. If any of the symptoms gets worse or does not go away, or if you experience unusual bleeding or bruising, stop taking Crestor and inform your doctor. Your doctor will discuss with you what to do next if you experience any of the side effects.
Call your doctor for medical advice about side effects, if you have any questions. You may report side effects to FDA at 1-800-FDA-1088.
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 taken seriously if you suffer from high cholesterol levels in your blood. It increments based on dosage works best for mild to moderate hyperlipidemia. It should not be used in patients with hyperlipidemia ( fatty liver – this can lead tois patients to avoid cutting down on fat).The recommended dosage of CRESTOR 10MG TABLET is one tablet taken with water and one with a meal. The recommended dosage is one tablet of CRESTOR 10MG TABLET, taken as needed up to a maximum of one dose per day. The maximum recommended dosing frequency is once per day.
The most common side effects of taking CRESTOR 10MG TABLET are muscle pain, tenderness or weakness, and headache. They can be managed by taking CRESTOR 10MG TABLET along with follows likeokingly or dailyMINAFORMIN therapy:
It is important to inform your doctor about any side effects you have along with patience when taking 10mg per day of CRESTOR 10MG TABLET like the following.
Highlights:
Your doctor will probably tell you to stop taking Crestor, but it’s important to follow your doctor’s instructions. Crestor is generally safe for most people to use.
Like all medicines, Crestor can cause side effects. Common side effects include:
If you experience more severe side effects, such as difficulty breathing, or a fever, talk to your doctor.
If your side effects are not getting better or if you have other side effects, your doctor may decrease your dose or recommend a different treatment.
Before using Crestor, tell your doctor if you:
Your doctor may increase your dose of Crestor to see if you can prevent more serious side effects.
Crestor can make you drowsy and less able to relax. Do not drive or do anything else that could be dangerous until you know how you react to this medicine.
Although Crestor can cause side effects, they’re not limited to the stomach pain and ulcers caused by high blood pressure.
Like all medicines, Crestor can interact with other medicines. Tell your doctor about any:
Some people may experience blood clots that are different to those that were previously uncommonly seen.
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