AstraZeneca’s decision to stop the use of its Crestor (rosuvastatin) medication in high cholesterol levels raises the risk of heart disease, a report from theBMJnotes. The drug, which is the generic form of Crestor, has already been withdrawn in several countries because of safety concerns.
The UK-basedconcluded that “the impact of this decision should be weighed against the benefits to patients and the potential for increased healthcare costs.”
The British pharmaceutical company said the drug’s safety profile “does not justify the withdrawal of Crestor” and said the decision to stop the drug would be made after “important scientific, clinical, and ethical considerations.”
Thereported that it is reviewing the results of the’s study, which was conducted on patients with low cholesterol, and found that Crestor is not the preferred treatment for the majority of those with cholesterol problems.
The study’s findings were published in the’s journalBMJ-OLJ Open. The study’s authors were Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. The researchers said they did not feel the study’s findings would cause alarm or make the decision to withdraw Crestor in the next few years.
The British journal has not yet issued its own statement.
AstraZeneca has said it has received no negative side-effects from Crestor. However, the drug’s label says it can cause a rare but serious allergic reaction known as a cutaneous reaction.
report noted that Crestor and other statins have been withdrawn in several countries because of side-effects. The company said the results of the study “may suggest that the safety profile of Crestor may not be as robust as that suggested by the British study.”
AstraZeneca said it believes it has a “significant safety benefit” of preventing and treating high cholesterol and lowering the risk of heart disease.
“Crestor is a very effective and well-tolerated drug that has been associated with very modest increases in cardiovascular events in patients taking at least 40 mg of the drug daily and no adverse events were reported. The company has a well-established safety profile and is continuing to monitor and discuss any potential adverse events in patients being treated with Crestor,” AstraZeneca said.
The report is due later in the month.
The report also found that Crestor has a “significantly increased risk of developing serious cardiovascular events, including myocardial infarction and stroke.”
The company said that Crestor “has demonstrated efficacy and safety in randomized controlled trials involving more than 300,000 patients.”
The report said Crestor has been withdrawn from the market because of safety concerns.
It said Crestor had been withdrawn for several years because of cost concerns and safety issues.
The report also noted that Crestor has been withdrawn for several years because of cost-related concerns.
AstraZeneca said it is “committed to continue to follow the clinical trials and clinical data that we have performed to evaluate the safety and efficacy of Crestor in our patients.”
In a statement, AstraZeneca said: “We have conducted multiple, long-term studies to evaluate the long-term safety of Crestor in the treatment of patients with hyperlipidemia.”
The company added: “Our clinical trials are ongoing to evaluate the safety and efficacy of Crestor in patients with diabetes mellitus.”
Crestor is an inhibitor of cyclo-oxygenase (COX) enzymes, which are involved in the metabolism of cholesterol. It blocks the action of these enzymes.Crestor has been associated with a higher risk of myocardial infarction and stroke compared with other statins, including atorvastatin.
study was conducted on patients with high cholesterol who were enrolled in a randomized trial. The trial included patients with low levels of total cholesterol and high levels of LDL.
Rx 1:crestor 20 mgDosage
Crestor 20 mg is an extended-release tablet containing rosuvastatin calcium. It is used to lower cholesterol and triglycerides in adults and adolescents (5-18 years of age) with a family history of cholesterol or triglyceride-lowering agents hypercholesterolemia. It is used to reduce cardiovascular events (heart attacks, strokes, and cardiovascular hospitalizations) and to prevent strokes and myocardial infarction (heart attack) from myopathy, in adults and adults with familial hypercholesterolemia. In adults and adults with LDL apheresis, it is used to reduce total- LDL and LDL apolarroteinirhea, and in adults and adults with familial hypercholesterolemia, it is used to reduce the risk of cardiovascular events, including cardiovascular atherosclerosis, in patients with LDL apolarosis. It is also used to prevent stroke or myocardial infarction (temporary, worsening coronary atherosclerosis).
Rx 2:crestor 5 mg
This medicine is a once-daily tablet. Once daily tablets should be taken twice daily at the same time each day. The dose should not be changed more than every 3 months. To reduce the risk of thrombotic thromboembolic disorders, reduce your dose of rosuvastatin by starting at 3 months of age and continuing for 5 years or older, unless your doctor advises you to stop. Continue to take this medicine even if you feel well. Do not take 2 medicine at the same time if you are taking rosuvastatin 2 mg once daily. If you are taking rosuvastatin and experience bleeding or bruising while taking this medicine, stop taking and avoid sexual activity. Do not drink alcohol while taking this medicine.
The following information is only to help you understand the correct dosage of this medicine: To reduce the risk of stroke, myalgia, and other types of pain in the legs, ankles, or feet. For other uses, ask your pharmacist.
Rx 3:crestor 10 mg
In adults and children with familial hypercholesterolemia (i.e., who have a family history of coronary artery disease) the usual dose is 10 mg once daily, taken once daily in the morning. However, in some patients, the dose may be increased to 20 mg once daily in the evening. You may need to take this medicine for as long as you need to feel symptom relief. The maximum recommended dose is 20 mg daily. If you have hypertension, this medicine is not recommended. Ask your doctor or pharmacist for more information.
Rx 4:
This medicine is available as the brand-name Crestor (rosuvastatin calcium). If you are taking a generic rosuvastatin, your prescription will be different. The recommended starting dose is 10 mg once daily in the morning. If you are taking a brand-name rosuvastatin, the starting dose may be 20 mg daily. If you are taking a generic rosuvastatin, your dosage may be changed to 20 mg once daily in the evening. Lower doses (e.g., 10 mg once daily) of rosuvastatin may be taken for longer periods of time. If the usual recommended daily dose is 20 mg daily, your doctor may increase your dose to 20 mg daily.
Rx 5:
A once-daily tablet of rosuvastatin is available in the form of a 10 mg tablet. If your doctor tells you to take a brand-name rosuvastatin, you will need to start at 10 mg once daily. In some patients, the usual dose is 20 mg once daily in the morning. If the usual recommended dose is 20 mg daily, your doctor may increase your dose to 20 mg daily.
If you take a generic rosuvastatin and are not taking a brand-name rosuvastatin, your doctor may increase your dose to 20 mg daily.
Riclox Pharmaceuticals is a joint venture between Schering-Plough Corp. (the 'Company') and Boehringer Ingelheim Laboratories, Inc. (the 'Company' or the 'Company') to develop and commercialize a generic version of AstraZeneca's prescription anti-cancer drug, Crestor.
Under the terms of a US-imposed exclusivity deal with the Company, Riclox will be required to pay $65 million to the pharmaceutical companies in exchange for the exclusive rights to market the generic version of Crestor in the United States. The exclusivity deal will allow the US government to make a drug that would be cheaper than Crestor, which would be available only through a marketing authorization from the US Food and Drug Administration (USFDA).
The exclusivity deal is contingent upon the Company's approval by the US FDA of a generic version of AstraZeneca's Lipitor, Crestor, in a Phase III study.
Under the terms of the agreement, which is subject to an agreement between the Company and the USFDA, the exclusivity period for the Company's product would run from January 1, 2015 to December 31, 2015. The exclusivity period will begin to run on January 30, 2016. The exclusive period has not been set forth in any other terms of the agreement.
According to a press release from the USFDA, the USFDA has notified that it is seeking approval of the Company's Lipitor as a drug to treat patients with high levels of LDL (low-density lipoprotein) and triglycerides, and to improve the cholesterol levels in patients with type 2 diabetes. The company is also seeking approval to develop an alternative drug for patients with type 1 diabetes and patients with dyslipidemia.
According to the press release, the Company has reached an agreement with the USFDA that requires the company to provide a copy of the results of the Lipitor Phase III clinical trial to the USFDA. The company will also notify the USFDA that it is taking an early step in this process and is committed to resolving the dispute.
In addition to the terms of the agreement with the USFDA, the terms of the company's product exclusivity deal with Schering-Plough and Boehringer Ingelheim will also provide details about the company's expectations and future intentions for its product.
Crestor was introduced in the U. S. in November 2001. Crestor was approved in the U. on July 29, 2002 and is indicated for use in patients with high levels of LDL (low-density lipoprotein) cholesterol and triglycerides.
Read moreOn July 22, 2002, the Company filed its first patent application for Crestor, which was granted to the USFDA on August 10, 2002. The patent application is titled 'AstraZeneca Pharmaceuticals LP v. AstraZeneca'. The application has the legal effect of adding a 'Patent Term' to an 'Actual Patent'.
On July 29, 2002, the USFDA granted approval for a USPTO (Patent for Pharmaceuticals and Special Marketing Authorization) for Crestor, the generic version of AstraZeneca's Lipitor.
On October 15, 2002, the USFDA approved an application to add a 'Patent Term' to AstraZeneca's marketing authorization program for Crestor in the U. S., for a "Patent to Drug Application" for Crestor and a 'Patent to Drug Application' for AstraZeneca's Lipitor.
On October 16, 2002, the USFDA approved an application to add a 'Patent Term' to the marketing authorization program of AstraZeneca's Lipitor.
On December 15, 2002, the USFDA approved an application to add a 'Patent to Drug Application' for Crestor, a drug to lower triglycerides and the other therapeutic groups, and a 'Patent to Drug Application' for AstraZeneca's Lipitor.
On January 1, 2003, the USFDA approved an application to add a 'Patent to Drug Application' to AstraZeneca's marketing authorization program for Crestor and a 'Patent to Drug Application' for AstraZeneca's Lipitor.
Crestor works by reducing a user’s levels of cholesterol in the body.
Crestor is a branded anti-cholesterol medication primarily used to lower
cholesterol in patients with a history of coronary artery disease, high
hepatocytic rate of arteries, orchitis, and high-density lipoproteins B and C. It is also sold
to treat high-density lipoprotein (also known as HHD), or
cholesterol-related heart disease.
It’s important to note that Crestor only works when you are prescribed
Crestor.
It should never be taken in either alone or in amealiseby the patient.
Crestor comes in two forms:
are available in two strengths, and 20mg is accessible through your medication.
Crestor 10mg tablets are prescribed for treating
cholesterol-related cholesterol, while 20mg is accessible through your medication.
Crestor 20mg tablets are available only in patients who are overweight.
by a patient.
It’s important to note that when used along with a reduced-calorie
diet
medication, the patient can achieve
by reducing their
cholesterol.
Crestor can help to lower
cholesterol levels, while 20mg is accessible through your medication.
If you are not diet-friendly, your doctor may suggest reducing your
cholesterol when starting treatment with Crestor.
Your doctor may also suggest reducing your
medication in patients with a history of
or
having a
systemic lupus
type 1
.-a condition in which your immune system attacks your lipid profiles in the body, causing you to be
lately lesecken
een
to have irregular heartbeat and palpitations.
If you’re overweight, talk to your doctor about whether
Crestor works for you.
If you’re not physically active, or have
or other lipid-lowering
related conditions, your doctor can help you find a
therapeutic approach to managing symptoms of high cholesterol.
If you’re in the US or Europe, the first
to take Crestor
is to contact your local health care professional,
or.
Crestor can come in both brand-name and generic forms, and it specialises in treating cholesterol levels.
Crestor is available in three strengths:
of which 8 tablets are suitable for children.
are a well-known adverse effect. However, it is notaundicosis and
are not recommended for patients with.
Crestor
can cause dizziness and drowsiness.
Drowsiness and fatigue are serious side effects. If you
are over 65 years old, or if you feel dizzy or tired, then contact your doctor.
Do not take Crestor if you
are
over 65 years old.
Patients with underactive thyroid can develop thyroid cancer and should consult their doctor before taking the medication.
Stade de France Pharmacy