WASHINGTON — In a move that would have saved millions in the United States in the year to end-March 2019, the Food and Drug Administration has issued a warning on its website about a study of some statins that had already been approved for use by patients with heart disease. The new warning was prompted in part by a study in late March, which found that the highest doses of Crestor, which is used to treat patients with elevated cholesterol levels, were associated with a slightly higher risk of heart attacks and strokes.
The drug, known generically as rosuvastatin, was initially approved for use by AstraZeneca, the maker of Crestor.
But by August, the FDA has revised its warning to include the statins.
The new warning, published in the August issue of the Journal of the American Medical Association, includes a study of 10,000 patients who had taken the drug for a total of 12 months. The study was conducted by researchers from the University of Pittsburgh and Harvard Medical School. The drug was taken by more than 5,400 patients from the United States, and the study's authors wrote in their journal on August 29.
The researchers concluded, "These findings raise concerns about a possible increased risk of heart attacks and strokes among patients taking Crestor."
The warning also was updated in April. The agency has not issued any specific updates on the drug's side effects.
The warning also was updated in May and June.
The new warnings are based on an earlier study that showed that a small number of patients with high cholesterol in their lifetime were more likely to be taking Crestor than those who had not.
The study was performed by researchers from the University of Pittsburgh, and it was published in the journal "Clinical Heart Research" on May 6.
The FDA, which had previously approved the use of Crestor in people with high cholesterol to treat people with a primary cardiovascular condition, was now revising the warning.
A spokeswoman for AstraZeneca, which makes the drug, said that the study had been conducted "under a close monitoring program."
"This study is a follow-up of a study which was performed in 2004," she said in an interview with. "We're doing this on a case-by-case basis."
AstraZeneca is still reviewing the data, she said, and it remains uncertain if the data will change in the future.
The FDA is still reviewing the new warning, and a spokeswoman for AstraZeneca said it was reviewing the study "as part of our ongoing investigation" and would return it to the FDA for further analysis.
The FDA also has not issued specific updates on the drug's side effects.
In May, the agency issued a warning that included a study in the "Clinical Trials of Rosuvastatin" that had been conducted by three large randomized, double-blind, placebo-controlled clinical trials. The study, called CRESTOR®, included patients with elevated cholesterol levels who had not taken Crestor for at least 12 months. The drugs had been taken by more than 6,000 patients over a 12-month period.
The FDA also warned that a small number of patients had been taking statins for heart attacks or strokes.
"We believe that the risk of cardiovascular events associated with statins is greatest when combined with the use of other statins," the agency wrote in its warning, which was published on August 29.
In its warning, the agency warned that the increased risk was not explained by the use of other statins, and that the drug was taken for a shorter period of time than had been used by patients who had been on statins for more than 12 months.
The drug's label is unclear whether it was approved for use in patients with elevated cholesterol, but it is expected to be in the FDA's final review of the issue.
The FDA is also reviewing the new warning, and it will be reviewing the study.
Originally Published: July 29, 2013 at 12:00 AM EDT
WASHINGTON -- AstraZeneca today announced that the company has reached a preliminary agreement to settle a class-action suit by more than 4,300 patients who took the drug to treat heart disease.The FDA said that the company "may continue to monitor the results of this study, and we will conduct further investigation and evaluate the safety and efficacy of the trial and the results of this study," according to the company.
• 4-5 weeks, stop treatment and inform your doctor if your symptoms persist or worsen
• 6-12 weeks, consult your doctor if your symptoms worsen or do not improve,
Your doctor may increase your dose
3. • Continue treatment for 5-10 days
For example, your doctor may increase your dose of Rosuvastatin from 5-10 mg to 6-12.5 mg/day
If your symptoms persist or worsen, notify your doctor if your treatment plan remains ineffective. Continue treatment for 5-10 days and inform your doctor if your symptoms persist or worsen. Your doctor will likely start you on a lower dose of 5-10 mg of Rosuvastatin. Continue treatment for 5-10 days and consider resuming your treatment if you experience a worsening or no improvement in your symptoms. If you experience any severe side effects, discontinue rosuvastatin and notify your doctor promptly.
• 4-5 weeks, decrease your dose to 2.5-5.0 mg/day
If your symptoms persist or worsen, notify your doctor immediately
4. • Continue treatment for 10-20 days
For example, your doctor may increase your dose of Crestor to 20 mg every 4-6 hours, or increase your dose to 20 mg every 4-8 hours. Continue treatment for 20-30 minutes and inform your doctor if your treatment plan remains ineffective. Continue treatment for 10-20 minutes and the dose may decrease to 20 mg of Crestor. Continue treatment for 4-5 weeks, and continue your treatment for 4-6 weeks. If symptoms worsen or persist for more than 6 weeks, notify your doctor.
• 4-5 weeks, decrease your dose to 5-10 mg of Crestor
• Continue treatment for 4-5 weeks
For example, your doctor may decrease your dose to 5-10 mg of Crestor.
• 4-5 weeks, decrease your dose to 10-20 mg of Crestor
For example, your doctor may decrease your dose to 4-5 weeks.
For example, your doctor may decrease your dose of Crestor to 4-5 weeks.
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:
Dosage:
Warnings and Precautions:
Usage Instructions:
Storage Information:
Common Side Effects:
More information about Crestor:
References[1] Rosuvastatin Calcium 12.5mg/5ml (Rosuvastatin). In: Statins. How to Use. Available from: (10/2012) Web: (Is not available yet Is not available in Canada) [Last updated on:01/2016 @ 12:30]
AstraZeneca [ distribution] [ accessed:] Available at:
AstraZeneca [ accession No. []accessed:
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