More reasons for Crestor recall presented
The controversial cholesterol-lowering drug Crestor is more likely than other similar drugs (belonging to the family of drugs called statins) to cause muscle deterioration that can lead to kidney disease and failure, according to a study publisher in medical journal, Circulation.
A group of doctors that includes Alawi Alsheikh-Ali, Marietta Ambrose, Jeffrey Kuvin, and Richard Karas, show that their analysis supports concerns about the relative safety of rosuvastatin (sold as Crestor) at the range of doses used in common clinical practice in the general population. It may be recalled that there have been other studies that show the adverse side effects of Crestor and the consumer rights group Public Citizen has demand a recall of Crestor by the FDA - a request that was denied. (Related article: FDA criticizes misleading Crestor ads but refuses a recall)
The new research that challenges the position of FDA shows that Crestor-associated adverse events reported to the FDA raises concerns about the safety of this drug at the range of doses used in common clinical practice in the general population. Accordingly, the scientists recommend that healthcare providers consider other statins as first-line therapy, to initiate therapy in appropriate patients at lower doses, to consider combination LDL-C–lowering therapy(e.g., statin combined with ezetimibe or Zetia), and to vigilantly monitor for adverse events if rosuvastatin is used.
Not all doctors agree with the new research. Dr. Scott Grundy, at the Center for Human Nutrition and Departments of Clinical Nutrition and Internal Medicine, University of Texas Southwestern Medical Center at Dallas, writes in an accompanying editorial that "One must keep in mind that statins generally are safe and that they substantially reduce risk for coronary events in higher-risk patients. Nonetheless, statins, like all drugs, can have side effects, and care must be taken in their use in persons with predisposing conditions."
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A group of doctors that includes Alawi Alsheikh-Ali, Marietta Ambrose, Jeffrey Kuvin, and Richard Karas, show that their analysis supports concerns about the relative safety of rosuvastatin (sold as Crestor) at the range of doses used in common clinical practice in the general population. It may be recalled that there have been other studies that show the adverse side effects of Crestor and the consumer rights group Public Citizen has demand a recall of Crestor by the FDA - a request that was denied. (Related article: FDA criticizes misleading Crestor ads but refuses a recall)
The new research that challenges the position of FDA shows that Crestor-associated adverse events reported to the FDA raises concerns about the safety of this drug at the range of doses used in common clinical practice in the general population. Accordingly, the scientists recommend that healthcare providers consider other statins as first-line therapy, to initiate therapy in appropriate patients at lower doses, to consider combination LDL-C–lowering therapy(e.g., statin combined with ezetimibe or Zetia), and to vigilantly monitor for adverse events if rosuvastatin is used.
Not all doctors agree with the new research. Dr. Scott Grundy, at the Center for Human Nutrition and Departments of Clinical Nutrition and Internal Medicine, University of Texas Southwestern Medical Center at Dallas, writes in an accompanying editorial that "One must keep in mind that statins generally are safe and that they substantially reduce risk for coronary events in higher-risk patients. Nonetheless, statins, like all drugs, can have side effects, and care must be taken in their use in persons with predisposing conditions."
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posted by eCreativa Media | 10:49 AM
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