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drug_recall crestorSince its approval by the FDA in August of 2003, a number of concerns have come to the attention of regulators, manufacturers, and users of Crestor, the highly touted cholesterol-lowering drug. Although the drug was initially surrounded by warnings of severe and life threatening side effects, nobody could have predicted the speed with which those concerns would be justified.
Within a year of Crestor being distributed for use in the United States, a 39-year old woman taking the medication died from kidney problems caused by a rare muscle destroying disease called rhabdomyolysis, Along with a handful of reported cases of kidney failure among patients taking Crestor across the U.S., U.K., and Canada within the same year, a reason for concern was present. This prompted Public Citizen, a U.S. consumer watchdog group, to petition the FDA for the immediate ban of Crestor, citing the dangerous and potentially fatal side effects associated with the drug. This was not the first time Public Citizen had made their objections public surrounding Crestor and its distribution. Before the drug even gained FDA approval, Public Citizen questioned the effectiveness and safety of Crestor in numerous clinical trials, effectively postponing FDA approval for nearly a year. But in the end Crestor was sent into the market with the backing of regulators, even amid concerns about the potential side effects.
Crestor, a member of a class of drugs commonly referred to as statins, is used to fight abnormally high cholesterol levels. Working in conjunction with a healthy diet and an active physical exercise routine, Crestor lowers the overall cholesterol count in the blood. It reduces the amount of fatty LDL''s, or so-called "bad cholesterol," while increasing the amount of HDL''s, or "good cholesterol." The drug has proven effective in its focus of reducing the risk of cholesterol related health problems such as heart disease and stroke, but all statins are linked, to some degree, to a dangerous potential side effect: rhabdomyolysis. This disease injures the body''s muscle tissue, dissolving it and releasing toxic substances to the kidney in the process, which in some cases leads to death. Baycol, another cholesterol-lowering statin, was recalled in 2001 and subsequently linked to over 100 cases of rhabdomyolysis in its users. Crestor is beginning to draw comparisons to Baycol, with many patients reporting symptoms of the disease.
Although the FDA has refused to take Crestor off the shelves in the U.S., it recently issued a new advisory to physicians around the country who prescribe the drug, reminding them of the importance of appropriate dosage levels. The FDA advisory follows a new warning label released in Europe by Crestor manufacturer Astra-Zeneca Pharmaceuticals, which proposes that all patients be given a four-week trial dosage at the lowest level, 10 milligrams, rather than a higher dose. Health Canada has become the latest country to warn its residents of the hazards associated with Crestor, recently issuing a new warning linking the drug with rhabdomyolysis, while the esteemed scientific journal The Lancet has published an open letter from Dr. Sidney Wolfe that calls for Crestor to be pulled from shelves immediately.
Patients taking Crestor or any other statin, the FDA says, should call their doctor immediately if they exhibit symptoms such as muscle pain or weakness, fever, dark urine, nausea or vomiting.
The consumer advocacy group Public Citizen submitted a petition to the FDA a year ago asking the agency to immediately withdraw the anti-cholesterol drug Crestor, but the agency has denied its request.
Crestor belongs to a group of drugs ...
The FDA has announced that Crestor is being relabeled to add a warning that starter doses should be reduced in Asian-American patients, as well as some other higher risk patients.
A clinical trial found that levels in Asian patients were d...
The FDA announced a revised drug labeling for the cholesterol-lowering drug Crestor would be added, warning of the serious muscle damage called rhabdomyolysis.
A clinical trial found levels of Crestor in Asian patients were double those of C...