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drug_recall crestorCrestor statin drug was FDA approved in August 2003. Even before it ever reached approval status, Crestor safety was in question. Public Citizen consumer group strongly urged the FDA not to approve the drug, which resulted in a one-year delay because the agency questioned its safety as well. While the Crestor safety was mainly associated with the 80-milligram doses, all of the adverse event reports but one have so far been made for 40-milligram doses or less of Crestor a day.
When Crestor was finally approved, the drug agency had concluded it was safe for use at doses up to 40-milligrams. So far, there have been three U.S. patients that were taking approved Crestor doses that developed kidney failure or muscle damage, including one 39-year old woman that died of kidney failure and rhabdomyolysis. According to data obtained from the U.S., UK, and Canada, it shows seven cases of rhabdomyolysis and nine cases of kidney damage or failure occurred after FDA approval.
What concerns many people about Crestor safety is the drug had only been on the market for a little over five months. While AstraZeneca continues to defend Crestor safety and says its'' safety profile mirrors other approved statins, pre-approval studies showed seven cases of rhabdomyolysis. Even Baycol, a statin drug that was recalled in the fall of 2001, did not show life-threatening instances of rhabdomyolysis in pre-approval clinical studies.
Over two million prescriptions have been written for Crestor. Some people believe when looking at sheer numbers, Crestor safety does not appear to pose a threat. This is not always the case, though, since new drugs that enter the market have routinely been tested on several hundred to several thousand people, which is not enough to find adverse effects occurring in one out of 1,000 or more people. Therefore, some physicians strongly discourage prescribing the latest drug because they believe it is poor care.
Public Citizen petitioned the FDA to remove the drug from the market, especially before AstraZeneca launched its direct to consumers ad campaign, with 60-second television commercials scheduled to appear within weeks. The availability of so many different drug options will often lead to a patient requesting the latest one after becoming familiar with ad campaigns and large marketing efforts. If Crestor safety continues to be a problem, a growing number of consumers may suffer potentially deadly effects.
The consumer group thinks the only way the FDA can react to the Crestor safety problems is to immediately pull it from the market. Director of Public Citizen, Sidney Wolfe believes Crestor safety, because of the potentially deadly effects and lack of evidence showing its efficacy to reduce risks of heart attacks, strokes, and to lower cholesterol, is a unique toxicity that has implications that appear even more dangerous than Baycol.
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...