Submit your Defective Drugs claim details for a free, no obligation case review.
Get Started:
drug_recall crestorCrestor cholesterol drug was FDA approved in August 2003. The cholesterol-lowering statin was delayed approval for a year after the drug agency expressed concern over dangerous adverse events, especially when using the 80-milligram pill. At that time, Public Citizen consumer group strongly urged the FDA not to grant approval to the latest cholesterol drug because of the serious safety concerns. When Crestor cholesterol drug was finally approved, the FDA concluded it was safe when used as directed in up to 40-milligrams.
Public Citizen has now called on the FDA to immediately remove Crestor cholesterol drug from the market following reports of potentially deadly instances of rhabdomyolysis and kidney damage. Rhabdomyolysis is a rare side effect of all statins, including Crestor cholesterol drug, but Public Citizen thinks the toxicity of Crestor makes it more dangerous than other available statins. Baycol cholesterol drug was recalled in the fall of 2001 after it was linked to 31 deaths as a result of rhabdomyolysis.
Just over five months on the market, Crestor cholesterol drug has had seven patients suffer life-threatening instances of rhabdomyolysis and nine patients suffer kidney failure or damage. These reports included a fatal instance of rhabdomyolysis and kidney damage in a 39-year old woman using Crestor cholesterol drug. Even in pre-approval studies, seven patients using Crestor cholesterol drug was struck with cases of rhabdomyolysis, a sign that even Baycol failed to display. It was also noted that in every adverse effect report suffered but one, 11 cited cases by Public Citizen occurred in patients taking 40-milligrams or less of Crestor cholesterol drug a day.
In yet another blow, a consultant to the nation''s largest private health insurer and more than one-third of Fortune 500 companies did not include Crestor on a list of drugs it recommends for reimbursement by insurers and corporations. In addition to Crestor cholesterol drug''s uncertain future as the FDA is currently reviewing its safety implications, the latest decision by Medco Health Solutions, Inc. can jeopardize its future as well. The decision was made after Medco a "clinical and financial review" of Crestor cholesterol drug, according to a Medco spokeswoman. Already, AstraZeneca has felt the impact of the Medco recommendation.
AstraZeneca continues to defend the efficacy and safety of Crestor, telling Wall Street last fall it hoped Crestor would capture up to one-fifth of the $20 billion annual worldwide market for statins. Public Citizen believes the FDA should have never approved Crestor cholesterol drug and thinks the only acceptable way to show concern for patient safety is to withdraw it from the market.
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...