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drug_recall crestorWhen the British pharmaceutical company Astra-Zeneca launched their prized cholesterol-fighting drug Crestor onto the market, they surely had no idea how controversial it would become. Public Citizen, a U.S. consumer watchdog group, has taken a firm stance opposing the marketing and distribution of Crestor, which they claim causes severe kidney-related side effects and in some cases death.
Even before Crestor was approved by the FDA for use in the United States, Public Citizen opposed the drug based on the risks associated with muscle and kidney damage that could occur with its use. The real fuel for their fire came after FDA approval was given and the drug had entered the market. Within the first year of use, a host of patients taking Crestor for their cholesterol began to exhibit serious side effects that proved dangerous and life-threatening. A 39-year old woman taking Crestor died from kidney damage caused by a rare muscle destroying disease called rhabdomyolysis. Two other U.S. patients along with a number from the U.K. and Canada have exhibited kidney damage or failure along with rhabdomyolysis. Public Citizen has twice petitioned the FDA to ban Crestor from the United States market even after the FDA issued stronger warnings to doctors who prescribe the drug to their patients.
Crestor is a prescription medicine used to treat high blood pressure in combination with a healthy diet and regular exercise. Crestor lowers the so-called "bad cholesterol" or fat-ridden LDL cholesterol that is carried through the bloodstream. It also raises the amount of "good cholesterol" or HDL cholesterol in the body. Crestor is one of the statins, a popular class of cholesterol-lowering drugs that save many lives by reducing the risk of heart disease and stroke. However, all statins have a dangerous side effect to one degree or another. They can injure muscle tissue and potentially cause rhabdomyolysis, a muscle-destroying disease. Muscle dissolved by this disease releases harmful substances to the kidney which can be life-threatening.
Public Citizen believes Crestor to be much more harmful than any other statin on the market, and is particularly likely to cause excessive muscle and kidney damage beyond that of rhabdomyolysis. This was recently expressed by Dr. Sidney Wolfe of Public Citizen, in a letter published in The Lancet, a popular scientific journal, calling for Crestor to be pulled from shelves immediately. Health authorities in Canada have recently issued a new warning to citizens about the risks associated with Crestor. The FDA has also stressed the importance of appropriate dosage levels to physicians in the United States, as well as insisting that patients on Crestor be warned by their doctor of the possible side effects related to muscle injury and kidney failure. But Astra-Zeneca stands by their claim that Crestor is no more dangerous than other statins when given to patients in the appropriate dosage.
Patients taking Crestor or any other statin, the FDA says, should promptly call their doctor if they exhibit 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...