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drug_recall crestorIf Dr. Sidney Wolfe, health research group director of the watchdog group Public Citizen, had his way, the FDA would have Crestor banned from pharmaceutical shelves nationwide. Although the jury is still out on issuing a Crestor ban, Wolfe and Public Citizen continue to do everything they can to get the cholesterol-fighting drug off the market; this includes having a letter published in the scientific journal The Lancet, publicly requesting that Crestor be pulled from shelves immediately. Public Citizen recently petitioned the FDA, calling for an immediate Crestor ban, citing the death of one woman and the damaging side effects within the first year found in a handful of patients across the U.S., U.K., and Canada who were taking the drug at normal doses. The death of the 39-year old woman came as a result of extensive kidney damage caused by a rare muscle-destroying disease called rhabdomyolysis.
Although they have not officially banned Crestor from distribution, the FDA has recently issued a new warning about the drug, advising doctors to be careful about whom they prescribe Crestor to, and the dosage they recommend. In Europe, regulators have also strengthened the labeling requirements on Crestor, stressing that patients in all 22 European Union countries should be given a four-week trial dosage at the lowest possible level, 10 milligrams, while Health Canada has recently issued a new warning to its residents regarding the high risk of side effects.
Crestor is a drug intended to treat those with abnormally high cholesterol by lowering the total amount of cholesterol in the blood. Crestor works by eliminating the fat-ridden LDL'', or "bad cholesterol," while increasing the amount of HDL''s, or "good cholesterol," in the bloodstream. Along with a regular exercise regimen and healthy diet, Crestor has proven effective in its main focus, but the drug does not come without the risk of serious and potentially deadly side effects.
Crestor is considered a statin, which is a popular category of cholesterol-lowering drugs. All statins are intended to lower the risk of heart disease and stroke, but all statins come with a dangerous potential side effect. They can injure the body''s muscle tissue and in some cases cause the muscle-destroying disease rhabdomyolysis. As the muscle is dissolved during rhabdomyolysis, it emits substances that are harmful and potentially fatal to the kidney.
Before the drug even hit the market, Public Citizen advocated having Crestor banned from production and distribution. The group urged the FDA not to grant approval to Crestor and had it delayed for more than a year, but to no avail. Even amid clinical trials of the drug that produced serious side effects in its patients, the FDA maintained that Crestor was safe when given to the right patients at the right dose. Though they stand behind the safety of the drug, the FDA continues to stress several key safety messages to physicians who deal with Crestor, including the importance of starting doses and continuing doses, as well as the need to inform patients about the possible health risks associated with taking Crestor. The FDA also recommends that if patients exhibit side effects such as muscle pain, fever, dark urine, nausea or vomiting, they should immediately contact their physician.
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...