Monday, November 21, 2011

High Rate of Side Effects Damage Crestor’s Reputation

Crestor was initially developed by the Japanese pharmaceutical company Shionogi and was in-licensed to Astra-Zeneca, an international pharmaceutical company, in April 1998. The FDA approved Crestor in August 2003. Multiple clinical studies have confirmed the effectiveness of Crestor side effects in reducing LDL-C ('bad' cholesterol) and raising HDL-C ('good' cholesterol). Crestor is now treating over 4.5 million patients worldwide.Crestor belongs to a family of drugs called Statins. Statins combat cholesterol by blocking a specific enzyme in the body that synthesizes cholesterol. All Statins are accompanied by a higher risk of a dangerous and potentially fatal condition called Crestor rhabdomyolysis, but Crestor is particularly closely associated with it.
Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery Crestor diabetes.The FDA recently issued a warning that 80mg Crestor doses increase the risk of rhabdomyolysis and other muscle injuries.
In addition to generic Crestor equivalents, simvastatin is included in the combination cholesterol drugs Vytorin and Simcor.Due to the adverse side effects associated with Crestor and all Statin-containing drugs, the FDA has revised the labeling and package insert for Crestor. The new labeling highlights the importance of safe use of Crestor to reduce the risk of serious muscle toxicity.
Even when Crestor was first approved in 2003 there was controversy, with the patient advocacy group Public Citizen urging the FDA to deny its approval. When Crestor was first approved, the FDA did not approve the drug in stronger proposed doses because of serious Crestor kidney failure risks. Then in an October 29, 2004 press release, Public Citizen reported that the rate of kidney damage in Crestor patients is 75 times higher than in patients taking other cholesterol drugs. There had been 29 reports of acute kidney failure or renal insufficiency. In 2005, Public Citizen revealed that from October 1, 2003 through September 30, 2004 , the rate of rhabdomyolysis reports sent to the FDA per million prescriptions filled for Crestor (13.1 reports per million prescriptions) was 6.2 times higher than the rate for all of the other statins combined (2.1 reports per million prescriptions filled).

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