Will Crestor Side Effects Be Suffered With Generic Crestor?

Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, Inc., has received tentative approval from the United States Food and Drug Administration for its rosuvastatin zinc 5, 10, 20 and 40 mg tablets. Watson's rosuvastatin zinc tablets are a new salt form of AstraZeneca's Crestor (rosuvastatin calcium) tablets. AstraZeneca filed suit against Watson on October 26, 2010 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of United States patent. AstraZeneca's lawsuit resulted in a stay of final FDA approval of Watson's NDA until April 1, 2013 or until final resolution of the matter before the court, whichever occurs sooner. In other legal matters Crestor lawsuits are being filed by patients who claimed serious, in some cases fatal side effects of Crestor. In terms of the generic version, no studies have been published yet as to the risks associated with rosuvastatin zinc like there have been with the brand-name Crestor.

The new Crestor label says it may be prescribed for apparently healthy people if they are older — men 50 and over and women 60 and over — and have one risk factor like smoking or high blood pressure, along with elevated inflammation in the body indicated by the CRP test. According to the Times, an estimated 6.5 million healthy people in the U.S. could now be considered candidates for Crestor. AstraZeneca, which makes the drug, plans to launch a big advertising blitz next month touting the statin’s preventative benefits. A disturbing twist, one recent study in The Lancet found that treating healthy people with statins like Crestor could raise a person’s risk of developing Type 2 diabetes by nine percent.

Researchers looked at studies involving a total of 91,140 participants performed between 1994 and 2009. They discovered that there was about a 9% increase in the risk of type 2 diabetes among those who use statins. While they eliminated a number of other potential causes of the increased Crestor diabetes risk, they do not make a causal link between statins and diabetes, however. In 2005, the FDA issued a public health advisory to further explain the risks and benefits of Crestor. The drug now carries a new label that includes new recommended doses for patients at a higher risk of muscle damage but not for a higher risk of diabetes.