Crestor Lawsuit: End Result of Chain Reaction
A February 2010 announcement by the US Food and Drug Administration (FDA) regarding the popular cholesterol-fighting drug, Crestor, may have exposed more people to dangerous Crestor side effects when the agency expanded the drug’s indications. The new approval allowed doctors to prescribe the medication to patients without a diagnosis of heart disease. Male patients over the age of 50 and female patients over 60 were merely required to exhibit an increased risk of developing heart disease. As a result, an unprecedented number of patients began treating with statins thereby exposing more people than ever before (and perhaps more people than necessary) to a wide range of Crestor side effects.
Controversy surrounds impact of JUPITER study on Crestor side effects
The agency expanded the indications based on the results of The “Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin” study (JUPITER), a study that suggested reducing the prevalence of heart disease by increasing the number of people treating with Crestor. Sponsored by AstraZeneca, maker of Crestor, JUPITER statistics were comprised based on the evaluation of 18,000 people who had no history of heart disease, but who had an elevated CRP level. The results produced a heated controversy within the medical community.
According to ABC news, Dr. Steven Nissen of the Cleveland Clinic predicted in December 2009 that FDA acceptance of JUPITER’s recommendation “[would] expand the number of Americans eligible for statin therapy by millions.” Many reputable cardiologists lauded the JUPITER study as a major medical breakthrough. Dr. Christopher Cannon of Boston’s Brigham and Women’s Hospital told ABC that the revelation came as “outstanding news for people who are at risk [for heart disease] but who would not previously known it.”
Not all doctors agreed. University of Michigan’s Dr. Lee Green and others publicly voiced their concerns about a premature call to action, compromised patient care, and subjection of countless new patients to as-of-yet unknown Crestor side effects. At the time of the ABC interviews, the measure had not yet been approved by the FDA. Less than 2 months later however, the FDA announced its approval of the JUPITER recommendations. Today, the controversy continues.
Increased exposure to Crestor side effects leads to Crestor lawsuit inquiries
Opponents of expanded use of Crestor maintain that the JUPITER study was flawed and failed to fully account for the full range of Crestor side effects which include muscle injury, cardiomyopathy, kidney damage, and most recently- diabetes. The JUPITER study sounded an early alarm bell regarding Crestor diabetes; an increased risk of 27 percent was attributed to new cases. In 2011, the condition was added to the list of serious Crestor side effects.
Ultimately, the FDA concluded that the benefits outweighed the risks. And since more people are taking Crestor than ever before, the increase in the number of people complaining of Crestor side effects comes as little surprise. However, the uptick in reports of adverse events has sparked a rise in inquiries among patients seeking to file a Crestor lawsuit.