Cardiovascular
Statins such as Crestor and Lipitor are drugs used to lower low-density lipoprotein (LDL or "bad") cholesterol and raise "good" cholesterol in the blood. Statins are important because cardiovascular disease is a major cause of illness and death worldwide. Elevated LDL cholesterol levels are associated with a higher risk of heart attack, stroke, and heart failure. By reducing LDL level, statins reduce these serious risks.
However, since their introduction to the market, there have been reports of serious side effects experienced by people who have taken statins. The FDA has issued warnings linking the use of statins to rhabdomyolysis (serious muscle damage) and kidney or liver damage. In 2001, the statin cerivastatin (Baycol® or Lipobay®), was withdrawn from the market because it was discovered to lead to kidney failure. Because of these risks statins are not recommended for women who are pregnant or for those with active or chronic liver disease. Over the last few years, statins have also been linked to increased risk of type 2 diabetes. Two large, nationwide statin clinical trials found 25 and 13 percent increases in the relative risk of new-onset diabetes among people taking statins to lower their cholesterol. Patients who have taken statins such as Lipitor have claimed that the manufacturers of statins such as Lipitor failed to warn them of this serious risk. Lipitor: A number of individual and class action lawsuits have been filed against Pfizer Inc. alleging that plaintiffs developed type 2 diabetes as a result of taking Lipitor. Pfizer has stated that its product labels properly warned of that risk; however, the plaintiffs claim that the label's warning language used was not clear enough. For example, prior to February 2012, the Lipitor label stated: "Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR." Although Pfizer has since updated the Lipitor label, plaintiffs claim that the label continues to fail to warn consumers of the risk of developing type 2 diabetes when using Lipitor. In February, 2014, the federal actions were transferred for consolidated pre-trial proceedings to a multidistrict litigation (MDL) in the U.S. District Court for the District of South Carolina (In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II) MDL-2502). The MDL includes 56 initial lawsuits and about 170 "tag-along" lawsuits that have been added since consolidation. A greater understanding of the diabetes risk is important since 24 million Americans take statins and about 8.3 million Americans have diabetes. Nevertheless, the American College of Cardiology has reassured statin users that the statins remaining on the market are safe and that the health benefits outweigh the risks. [1] Furberg, C. "Withdrawal of cerivastatin from the world market", Curr. Control Trials Cardiovasc. Med. 2001; 2(5_: 205-207. Published online Sep. 26, 2001. doi: 10.1186/cvm-2-5-205. Retrieved from NIH. [2] American Heart Association and American College of Cardiology Advisory ACC and AHA reassure patients about statins' effectiveness, safety. Physicians patients urged to discuss concerns side effects and options for lowering cholesterol. News Release August 30, 2001. [3] Goldfine, A. "Statins: Is It Really Time to Reasses Benefits and Risks?" N. Eng. J. Med. 2012; 366:1752-1755 (May 10, 2012). Alerts |
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