The Institute of Safe Medication Practices (ISMP) has released the 2015 Annual QuarterWatch drug safety report, providing an overview of domestic drug-related adverse events as submitted to the U.S. Food and Drug Administration (FDA) in 2014. In it, the ISMP considered the high number of Lipitor diabetes lawsuits that have accumulated and what they may indicate about the safety of statins like Lipitor.
Lipitor (atorvastatin) belongs to a group of cholesterol-lowering drugs known as statins. Between 1996 and 2009, Lipitor grossed more than $130 billion dollars, making it the best-selling prescription drug of all time. Six years after Pfizer’s patent expired, atorvastatin is still one of the five most widely prescribed therapeutic drugs in the United States. According to IMS health data, 2014 saw over 22 million prescriptions for atorvastatin, accounting for roughly 11.4 million person-years of exposure.
It wasn’t until 2012 that the FDA warned that statins like Lipitor may increase users’ risk of diabetes. The agency’s communication arrived in the midst of several other studies investigating the diabetes and cardiovascular effects of statins in women. Lipitor lawsuits quickly began to mount, and in February 2014, the U.S. Judicial Panel on Multidistrict Litigation moved to consolidate 56 Lipitor lawsuits in a multidistrict litigation in federal court in South Carolina. Since then, the number of Lipitor lawsuits has risen to over 2,500.
The QuarterWatch report states Lipitor “has a proven clinical benefit established in mostly high-risk men where a large clinical trial showed it reduced the risk of cardiovascular events by 36%. But the chances of it benefiting any single patient were small: It took 33,000 person-years of observation to document the prevention of fewer than 60 cardiovascular events.” In the wake of FDA warnings about diabetes risks, 13 large Lipitor clinical trials were re-examined. It was determined that that statin, as a group, may increase the risk of diabetes by about 9 percent—but that figure applied only to the patients included in those studies, who overwhelmingly tended to be male. Further observational studies in women showed that Lipitor and other statins could increase diabetes risk as much as 48 percent, significantly outweighing the purported cardiovascular benefits of the drug in women.
Some legal experts project that as many as 10,000 Lipitor lawsuits could be included in the multidistrict litigation pending in South Carolina.
Consult your doctor about any health concerns you may have. If you or a loved one was diagnosed with diabetes after using a cholesterol-lowering statin such as Lipitor, contact the pharmaceutical attorneys at Lopez McHugh now to schedule a free legal consultation. You may qualify for compensation through a Lipitor diabetes lawsuit.