A new report warns that doctors may need to rethink how women are being treated with cholesterol drugs, given the number of Lipitor cases involving women diagnosed with type 2 diabetes after using the popular statin-based medication.
The Institute of Safe Medication Practices (ISMP) issued its QuarterWatch Report (PDF) last week, providing an annual review of adverse event reports submitted to the FDA and other safety signals associated with medications.
In addition to adverse event reports submitted to the FDA by consumers or medical providers, when legal claims reach a drug maker they are also submitted to the FDA as adverse events.
In 2014, ISMP indicates that the FDA received notice of at least 4,727 Lipitor legal cases for diabetes, with nearly all of the claims involving women. The number exceeded all other therapeutic drugs monitored by ISMP, leading the group to indicate that there may be safety signals in the cases that merit closer attention.
Over the past few years, a growing number of women throughout the U.S. have filed product liability lawsuits alleging that Pfizer failed to adequately warn about the risk of diabetes for women from Lipitor, which is the fourth best-selling drug in the country.
All of the complaints involve similar allegations, claiming that Pfizer knew or should have known for years about the potential link between Lipitor and a diabetes risk for women, yet withheld information from consumers and the medical community while building sales for their blockbuster cholesterol treatment.
According to the ISMP report, Lipitor diabetes cases far outpaced any other drug in 2014, with 98% of those claims filed by women. No other therapeutic drug came close to the number of claims, with the Mirena IUD cases coming in a very distant second, with 721 cases filed involving reports that the birth control implant migrated out of position or perforated organs.
“These cases, however, involve allegations that have yet to be proven through this legal process. However, the underling safety question is significant,” the report notes. “Women have a lower risk of cardiovascular disease than men, and if proven to have a 2-3 times higher risk of diabetes, guidelines for treating women with cholesterol lowering drugs need to be reassessed.”
The ISMP report notes that a recent wave of studies have linked cholesterol drugs like Lipitor and Crestor, which both belong to a popular class of cholesterol drugs known as statins, to an increased risk of diabetes. The group notes that since the indications have been primarily in women, that could be the reason the connection was missed in clinical trials and earlier studies.
“Studies combining 13 previous trials of statins with more than 1,000 patients showed a 9% increased risk of diabetes,” the QuarterWatch report states. “But there was an important problem: most earlier large statin trials had a large gender imbalance, enrolling 80% or more men. When investigators re-examined one of the largest clinical studies ever conducted in women, with more than 1 million person-years of follow-up, use of a statin was associated with a 48% adjusted increased risk of diabetes.”
Lipitor Diabetes Litigation
The Lipitor litigation has emerged since FDA warnings issued in February 2012, when Pfizer and makers of other statin-based medications were required to add new information to the drug labels about the potential impact of the medications on blood glucose levels. However, many critics have suggested that the warnings are not strong enough.
In the federal court system, the Lipitor lawsuits are centralized before U.S. District Judge Richard Gergel in the District of South Carolina, where there are currently over 2,500 cases filed by women nationwide who have allege that they developed diabetes as a result of the cholesterol drug.
A small group of Lipitor cases are being prepared for early trial dates, with a complaint filed by a Colorado women scheduled to go before a jury in November.
While the outcome of this “bellwether” trial will not be binding in other cases, it will be closely watched by those involved in the litigation, as it may influence eventual Lipitor settlements for women diagnosed with type 2 diabetes after using the cholesterol drug.
If Pfizer fails to resolve the litigation, the drug maker may face hundreds of individual trials in courts throughout the United States.