Lipitor, a popular statin drug that is taken by millions of people to lower cholesterol, may be associated with an increased risk of type-2 diabetes, which is reportedly highest among post-menopausal women who use the medication.

In 2012, information about type-2 diabetes was added to the drug’s label, but plaintiffs in Lipitor diabetes lawsuits claim that the medication’s prescribing information still does not provide adequate warnings regarding this risk.

Lipitor Diabetes

Lipitor is among the best-selling prescription drugs of all time. The statin was approved for sale by the U.S. Food & Drug Administration (FDA) in 1996, and is used in conjunction with diet and exercise to lower LDL, or bad cholesterol. By 2012, Pfizer’s sales of Lipitor had exceeded $130 billion.

Statins like Lipitor have been linked to a number of serious complications, including muscle disorders, kidney problems and type-2 diabetes.

In February 2012, the FDA ordered the drugs’ manufacturers to add new warnings to their labels regarding potentially harmful effects on blood sugar levels that have the potential to lead to new-onset type-2 diabetes.

The FDA’s Lipitor diabetes warning followed the publication of a study that indicated post-menopausal women were more likely to develop diabetes if they were taking a statin drug.

Studies Link Lipitor to Type-2 Diabetes

A number of studies have linked statins, including Lipitor, to an increased risk of type-2 diabetes.

A study published in the British Medical Journal (BMJ) in May 2013 confirmed the FDA Lipitor type-2 diabetes warning in earlier research when it concluded that statins, such as Lipitor, had a higher incident of type-2 diabetes risk than pravastatin. The study analyzed patients in Canada treated with Lipitor and other statins.

The team of researchers examined the healthcare records of more than 1.5 million patients aged 66 or older without diabetes who started statin treatment between August 1997 and March 2010. Overall, a 10-22 percent increased risk of type-2 diabetes was found.

The BMJ study follows a Women’s Health Initiative study published in January 2012, which found a nearly 50 percent increase in new onset type-2 diabetes for postmenopausal women with statins compared with a placebo.

Lipitor Litigation

Lipitor lawsuits are being filed by patients who allege the blockbuster statin drug caused them to become diabetics. The controversy centers around whether the drug maker, Pfizer, sufficiently warned consumers or doctors about the possible Lipitor diabetes risk.

Plaintiffs in more than 2,000 Lipitor lawsuits pending in federal and state courts claim Pfizer should have known about the risk given 20 years of scientific research showing a potential Lipitor diabetes side effects connection.

In February 2014, these Lipitor lawsuits involving type-2 diabetes were consolidated in a federal multi district litigation (MDL) that is now underway in U.S. District Court, District of South Carolina.

All of the Lipitor lawsuit plaintiffs involved in the multidistrict litigation accuse Pfizer of failing to warn that patients treated with the statin were at an increased risk for diabetes in order to protect profits from the sale of the blockbuster drug.

A series of federal Lipitor bellwether trials are scheduled to begin in late 2015, with additional Lipitor lawsuits expected to go to trial throughout the first half of 2016, unless settlements are reached to resolve the litigation.