Atorvastatin was originally synthesized in 1985, although the medication wouldn’t become known as Lipitor until 1996, when it was approved by the FDA based on four clinical trials. At the time it was developed, it fell under the Parke-Davis Company, which was acquired by Warner-Lambert and then Pfizer.
Between the time of its introduction to market in 1996 and 2012 — with Pfizer’s patent on Lipitor expiring Nov. 30, 2011 — Lipitor became the best-selling drug of all time in the world, netting more than $125 billion in sales over a 14.5-year period.
Although the benefits of statins have been asserted in several reports during the tenure of Lipitor — including one published in the medical journal Circulation: Cardiovascular Quality and Outcomes and research conducted through the Mayo Clinic — several other studies have shown links to Lipitor causing diabetes in women.
In 2004, the same Circulation medical journal showed a connection between treatment with Lipitor and unregulated blood sugar levels. In 2010, another medical journal, The Lancet, published a study illustrating the risk of type 2 diabetes in women taking Lipitor. Another study in 2011, published in the Journal of the American College of Cardiology, furthered the case by illustrating a prevalence of the diabetic condition in conjunction with Lipitor use.
The FDA released a statement in February 2012 regarding Lipitor and other statins, warning about an increased risk of developing high blood sugar levels and type 2 diabetes. The FDA indicated that the medication’s warning label would be amended to reflect this concern.
The British Medical Journal and the Journal of the American Medical Association (JAMA) have both also published studies linking an increased risk — the JAMA study specifically, published January 2013, was based on data collection across more than 160,000 post-menopausal women spread out over 40 clinical centers in America.
In recent years, the FDA has issued warnings about Lipitor and the heightened risks associated with the medication, including the connection to type 2 diabetes as well as serious muscle damage and liver and kidney damage. Within this effort, the FDA ordered Pfizer to make amendments to the medication’s label.
Several lawsuits have been filed against Pfizer as a result of patient injuries. In April 2013, several plaintiffs requested that pending and future claims be consolidated to the District of South Carolina for pretrial proceedings, calling for the creation of federal multidistrict litigation (MDL). Pfizer opposed the motion, but in February 2014 the U.S. Judicial Panel on Multidistrict Litigation agreed to a Lipitor MDL, which is comprised of more than 300 cases with more filings expected.