The makers of a statin blamed for injuries sustained by dozens of Lipitor lawsuit plaintiffs are attempting to garner approval from the U.S. Food and Drug Administration (FDA) to sell it over-the-counter, according to Forbes.com.
An article published on March 3rd indicates that clinical trials to support the application for low-dose atorvastatin have been launched by Pfizer Inc. as a means of increasing market share. The new study has been registered on ClinicalTrials.Gov and will enroll 1200 people at pharmacies in the U.S, and has been designed to help determine how many patients follow Lipitor’s directions on how to check their levels of LDL (bad cholesterol) and take the appropriate actions. According to a Pfizer executive, “It’s our responsibility to demonstrate patients can safely and effectively use these products.” The clinical trial began in October 2013.
A Wall Street Journal report indicates that Lipitor sales topped out at $2.3 billion for 2013, after losing patent protection in 2011. Before that, earnings for the drug peaked at a $13 billion in 2006.
Lipitor was approved in 1996 as a treatment for patients with high cholesterol. Since then, its popularity has continued to increase, along with concerns over a possible association with new-onset Type 2 diabetes. On February 18th, a number of Lipitor diabetes lawsuits were consolidated in the U.S. District Court, District of South Carolina on behalf of individuals who accuse Pfizer of failing to warn about the risks associated with the statin, which may have been marketed with company knowledge of its possible link to diabetes. In its decision to coordinate Lipitor lawsuits, the U.S. Judicial Panel on Multidistrict Litigation (JPML) noted that 56 claims were being transferred, but as many as 170 cases could soon join the proceeding created to eliminate duplicative discovery and inconsistent court rulings.
In January 2012, a study published in JAMA: Internal Medicine suggested that post-menopausal women may be at an especially high likelihood for developing the disease. The FDA issued a mandate the following month requiring Pfizer and other statin manufacturers to adjust drug labels to include their effects on blood sugar levels.
In May 2013, the British Medical Journal found that patients who took Lipitor were 22 percent more likely to develop new-onset diabetes.
Individuals who may have developed diabetes after taking Lipitor may be eligible to file a lawsuit against Pfizer. Call our Firm today to learn more at .