What is Lipitor?
Lipitor (generic: atorvastatin calcium) belongs to a group of drugs called HMG CoA reductase inhibitors, or “statins” that work by reducing levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of “good” cholesterol (high-density lipoprotein, or HDL). The drug is used to treat high cholesterol and lower the risk of stroke, heart attack and other heart complications in patients with type 2 diabetes, coronary artery disease (CAD) and other heart problems. Lipitor is made by Pfizer & Co., and was approved by the U.S. Food & Drug Administration (FDA) in December 1996.
What’s the Problem?
Studies have linked the use of Lipitor and other statin medications to an increased risk for type 2 diabetes, particularly in middle-aged and older women. It is believed that Pfizer failed to adequately warn consumers of this risk, which resulted in medical bills, pain and suffering, lost wages and other damages for the women who got diabetes as a result of taking Lipitor.
How Can Lipitor Cause Diabetes?
In the body, food is broken down into sugar (glucose), which travels through the bloodstream. In response, the pancreas releases insulin to reduce blood sugar levels and allow glucose to enter the body’s cells. However, in patients with type 2 diabetes, the body cannot produce enough insulin or is unable to use insulin correctly.
When this occurs, glucose can’t enter the cells and instead accumulates in the blood, resulting in a spike in blood sugar levels. High levels of sugar in the blood can cause a variety of serious health problems including organ damage and heart attack. It is believed that Lipitor can impair the function of pancreatic cells responsible for storing and releasing insulin, and may also decrease the body’s sensitivity to the hormone.
Studies Highlight Diabetes Risk for Women who Take Lipitor
A study published in the British Medical Journal (BMJ) in May 2013 found that patients treated with Lipitor had a 22% increased risk of developing type 2 diabetes compared to those who took Pravachol (generic: pravastatin), another statin drug.
Two years earlier, a study based on data from 3 large clinical trials published in the Journal of the American College of Cardiology (JACC) also suggested that patients who took high doses of Lipitor may have an increased risk of developing diabetes, particularly if they have other risk factors for the disease. The study included nearly 4,000 adult patients who did not have diabetes, but had a history of stroke. It is believed that women, including those with a healthy body mass index (BMI), face the highest risk of getting diabetes from statins.
Type 2 Diabetes Symptoms
- Increased thirst and frequent urination
- Increased hunger
- Weight loss
- Blurred vision
- Slow-healing sores or frequent infections
- Areas of darkened skin
In February 2012, the FDA issued a Drug Safety Communication warning that Lipitor and other statins may increase the risk of high blood sugar levels and type 2 diabetes, and announced that changes would be made to the drugs’ labeling to reflect this concern. According to the agency, prescribing doctors should assess patients’ blood sugar levels after initiating treatment with Lipitor or another statin.
The warning also highlighted a potential risk for liver injury, memory loss and muscle damage associated with Lipitor; however, the current litigation surrounding the drug pertains only to Pfizer’s alleged failure to warn about type 2 diabetes.
Lipitor Side Effects
Serious side effects of Lipitor may include:
- Type 2 diabetes
- Muscle damage
- Kidney failure
- Memory loss
Other, less severe side effects of Lipitor may include:
- Dark urine
- Increased thirst or hunger
- Loss of appetite
- Yellowing of the skin or eyes (jaundice)
In April 2013, a group of plaintiffs asked a panel of federal judges to consolidate all pending and future federal Lipitor lawsuits into a multidistrict litigation (MDL) in the District of South Carolina for consolidated pretrial handling. Pfizer opposed the motion to transfer, arguing that it could encourage more people to file claims. In February 2014, the panel agreed to establish the Lipitor MDL, which now includes over 2,000 cases.
Patients who developed type 2 diabetes after taking Lipitor allege that Pfizer:
- Marketed Lipitor as safe and effective, although it knew or should have known about the drug’s potential to increase the risk of high blood sugar levels and type 2 diabetes.
- Is liable for “negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, and/or sale of Lipitor.”
- Failed in its duty to monitor Lipitor’s safety.
- Engaged in overly aggressive and misleading marketing, failing to provide patients and their doctors with information that could have prevented injuries.
- Until February 2012, Lipitor’s labeling and prescribing information “never warned patients of any potential relation between changes in blood sugar levels and taking Lipitor,” and did not warn consumers of “the serious risk of developing type 2 diabetes … when using Lipitor.”
December 1996 – Approved by the FDA
December 17, 1996 – Lipitor first approved by the U.S. Food & Drug Administration (FDA).
April 2011 – Journal of the American College of Cardiology study published
April 2011 – Study published in the Journal of the American College of Cardiology (JACC) suggests that patients on high-dose regimens of Lipitor — especially women with other risk factors — face an increased risk of getting diabetes.
February 2012 – FDA warning
February 2012 – FDA warns that Lipitor and other statins may increase the risk of high blood sugar levels and type 2 diabetes.
May 2013 – BMJ study findings
May 23, 2013 – BMJ study finds a 22% increased risk for type 2 diabetes in patients treated with Lipitor compared to those who took Pravachol.
April 2013 – MDL requested
April 2013 – Plaintiffs request multidistrict litigation (MDL) for federal Lipitor lawsuits.
February 2014 – MDL established
February 2014 – Lipitor MDL established in the U.S. District Court for the District of South Carolina.
- “Lipitor New FDA Drug Approval”. CenterWatch. December 17, 1996.
- “Predictors of New-Onset Diabetes in Patients Treated With Atorvastatin”. Journal of the American College of Cardiology (JACC). April 2011.
- “FDA Expands Advice on Statin Risks”. U.S. Food & Drug Administration (FDA). February 2012.
- “Risk of incident diabetes among patients treated with statins: population based study”. British Medical Journal (BMJ). May 23, 2013.
- “Lipitor (Atorvastatin Calcium) Products Liability Litigation MDL No. 2502”. United States District Court, District of South Carolina. February 2014.
- “Lipitor Side Effects Center”. RxList. April 7, 2015.