Lipitor (sold generically as atorvastatin calcium) is Pfizer’s premier cholesterol-lowering drug. With cumulative sales exceeding $130 billion, Lipitor holds the coveted status of the world’s top-selling prescription drug of all time — but not without risks.
Lipitor is a prescription drug manufactured by pharmaceutical giant Pfizer and used to control high cholesterol levels. By lowering cholesterol, the drug aims to prevent dangerous blockages in blood flow and thereby reduce the risk of heart attack and stroke.
The U.S. Food and Drug Administration (FDA) approved Lipitor in 1996. The drug’s active ingredient is atorvastatin calcium.
Lipitor belongs to a popular class of cholesterol-lowering drugs called statins, which represent the most widely prescribed class of drugs in the U.S. Lipitor is the most popular of all statins.
Patients take statins to lower levels of cholesterol and other fatty substances in the blood that, if left unchecked, can increase the risk for heart attack, stroke and other related health complications.
The liver makes most of the cholesterol found in blood. Statins reduce the amount of cholesterol made by the liver and help the liver remove cholesterol that’s already in the blood.
Cholesterol plays a crucial role in several bodily processes that are essential to our health, but unhealthy levels of cholesterol can lead to buildup (plaque) on the walls of arteries. This can block blood flow to the brain and heart and put people at higher risk for stroke and heart disease. According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both men and women in the U.S.
Lipitor prevents heart attack and stroke by lowering cholesterol in the blood. It slows the production of cholesterol in the body therefore decreasing the amount of plaque buildup that may block the flow of blood to the heart and brain.
The FDA approved Lipitor for use in patients who may develop heart disease or who were already diagnosed with heart disease. The agency also approved the drug for use in certain teens and children.
Doctors commonly prescribe Lipitor together with diet, weight loss and exercise to help stave off cardiovascular disease in patients who may develop heart conditions. The drug can be used to reduce the risk of heart attack, stroke and chest pain for patients with multiple heart disease risk factors.
The FDA approved Lipitor for this use based on clinical trials. In one clinical trial called the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), researchers investigated Lipitor’s ability to prevent heart disease in more than 10,000 at-risk patients. The drug was found to reduce the risk of fatal or nonfatal cardiac events by 36 percent when compared with patients taking a placebo.
Lipitor is also a preventative treatment option for patients with type 2 diabetes and several risk factors for heart disease and stroke, such as hypertension, a history of smoking and two diabetes-related conditions called retinopathy and albuminuria.
Patients already diagnosed with heart disease also take the drug to lower their risk of having a cardiac event. For patients diagnosed with coronary heart disease, the drug can reduce the risk of heart attack, stroke and chest pain while also lowering the risk for heart failure surgeries and hospitalization from congestive heart failure.
Lipitor is also indicated for use in children and teenagers who are 10 to 17 years of age and have familial heterozygous hypercholesterolemia, an inherited condition in which cholesterol cannot be removed from the body normally. If diet therapy fails, Lipitor may be used in these patients to decrease the amount of cholesterol and other fatty substances in the blood.
Lipitor comes in 10, 20, 40 and 80 mg tablets to be taken by mouth. The tablets are white, oval-shaped and film-coated. The medication is usually taken once a day with or without food. It’s recommended to take Lipitor around the same time each day.
Doctors may start patients on a low dose and then slowly up the dose, not more than once every two to four weeks. The recommended starting dose is 10 to 20 mg once daily.
Lipitor comes in four sizes: 10, 20, 40 and 80mg
When taking Lipitor, it’s important to follow the exercise and dietary recommendations made by your doctor or dietitian. Typically, Lipitor users are instructed to eat a low-fat, low-cholesterol diet.
Lipitor’s drug label warns users to avoid of drinking large amounts of grapefruit juice while taking the drug. This means users should not drink more than 1.2 liters — or 1 quart — of grapefruit juice per day. Grapefruit juice contains one or more components that inhibit CYP34A, an important enzyme found in the liver, and it can increase plasma concentrations of atorvastatin.
Experts also recommend at least 30 minutes a day of moderate intensity physical activity such as brisk walking.
The vast majority of patients taking Lipitor tolerate the drug well. In premarket clinical studies, less than 2 percent of patients chose to discontinue treatment because of adverse health effects.
Urinary tract infection
Pain in extremities
Malaise (general feeling of discomfort, illness or uneasiness)
Hyperglycemia (high blood sugar)
Hepatitis (inflammation of the liver)
Tinnitus (ringing in the ears}
Although occurrences are rare, Lipitor patients have reported serious complications to their doctors and the FDA. Many of these complications can occur with all statins, which raises serious safety concerns about the drug class as a whole.
Numerous clinical studies are investigating the increased risk that Lipitor and other statins pose for diabetes, as well as damage to the kidneys, liver and muscles. The FDA also warns against use of Lipitor during pregnancy as the drug may cause harm to a fetus when administered to expectant mothers.
Patients have reported damage to liver function and fatal and non-fatal liver failure after taking Lipitor. Women have filed thousands of lawsuits against Pfizer alleging Lipitor caused their type 2 diabetes. And researchers have linked Lipitor use with muscle and joint problems, myopathy and rhabdomyolysis.
Studies indicate that diabetes risk is higher for certain groups, including the elderly, women and Asians. Researchers have concluded that those most at risk for diabetes from statin use are:
In a 2013 clinical study published in the British Medical Journal, Canadian researchers investigated the diabetes risk of six statins: Pravachol, Lipitor, Crestor, Zocor, Lescol (fluvastatin) and Mevacor (lovastatin). Among more than 470,000 patients newly treated with a statin, researchers found that the drug class is associated with a 10 to 22 percent increased risk for type 2 diabetes. Lipitor and Crestor presented the highest diabetes risk at 22 and 18 percent, respectively. Both drugs are routinely prescribed in higher potencies than other statins. There is some evidence that the diabetes risk increases with dosage.
The results of a 2012 study published in the Archives of Internal Medicine found that the diabetes risk of Lipitor and other statins is greater among post-menopausal women. Researchers drew from 12 years of clinical data that followed more than 150,000 women between the ages of 50 and 79 and determined that post-menopausal woman who took Lipitor or other statins face a 48 percent increased risk for developing type 2 diabetes compared to those who did not. The study considered several other factors also known to increase the risk for diabetes, including advanced age, obesity and lack of physical activity.
Researchers found that the risk for diabetes from statins varied among ethnicities. Asian women carried the highest risk followed by white women and Latinas. African American women experienced the lowest risk.
Because women are less likely to suffer a heart attack than men, their statin use has historically been lower. That trend changed in recent years, however. According to the Centers for Disease Control, 36 percent of women between the ages of 64 and 74 and 39 percent of those 75 and older take statins to prevent their first heart attack or a repeat cardiac event. For those age ranges, nearly 50 percent of men are taking statins.
Medical experts affirm that the benefits of Lipitor and other statins still outweigh the potential health risks for women at high risk for heart disease. However, researchers are unsure if the drug class’s benefits measure up to the diabetes risk for women taking statins who have no previous diagnosis of heart disease.
Before the FDA replaced its pregnancy risk letter categories in 2015, it had deemed Lipitor as Pregnancy Category X, indicating that the risks involved with use of the drug in pregnant women clearly outweigh the potential benefits. Pregnancy Category X means studies in animals or humans have demonstrated fetal abnormalities and/ or there is evidence of fetal risk based on human experience.
According to Lipitor’s label, the drug may cause fetal harm when administered to a pregnant woman.
“Lipitor should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards,” the drug label states. “If the woman becomes pregnant while taking LIPITOR, it should be discontinued immediately and the patient advised again as to the potential hazards to the fetus and the lack of known clinical benefit with continued use during pregnancy.”
Please seek the advice of a medical professional before making health care decisions.
Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.
Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.(888) 645-1617