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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.
Lipitor is the most popular of all statins, which represent the most widely-prescribed class of drugs in the United States. 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 U.S. Food and Drug Administration (FDA) approved Lipitor in 1996.
While Lipitor has been proven to significantly reduce the potentially life-threatening risk for cardiovascular disease faced by some patients, the statin class of medications has been associated with multiple serious side effects, including:
Lipitor prevents heart attack and stroke by lowering cholesterol 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 serious health complications.
Statins like Lipitor work by blocking HMG-CoA reductase, a liver enzyme needed to produce low-density lipoproteins (LDL), or “bad” cholesterol. By lowering the amount of LDL in the blood, Lipitor prevents atherosclerosis, a condition where plaque deposits accumulate on the inner walls of arteries, causing them to stiffen and narrow. In turn, this reduces the risk of atherosclerosis complications like heart attack, stroke, chest pain and aneurysms.
Lipitor can also raise levels of high-density lipoproteins (HDL), or “good” cholesterol, which protect against heart attack. Some experts believe that HDL can carry plaque away from arteries to the liver, which helps to slow its buildup and prevent dangerous blockages in blood flow.
Doctors commonly prescribe Lipitor 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, including advanced age, a family history of cardiovascular disease, low levels of good cholesterol (HDL), a history of smoking or hypertension. Patients already diagnosed with heart disease also take the drug to lower their risk of having a cardiac event.
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 non-fatal 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. 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.
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.
Nearly two decades after Lipitor was approved, evidence of a minimal diabetes risk from statins first emerged. Data collected from 91,000 patients treated with either a statin or a placebo revealed that 0.4 percent of statin users went on to develope diabetes, but researchers later found this figure to be inaccurate. Further studies revealed that some statins pose a higher risk for new-onset diabetes, particularly those commonly prescribed in higher potencies like Lipitor, Zocor and Crestor.
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. Additional studies indicate that diabetes risk is higher for certain groups, including the elderly, women and Asians.
Although they face a significantly lower risk for heart attack than men, statin use among women is showing a sharp incline.
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.
In a February 2012 consumer update, the FDA communicated several new health complications associated with Lipitor use, including an increased risk for high blood sugar (hyperglycemia) and the development of type 2 diabetes.
The results of a 2012 study published in the Archives of Internal Medicine found that the diabetes risk of Lipitor and other statins is significantly pronounced among post-menopausal women. Drawing from 12 years of clinical data that followed more than 150,000 women between the ages of 50 and 79, researchers determined that elderly women taking any statin face a 48 percent increased risk for diabetes compared to those who did not.
In a 2013 clinical study published in the British Medical Journal, Canadian researchers compared the diabetes risk of five popular statins to the risk of Pravachol, a statin found to significantly reduce the likelihood of developing diabetes in a previous study.
Some Lipitor patients report various types of muscle injuries after taking the drug. While the risk is minimal, researchers determined that the likelihood for muscle disease is substantially elevated among patients taking other medications in addition to Lipitor, including certain antibiotics, antifungals and treatments for HIV and hepatitis C.
The results of a 2013 study indicated that patients may face an increased risk for musculoskeletal injuries and diseases. Researchers followed nearly 14,000 U.S. soldiers and veterans taking statins and found a 19 percent greater risk for muscle and joint problems compared with nonusers. Statin users in the study were 13 percent more likely to experience strains, sprains or dislocations.
Another muscular side effect associated with Lipitor use is myopathy, a general condition where muscle tissue fibers do not function as they should. Early symptoms of myopathy include pain, weakness or tenderness of the muscles, and dark urine. These signs typically appear within the first few months of therapy.
Researchers linked a particularly severe form of myopathy called rhabdomyolysis to the use of Lipitor and other statins. In this potentially life-threatening complication, muscle tissue dies, and products of the damaged cells can enter the bloodstream. Some of these products are toxic to the kidneys and may lead to kidney failure. While rhabdomyolysis only occurs in about 0.1 percent of patients taking statins, the risk increases for patients taking certain drugs, such as macrolides.
Doctors advise against statin therapy for patients with liver problems. Clinical studies revealed that Lipitor can damage liver function, and there have been rare post-marketing reports of both fatal and non-fatal liver failure. The FDA recommends that doctors perform liver enzyme tests before statin therapy to determine whether the patient can tolerate treatment.
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.
|Other Lipitor side effects reported in clinical trials or by patients include:|
|Abdominal Discomfort||Musculoskeletal Pain||Fever|
|Blurred Vision||Memory Loss||Malaise|
Although the FDA approved Lipitor in 1996, Pfizer didn’t communicate the drug’s link to high blood sugar and increased risk for diabetes until February 2012. Nearly six months earlier, at the request of the FDA’s Division of Metabolism and Endocrinology Products, Pfizer agreed to update Lipitor’s labeling to indicate these risks.
Hundreds of Lipitor users who later developed type 2 diabetes filed legal claims against Pfizer, alleging that their illness was a direct result of treatment. They claim the drugmaker knew about or should have known about the diabetes risks of Lipitor before marketing it as a safe and effective treatment. These plaintiffs seek compensation from Pfizer, accusing the drugmaker of neglecting to adequately warn patients and doctors of the full range of Lipitor’s health risks.
In April 2013, three plaintiffs filing Lipitor lawsuits petitioned the U.S. Judicial Panel on Multidistrict Litigation to transfer all pending and future diabetes claims to a single court in the District of South Carolina for more efficient coordination. Pfizer opposed the motion to consolidate the cases into a multidistrict litigation, claiming that it would bring about lawsuits that would otherwise not be filed. In February 2014, the panel agreed to centralize the cases in South Carolina.