Lipitor has been shown to effectively lower cholesterol in patients at an increased risk of heart disease. However, various clinical and observational studies, some conducted decades after the drug’s release onto the market, have linked the cholesterol-lowering drug to several serious side effects and complications, including the development of Type 2 diabetes.
Lipitor, containing the active ingredient atorvastatin, belongs to a group of drugs called statins, indicated to treat high cholesterol. These drugs are commonly prescribed to patients at an increased risk for heart disease, or cardiovascular disease, including chest pain (angina), heart attack, stroke, and other heart and blood vessel problems, or cardiovascular risks associated with high cholesterol or triglyceride levels.
Not only are statins generally widely prescribed due to their proven effectiveness, but also because of their high tolerability and low likelihood of side effects.
However, some statins, especially the higher potency statins, such as Lipitor, have been linked to several serious side effects and complications, especially when taken at higher doses. Lipitor has even been found to lead to the development of Type 2 diabetes in some patients, especially women. Other serious side effects of the cholesterol-lowering drug include: Muscle disease, such as various myopathies, liver disease, central nervous system (CNS) toxicity.
In a February 2012 consumer update, the FDA communicated Lipitor’s association to an increased risk for high blood sugar (hyperglycemia) and the development of Type 2 diabetes.
This announcement came nearly two decades after the FDA approved Lipitor, and approximately two years after evidence of a minimal diabetes risk from statins first emerged.
Data collected in 2010 from 91,000 patients treated with either a statin or a placebo (dummy pill), revealed that 0.4 percent of statin users (or one in every 255 patients treated) went on to develop diabetes.
But researchers later found this figure to be inaccurate due to the study’s inclusion of weaker statins. These drugs were introduced to the market earlier than Lipitor and more comparable statins that do not carry any similar risks.
Further studies revealed that more potent statins, such as Lipitor, Zocor and Crestor, pose a higher risk for new-onset diabetes. This heightened risk was especially apparent when the statins were prescribed at higher doses.
A more recent study published in the journal Diabetologia showed that men prescribed statins such as Lipitor had a nearly 50 percent greater chance of developing diabetes after six years on the cholesterol-lowering drug compared to those who weren’t taking the drug.
The study, conducted by scientists from Finland and only including white male participants, found that statins seemed to make people more resistant to insulin’s effects. Insulin is a hormone produced by the pancreas that helps to break down blood glucose (sugar) in the body for use as energy. Additionally, statins appeared to cause the pancreas to secrete less insulin into the patients’ bloodstream.
This information followed other researchers’ suggested findings that taking statins, including Lipitor, impairs the function of special cells in the pancreas that store and release insulin. There is also evidence that statins can decrease the body’s sensitivity to insulin.
The Finnish study showed that the drug seemed to have a greater impact on the body’s insulin production and use in patients who started with the lowest, “and closest to normal,” blood glucose levels.
Type 2 diabetes occurs when the body fails to properly use or produce insulin. This is called insulin resistance. Insulin is a crucial hormone the body uses to convert food into energy. When the body is unable to use the insulin to move blood glucose (sugar) into the body’s cells where it is stored and later used for energy, a high level of sugar builds up in the blood. This condition is also called hyperglycemia.
In the beginning, the pancreas will make extra insulin to make up for the body’s resistance to the hormone. But as the disease progresses, the organ isn’t able to keep up with the added demand. It can’t make enough insulin and the blood sugar is unable to get into the fat, liver and muscle cells to be stored for energy. Therefore, normal blood glucose levels are not able to be maintained and symptoms of the disease begin to appear.
When the body is unable to use glucose in the blood for energy, it leads to symptoms of type 2 diabetes. However, these symptoms are slow to appear for most, with some people not having any signs or symptoms of the disease for many years.
Over time, usually after many years, diabetes can lead to other serious health problems with their own symptoms.
Eye disease – such as trouble seeing (especially at night), sensitivity to light and even blindness
Leg or foot amputation – due to sores and infections that can worsen over time and can cause pain and itching in other parts of the body as well
Kidney disease – the kidneys may not work as well as they used to due to high blood sugar; they may even stop working altogether
Nerve damage – this complication can result in pain, tingling, weakness and numbness, and may result in problems digesting food or trouble going to the bathroom; men may also have difficulty getting an erection
Heart disease and stroke – diabetes makes it hard to control blood pressure and cholesterol and can also interfere with proper blood flow to the legs and feet
Diabetes is a chronic (life-long) condition with no cure. The goal of early treatment is to lower blood glucose levels. Ongoing treatment typically includes medicines and lifestyle changes aimed at preventing complications of the disease.
Being active, eating healthy and controlling one’s weight are the most important ways to treat and manage Type 2 diabetes. Individuals with the disease will also need to learn how to test their blood glucose levels at home. This is usually done by pricking their finger with a small needle called a lancet, and placing a drop of blood on a test strip that is inserted into a meter, which gives a reading that tells the patient their blood sugar level. A doctor will provide a target range for blood sugar numbers that the patient will need to try stay within.
When diet and exercise alone cannot keep blood sugar levels normal, a doctor may prescribe various medicines.
Insulin is given when a patient’s blood sugar cannot be controlled by any of the other medications. It is most commonly injected under the skin using a syringe or insulin pen. There is also a form of insulin that can be inhaled.
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. Other symptoms might include muscle cramps, stiffness and spasm.
Treatments for myopathies depend on the disease and its specific cause and severity. Treatment for some neuromuscular disorders is solely supportive, primarily aimed at relieving symptoms.
A patient’s outlook with myopathy varies. Some patients are able to live normal life spans with little to no disabling effects of the disease, while others may experience severe disability with the disease becoming progressively worse and in some cases, even deadly.
Some postmarketing reports have indicated immune-mediated necrotizing myopathy (IMNM), an autoimmune (arising from and directed against a person’s own tissues) myopathy, associated with statin use. This particular myopathy is characterized by: Muscle weakness along with elevated levels of serum creatine kinase (an enzyme found in muscle and the brain — elevated levels indicate damage to the muscle or brain), persisting even after statin treatment is stopped, Muscle biopsy showing necrotizing (causing the death of tissues) myopathy without significant inflammation, Improvement usually occurs with immunosuppressive agents.
A report published in JAMA Neurology showed that marked improvement or full recovery from this type of myopathy could take up to approximately 13.5 months in over half of 32 patients with aggressive early treatment including a combination of intravenous (IV) immune globulin, corticosteroids and a steroid-sparing agent. However, 10 percent of patients showed little or no clinical improvement.
Furthermore, only one patient was able to discontinue immunotherapy. The researchers noted that long-term treatment with a steroid-sparing agent was therefore likely, with a relapse rate of over 50 percent in patients who tried to taper off or discontinue treatment.
Those with the most favorable outcomes were determined to be males who used at least two types of immunotherapy. Immunotherapy treatments have their own side effects that can sometimes be serious.
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.
In addition to general symptoms of myopathy, such as muscle weakness, tenderness, stiffness and aching, as well as decreased urine output or dark-colored urine, patients with rhabdomyolysis may also experience: Fatigue (extreme tiredness), Joint pain, Seizures, Unintentional weight gain.
Treatment includes the administration of fluids containing bicarbonate (base) to help prevent kidney damage. These fluids may be administered by IV (through a vein), although some patients may require dialysis.
Rhabdomyolysis can also lead to high potassium levels and low blood calcium levels. Both of these conditions require prompt treatment.
A patient’s outlook will depend on the extent of damage to the kidneys. People with milder cases of rhabdomyolysis can usually return to their normal activities within about a month. Others may have fatigue and muscle pain that persists long-term.
Kidney failure is also a possibility in some. This is a serious condition that can be life-threatening if not immediately and properly treated.
Doctors advise against statin therapy for patients with liver problems. Clinical studies revealed that Lipitor can damage liver function, and there have been rare postmarketing reports of both fatal and nonfatal liver failure. The FDA recommends that doctors perform liver enzyme tests before statin therapy to determine whether the patient can tolerate treatment.
If serious liver injury with clinical symptoms or jaundice occurs during Lipitor treatment, the drug should be immediately discontinued and should not be restarted at any time.
Central nervous system (CNS) toxicity was seen in dogs treated with statins. Brain hemorrhage was observed in a female dog treated with Lipitor for three months at 120 mg per day. Another female dog suffered brain hemorrhage and optic nerve vacuolation (the development of a small cavity or space containing air or fluid in the optic nerve) after 11 weeks of escalating doses of Lipitor up to 280 mg a day. And two male dogs involved in a two-year study experienced a single tonic convulsion (seizure) each, with one being treated at 10 mg a day and one at 120 mg a day.
These doses far exceed the recommended starting dose for humans at 10 to 20 mg taken once daily. The maximum human dose is 80 mg per day. Clinical testing in mice and rats used doses six to 11 times and eight to 16 times, respectively, greater than that of the maximum recommended human dose.
In February 2012, the FDA announced to the public via a safety communication that it had received reports of memory loss and confusion in patients using statins. The federal agency said that the reported events “were generally not serious and went away once the drug was no longer being taken.”
CNS toxicity, also called CNS oxygen toxicity, results from high levels of oxygen affecting the central nervous system, which consists of the brain and spinal cord. The condition’s primary cause is due to exposure to toxins (poisons), whether found in the environment or from certain substances, such as Lipitor and other statins taken in high doses.
Lipitor has also been suggested to inhibit endocrine function by interfering with cholesterol synthesis, or production, and thereby thwarting, or blunting, adrenal and/or gonadal steroid production. However, the effects of statins on male fertility have not been studied in adequate numbers of patients, according to drug labeling.
Patients taking 80 mg of Lipitor daily, who recently (within the preceding six months) had a stroke or TIA (transient ischemic attack, or “mini stroke”), were found to have a higher incidence of hemorrhagic stroke (bleeding on the brain) than those taking placebos (dummy pills) in a randomized clinical trial involving nearly 5,000 participants. The serious side effect was nonfatal in the majority of patients affected. However, some cases resulted in death.
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