Statins lower a patient's blood cholesterol by reducing the amount of cholesterol the liver produces. By lowering the amount of cholesterol in the blood, statins are used to treat and prevent atherosclerosis, which can cause chest pain, heart attacks and strokes.
Common side effects of statins include headache, nausea, vomiting, constipation, diarrhea, rash, weakness and muscle pain.
Drugs in the Statin Class
Simcor (a combination of simvastatin and niacin)
Drugs that Combine a Statin with another drug
Vytorin (a combination of simvastatin and ezetimibe)
On February 28, 2012, the FDA announced that use of statins was associated with an increased risk of diabetes mellitus. Although the FDA said the risk is small, some critics argue that studies investigated by the FDA included statins that were not as potent as others. For every 167 people taking Crestor, for example, one person developed diabetes. That's compared with one in every 255 patients treated with a statin overall.
Statins and the FDA
In March 2012, the FDA announced a label change to alert patients to the risk of side effects and possible drug interactions linked to statin use. According to the FDA, there have been reports of muscle injury when statins are used with fibrates (cholesterol-lowering drugs), niacin (in large doses), Ranexa (used to treat angina) or Colchicine (used to treat gout).
The FDA also noted that there were reports of serious liver problems in patients who use statins. Although those reports are rare, the condition is serious. Symptoms of liver problems include tiredness or weakness, loss of appetite, upper abdominal pain, and dark-colored urine. Some patients have also experienced an increase in blood sugar levels.
In October 2012, the FDA announced a change to the warning label of drugs in the statin class. That change was made to alert patients to the risk of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, a rare condition that is associated with statin use. Symptoms of IMNM include proximal muscle weakness and increased serum creatine kinase, both of which can continue after statin therapy has been discontinued.
The FDA has not removed statins from the market, saying it believes the benefits of statin drugs continue to outweigh the risks.
Some statins have reportedly been linked to an increased risk of cardiomyopathy, a serious weakening of the heart muscle or a change in the structure of the heart muscle. Cardiomyopathy is associated with the heart's inability to pump blood adequately and other problems related to the function of the heart.
Statin Cardiomyopathy Risk
April 2015: A study of healthy adults conducted by Veterans Affairs researchers and published in the Journal of General Internal Medicinefound that Lipitor, Zocor and Crestor may significantly increase the risk of developing diabetes. Researchers reviewed data involving 26,000 beneficiaries of the Tricare military health system. This study was unique in that it involved people who had no history of diabetes, heart disease or severe chronic diseases.
Statin Diabetes Risk & Statin Diabetes Research
March 2015: The medical journal Diabetologia reported that a study conducted by researchers in Finland found that use of the popular cholesterol drugs like Lipitor and Zocor may increase the risk of Type 2 diabetes. More than 9,000 patients ages 45-73 were followed over a period of six years. Researchers found that the risk of Type 2 diabetes was increased by about 46 percent for those taking Lipitor and Zocor. The findings were dose-dependent, meaning that the larger the dose, the more likely a diabetes diagnosis. Further, statin treatment reduced sensitivity to insulin and reduced insulin secretion over time.
September 2014: Research published in The Lancet found that the enzyme statins designed to control cholesterol are also tied to a number of factors affecting blood sugar.
May 2014: A Canadian study published in BMJ (5/29/14) concluded that patients who are prescribed strong statins like Crestor, Zocor and Lipitor are looking at a 15 percent increased risk for diabetes within two years, when compared against patients taking statins that were considered low in potency.
February 2014: A UK study published in the European Society of Cardiology found that 3 percent of those taking statins were later diagnosed with diabetes, compared to only 2.4 percent who were given a placebo.
2006: The JUPITER study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) found that in certain patients, the risk for newly developed diabetes increased 25 percent in patients who used Crestor (a statin drug) over those who were given a placebo. Meanwhile, a meta-analysis of six statin studies showed the risk of new-onset diabetes increased by about 13 percent when patients were given a statin.
More than 2,300 Lipitor lawsuits have been filed in the District of South Carolina on behalf of individuals who allegedly developed Type 2 diabetes due to their use of the statin, according to court documents. The lawsuits claim that Pfizer knew or should have known about risks associated with their medication for years, but withheld diabetes warnings from the medical community and the public to avoid a negative impact on sales and growth of the world's best-selling ever medication.
Crestor lawsuits have been filed against AstraZeneca on behalf of former users of the statin who were diagnosed with Type 2 diabetes. Many Crestor cases are currently pending in California state court.
Several Lipitor lawsuits filed in April 2013 are seeking to consolidate all similar federal actions in the U.S. District of South Carolina. After speaking with a Lipitor diabetes lawyer in March 2013, a South Carolina woman filed a Personal Injury and Product Liability lawsuit against Pfizer. The lawsuit claims that Pfizer promoted and marketed Lipitor as safe and effective and that Pfizer did not adequately disclose this risk to its consumers. Plaintiff Evalina Smalls claims that prior to taking Lipitor she lived a healthy and proactive lifestyle. She was not overweight and had a healthy diet. But she was diagnosed with Type 2 diabetes after taking Lipitor for about ten years to decrease her risk of heart disease. (Case Number 2:2013cv00796)
See Lipitor Litigation up to October 2013
See Crestor litigation up to October 2013
Lawsuits filed by US women diagnosed with Type 2 diabetes increased from 56 to almost 1,000 in a period of five months, Reuters reported in August 2014. The diabetes lawsuits began shortly after the FDA in 2012 warned that statins, including Lipitor and Crestor, were linked to incidents of memory loss and a "small increased risk" of diabetes. Women face a higher risk than men of developing diabetes from using Lipitor, and gain fewer benefits, according to plaintiffs' lawyers.
Statin Side Effects Legal HelpIf you or a family member have taken a Statin and have experienced any side effects, please click the link below to have your Statin Side Effect claim submitted to a Drug and Medical Device attorney for further review.
Last updated on Sep-10-15