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Study: Millions of Americans May Suffer Side Effects from Statins

woman in bed looking at pills on nightstand

A study revealed that cholesterol lowering drugs called statins — including the popular drug, Lipitor — may cause painful side effects in millions of Americans who take them each year.

According to the study, about 10 percent of people in the U.S. suffer muscle pain, weakness or cramping when taking a statin. This equates to about three to four million Americans. Because of the severe pain, many patients stopped therapy, putting them at increased risk of heart attack and stroke. Even when patients reported the problem, many doctors ignored the claims because of lack of evidence. Some researchers said the pain was largely psychological.

But, the new study published in JAMA at the beginning of April confirmed that these patients have a condition known as “statin intolerance.”

“We’ve confirmed that this is a problem and it’s real,” lead study author Dr. Steve Nissen said.

Nissen and colleagues studied data from the study that included about 500 people. Some patients received Pfizer’s Lipitor (atorvastatin), while others received a placebo. The study found “muscle symptoms occurred in 209 of 491 (42.6%) while taking atorvastatin (Lipitor) but not while taking placebo.”

In phase two of the trial, researchers tried alternative treatments for lowering cholesterol using new type of drug called evolocumab, a medication that belongs to the PCSK9 inhibitor class. These drugs work differently from statins and do not cause the same muscle effects. In the study, evolocumab decreased LDL-C (bad cholesterol) more than Lipitor.

The new drugs offer hope to people suffering from high cholesterol that cannot tolerate statins, but PCSK9 inhibitors have yet to acquire FDA approval and treatment could cost from $10,000 to $15,000 a year. While these findings confirmed the statin intolerance, researchers pointed out that the study involved a relatively small group and more study is needed.

Lipitor Linked to Type 2 Diabetes in Women

Statins revolutionized the way doctors treat people at risk for cardiovascular disease, and many physicians embraced the drugs. Lipitor holds the coveted title of the world’s top-selling prescription medication of all time with sales exceeding $130 billion.

Lipitor blocks enzymes in the liver that produce LDL, also known as “bad” cholesterol. This in turn helps prevent hardening of the arteries that can lead to stroke, heart attacks, chest pain and aneurysm.

But, in addition to muscle problems, Lipitor and other statins are linked to a number of other disturbing side effects such as kidney, liver and muscle damage. Now, researchers are also finding that these drugs may increase the risk for developing Type 2 diabetes — another disease that has a profound impact on health.

The risk is especially high in older women, and in 2012 the FDA included a warning on statin safety labels for Type 2 diabetes. A 2013 study published in the BMJ medical journal found a 10 to 22 percent increase in risk of developing the disease, and patients who used Lipitor had the highest risk.

An earlier Women’s Health Initiative study in 2011 by Waters et al. showed the risk could as high as 50 percent.

Women with Type 2 Diabetes File Lawsuits Against Pfizer

The issues with Type 2 diabetes led to women filing lawsuits against Lipitor’s manufacturer, Pfizer. According to lawsuits filed by otherwise healthy women with no risk for Type 2 diabetes, the drug caused them to develop the disease. Plaintiffs said Pfizer hid the risk and failed to warn the public.

Close to 3,000 lawsuits are pending in South Carolina federal court before Judge Richard M. Gregel, and several more await trial in state courts across the country.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine

12 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. Carter, A. et al. (2013, March 28). Risk of Incident Diabetes Among Patients Treated with Statins: Population Based Study. British Medical Journal. Retrieved from
  2. Goldstein, M.R. and Mascitelli, L. (2013, June ). Do Statins Cause Diabetes? Current Diabetes Reports. Retrieved from
  3. U.S. Food and Drug Administration. (2012, February). FDA Expands Advice on Statin Risks. Retrieved from
  4. Healy, M. (2012, January 10). Statins Raise Risk of Type 2 Diabetes in Older Women, Study Finds. Los Angeles Times. Retrieved from
  5. Rajpathak, S., Kumbhani, D., Crandall, J., Barzilai, N., Alderman, M. and Ridker, P. (2009, October). Statin Therapy and Risk of Developing Type 2 Diabetes: A Meta-Analysis. Diabetes Care. Retrieved from
  6. Simons, J. (2003, January 20). The $10 Billion Pill. Fortune Magazine. Retrieved from
  7. Boyles, S. (2012, January 10). Statins May Raise Diabetes Risk in Older Women. WebMD. Retrieved from
  8. Nisen, M. (2012, June 28). The 10 Best Selling Prescription Drugs in the United States. Business Insider. Retrieved from
  9. Kuepper, J. (2013, May 16). Finding the Next Big Blockbuster Drug. Retrieved from
  10. Freeman, D et al. (2001). Pravastatin and the Development of Diabetes Mellitus. Circulation. Retrieved from
  11. American Diabetes Association. (n.d.). Facts About Type 2. Retrieved from
  12. Topol, E. (2012, March 4). The Diabetes Dilemma for Statin Users. The New York Times. Retrieved from
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