Statins (cholesterol-lowering drugs) and the New Safety Warnings: What It Means for You

Emily Moore, BA

Statins are the most popular type of cholesterol-lowering medication and among the most widely prescribed drugs in the world, so the new FDA safety warnings are important to millions of men and women.[1] Popular brands include Lipitor, Zocor, Crestor and Vytorin. They prevent the body from making cholesterol and can help prevent heart disease and stroke. While these cholesterol-lowering medications do have important, well-established benefits, the FDA recommends that users be aware of the possible risky side effects.

In addition to previous warnings about muscle pain, the FDA has added warnings about memory loss, forgetfulness, and confusion and the increased risk of high blood sugar levels leading to the development of Type 2 diabetes. While the warning labels are new, the scientific research on the increased risk of Type 2 diabetes is not new, and we’ve been warning patients about it for some time.[2]

Several research studies have found that people who take statins, especially at high dosages, are more likely to develop  diabetes. The FDA had previously issued an alert about Crestor, one of the statins, because a clinical trial showed an unexpected 27% increase in new cases of diabetes among patients taking Crestor compared with patients who took placebos.[3] Another analysis in 2011 of five clinical trial studies found a link between the onset of diabetes and the use of high-dose statins (80 mg), compared to moderate doses of the same pills (40 mg, 20 mg, or 10 mg, depending on the study).  In all five studies, patients who had suffered acute coronary syndrome (ACS) and patients who have stable coronary heart disease were more likely to develop diabetes if they were taking higher doses of statins.[4] Acute coronary syndrome is a medical term that includes any symptoms of an insufficient blood supply to the heart muscle. In addition, a study of women who were over 55 reported that taking a statin increased the risk of a new diagnosis of diabetes.[5]

Since high doses of any statin can increase the risk of diabetes, doctors should check the blood sugar levels of a patient before starting them on treatment and put the patient on the lowest possible dose.

Memory loss, forgetfulness and confusion can occur in any age group with any statin product, according to the FDA. These symptoms were generally not serious and were reversible within a few weeks of stopping statin use. [1] For those who are experiencing “fuzzy” thinking or similar symptoms, they should consult their doctor first before stopping statins.

Muscle damage from taking a statin, especially at high doses, has been a well-known side effect of statin use. The FDA has added to their previous warnings by listing several medications that interact with one kind of statin-lovastatin, which is also known as Altroprev or Mevacor – and increase the risk of muscle damage.[1] These medications, which include erythromycin (a common antibiotic) and protease in lovastatin.

The FDA has previously warned patients about statins causing liver damage, and had previously warned patient to have blood tests to  routinely monitor their  liver enzymes.  The FDA now says that such monitoring has not been effective to prevent the rare occurrences of severe liver injury that statins can cause. [1]Instead, doctors should test liver function before starting a patient on statins, and test liver function afterwards only if the patient is displaying symptoms of liver failure. These symptoms include: jaundice (the skin becomes yellowish), bleeding easily, and a swollen belly.

For most patients with high cholesterol levels that they can’t lower to a safe level through diet and exercise, the benefits of most statins to reduce cholesterol and prevent heart disease and stroke outweigh the risks. However, the possible side effects of statins, or statins in combination with  other medications, can be serious. To find out more about different types of cholesterol-lowering medications and read a comparison of risks and benefits for particular brand name drugs, please check out Our Complete Guide to Cholesterol Medication.

1 Food and Drug Administration. Consumer Update: FDA Expands Advice on Statins Risk.27 February 2012. Retrieved athttp://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm?source=govdelivery.

2 National Research Center for Women and Families. “Our Complete Guide to Cholesterol Medication.” Accessed February 29, 2012.http://www.center4research.org/2011/08/a-guide-to-cholesterol-medication/.

3 Hlatky MA. “Expanding the orbit of primary prevention–moving beyond JUPITER”.  N. Engl. J. Med. November 2008; 359 (21): 2280-2.

4 Preiss, D.  Risk of Incident Diabetes With Intensive-Dose Compared With Moderate-Dose Statin Therapy. J Am Med. 22 Jun 2011; 305(24):2556-64.

5 Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women’s Health Initiative. Arch Intern Med. 2012;172(2):144-152.