Statins are the largest selling class of prescription drugs on earth, and account for over 40% of all heart medications. Lipitor, for example, at over $26 billion in global sales, was the world’s biggest selling drug, manufactured by the world’s biggest drug company, Pfizer.
Because of their effectiveness in managing cholesterol levels, statins are often prescribed to lower total cholesterol in the belief that lower numbers will mean fewer heart attacks. Most people who are prescribed statins are healthy people who don’t have heart disease but who simply have high cholesterol. They will take these drugs for the rest of their lives, making statins a dream drug for the pharmaceutical companies that make them.
- Muscle pain – can also feel like weakness or extreme fatigue especially on exertion
- Liver damage – get a liver function test six weeks after starting statins, and then every 3-6 months afterwards, especially if your dosage has increased
- Digestive problems – nausea, diarrhea, or constipation may be reduced if you take the statin in the evening with a meal
- Rash or flushing – particularly common if you’re taking the statin Simcor, or a combination of a statin plus niacin
- Neurological side effects – some researchers suspect that memory loss may be linked to statin use
- Mood disorders and violent or aggressive behaviour – you won’t find these mentioned on the drug company’s package inserts, but researchers have found associations between aggressive behaviour and statin use that were not reported in clinical trials. This research* found that some statin users who had mood and memory problems also had muscle problems and weakness, which would affect their ability to undertake proven heart-protective exercise programs.
- As much as a 48% higher risk of diabetes (particularly in middle-aged or older women)
NOTE: See your physician immediately to report any of these symptoms.
If you’re experiencing severe side effects in response to taking a statin drug, here’s what you and your doctor might consider, according to Mayo Clinic cardiologists:
- Take a brief break from statin therapy. Sometimes it’s hard to tell whether the muscle aches or other problems you’re having are statin side effects or just part of the aging process. Taking a break of 10 to 14 days can give you some time to compare how you feel when you are and aren’t taking a statin. This can help you determine whether your symptoms are due to statins instead of something else.
- Switch to another statin drug. It’s possible, although unlikely, that one particular statin may cause side effects for you while another statin won’t. For example, it’s thought that simvastatin (Zocor) may be more likely to cause muscle pain as a side effect than other statins when it’s taken at high doses. Newer statin drugs are being studied that may have fewer side effects.
- Change your dose. Lowering your dose may reduce some of your side effects, but it may also reduce some of the cholesterol-lowering benefits your medication has. It’s also possible your doctor will suggest switching your medication to another statin that’s equally effective but can be taken in a lower dose. For example, if you’ve successfully taken atorvastatin (Lipitor) for a long time at higher doses, your doctor may keep you at this level. However, higher doses are not recommended if you’re new to this medication.
- Take it easy when exercising. Exercise could make your muscle aches worse. Talk to your doctor about changing your exercise routine.
- Consider other cholesterol-lowering medications. Taking ezetimibe (Zetia), a cholesterol absorption inhibitor medication, may help you avoid taking higher doses of statins. However, some researchers question the effectiveness of ezetimibe compared with statins in terms of its ability to lower your cholesterol.
- Do not try over-the-counter (OTC) pain relievers. Muscle aches caused by statins cannot be relieved with acetaminophen (Tylenol, others) or ibuprofen (Advil, Motrin IB, others) the way other muscle aches are. Don’t try an OTC pain reliever without asking your doctor first.
- Try co-enzyme Q10 supplements. Co-enzyme Q10 supplements may help to prevent statin side effects in some people, though more studies are needed to determine benefits. If you’d like to try adding co-enzyme Q10 to your treatment, talk to your doctor first to make sure the supplement won’t interact with any of your other medications.
The rationale for prescribing statin drugs, according to Dr. Harriet Rosenberg‘s report called Evidence For Caution: Women and Statin Use for the Canadian Women’s Health Network, is based on something called the cholesterol hypothesis.
This theory argues that drugs that lower total cholesterol or LDL cholesterol (often called “bad” cholesterol) or raise HDL (“good”) cholesterol will prevent heart disease.
Measurements of these improved levels is called a surrogate or intermediate endpoint, which is different from the measurement of the more important primary or hard endpoints of decreased heart disease or death – since that’s the whole point of taking a statin drug every day for the rest of your natural life.
Dr. Rosenberg explains:
“Having high LDL cholesterol is often thought of as a virtual disease state in itself.“However, cholesterol performs many vital functions in the body: it maintains cell wall structure, is crucial for hormone and Vitamin D synthesis, bile salt production and digestion, brain and neuron function. It is critical in fetal development and is an essential component of breast milk.”
She also cites one of the most in-depth reviews of women and statin trials, undertaken in 2004 by researchers Walsh and Pignone. They evaluated data from every significant clinical trial about women and cholesterol-lowering drugs (both statins and non-statin drugs). After reviewing over 1,500 articles, they concluded that for women without heart disease, lowering cholesterol does not reduce the death rate from heart disease or the overall death rate. They also noted that there is not enough evidence to know if events such as non-fatal heart attacks or strokes are reduced.
Dr. Rosenberg refers to further analysis by researchers at the Therapeutics Initiative at the University of British Columbia, who studied 10,990 women; these researchers also found no evidence that statin therapy reduced coronary events in women without heart disease. Reserchers reported:
“The coronary benefit (of statins) in primary prevention trials appears to be limited to men.”
In addition, an overview in the medical journal The Lancet (2007) also emphasized that there has never been a clinical trial showing that statin therapy is beneficial for women who don’t already have heart disease or diabetes.
Researchers question the evidence base for guidelines promoting statin use for this large population of women (75% of women statin users do not have heart disease) which is based on research which even the guideline authors say is “generally lacking” for women – and extrapolated from men’s results.
Dr. Shah Ebrahim, a professor of public health at the U.K.’s London School of Hygiene and Tropical Medicine agrees. He and his team analyzed 14 drug trials dating from 1994 to 2006 that involved a total of 34,272 patients taking statin drugs, the majority of whom had no history of heart disease. This review was prepared by the Cochrane Collaboration — an international network that collects the best available evidence at the time and summarizes it for doctors. Dr. Ebrahim’s conclusions?
“Prescribing statins to people at low risk of heart attack – for example, middle-aged women with no major risk factors other than a modest elevation in cholesterol – is both wasting money and exposing people to potential adverse effects.”
But for women who already have pre-existing heart problems, statin use according to the survey by Walsh and Pignone, has been shown to reduce coronary events and coronary death.
Since 2004, Dr. Beatrice Golomb*, a professor of medicine at the University of California, San Diego and her colleagues have been compiling information on extreme statin-related problems, including memory loss, mood disorders and violent or aggressive behaviour.
Their work has found associations between aggressive behaviour and statin use not seen in clinical trials. This research found that some statin users who had mood and memory problems also had muscle problems and weakness, which would affect their ability to undertake proven heart-protective exercise programs.
Their research has also estimated that, while clinical trials may report that only 1-7% of all statin patients experience adverse drug reactions, the number of adverse reactions with statin use may actually be closer to 15%.
So you might wonder: if statins do not help prolong women’s lives, why are so many women taking them?
And who’s most at risk for developing side effects?
Not everyone who takes a statin drug will have side effects, of course, but some may be at greater risk than others. Risk factors include:
- taking multiple medications to lower your cholesterol
- being a female
- having a smaller body frame
- being age 65 and older
- having kidney or liver disease
- having type 1 or 2 diabetes
For more useful information about intermediate (surrogate) endpoints in clinical research, read Your Health, Ball Possession, and the World Cup.
UPDATE: December 2014 – Emerging research published in the Canadian Medical Association Journal suggests that taking the antibiotic clarithromycin may be linked with dangerous side effects when paired with one of three specific statins: rosuvastatin (Crestor), pravastatin (Pravachol) or fluvastatin (Lescol).
- Women and Statins: Evidence-Based Medicine or Wishful Thinking?
- Women, Controversial Statin Guidelines, and Common Sense
- Universal Cholesterol Screening for Little Kids?
- How Merck Got Us to Spend $21 Billion On Drugs That Don’t Work
- Study: Statin Drugs Over-Prescribed for Healthy Adults
* Rosenberg H. “Women and statin use: a women’s health advocacy perspective”. Scandinavian Cardiovascular Journal. 2008 Aug;42(4):268-73.
** Criqui MH and Golomb BA 2004. “Low and lowered cholesterol and total mortality.” Journal of the American College of Cardiology 44(5): 1009-10.
WARNING: Do not start or stop any prescription drug without consulting your own physician.