to act on factsfrom women and health protection Can statins cause harm? Recent warnings from health regulators in New Zealand, Australia, and the U.K. have linked menopausal symptoms, such as hot flashes. Some researchers have expressed concern Evidence for caution There is research evidence that when patients describe adverse effects, doctors often don’t statin exposure to sleep disturbances, memory problems, depression, lung problems, and about an increase in breast cancer risk associated with the combination of hormone What women need to know recognize that certain harms are caused by variations in mood, including severe irritability therapy and statins. about statins statins. This can put patients at greater risk. and aggressive behaviour. We also do not know if there are risks Here is some of what is currently known about associated with taking statins at the same Statins are a class of prescription drugs that women of reproductive age. the harms that statins can cause: Other effects time as oral contraceptives (birth control lower cholesterol. The statins currently available While some say that statins are A 2008 trial indicated an increase in pills). Since women typically take both drugs in Canada include Lipitor, Crestor, Mevacor, so safe they should be in our Miscarriages, birth defects and infant diabetes among statin users. Other for many years, this is an area where more Pravacol, Zocor and Lescol. Approximately three drinking water, there is mounting developmental delays pancreatic problems have also been noted. research is needed. million Canadians take statins daily, and the evidence that a very cautious Statin use has been linked to miscarriages statin Lipitor is the top selling pharmaceutical in approach is more appropriate. and birth defects, as well as to problems in Hormone therapy and oral contraceptives Other risks remain unknown the country. Here are some facts to infant development for breastfed babies Most research on statin use has not Most studies to date have only reported on Doctors recommend statins to lower the risk of consider.... whose mothers were taking statins. Since examined the effect of taking statins in rates of death from heart disease, but not heart disease for primary prevention (where almost half of all pregnancies are unplanned, combination with other pharmaceutical other illnesses or causes of deaths that may or patients have not experienced a heart attack or Cholesterol: The new women of reproductive age who are taking drugs. This is significant because many may not be related to statin use. In other stroke, but are thought to be at risk) and ‘disease’ statins need to be very cautious. women taking statins are post-menopausal words, we do not yet have enough published secondary prevention (where patients have already Cholesterol has received much Health Canada warns that women intending and may also be taking hormone therapy. evidence to know if there are other risks or survived a heart attack or stroke). negative press in the last few to get pregnant, those who are already Hormone therapy, like statins, has been harms associated with long-term use of statins. Statins are one of the most common drugs decades. Health information pregnant, those nursing, and those intending to shown to lower cholesterol levels in women. Health Canada keeps a database of health prescribed to women for the prevention of heart sources tell us that to prevent nurse, as well as all women of potential But recent studies have shown that it may problems that are believed to be caused by disease. Yet most of the clinical trials to assess heart disease, it is important to childbearing age, should not take statins unless actually increase the risk for heart disease. For pharmaceutical drugs. As of November 2006, their benefits and safety have focused on men. In keep our ‘bad’ cholesterol (LDL or they consult with their physicians. Recent this reason, hormone therapy is no longer there were almost 6,000 reports (half from fact, for women who have no history of heart low-density lipoprotein) low and research from the U.K. warns that all types of recommended for the prevention of heart women) of health problems believed to be disease, there is no substantial clinical trial our ‘good cholesterol’ (HDL or statins are equally risky during pregnancy. disease and only the smallest dosage for the linked to statin use; 195 of these reports evidence that statins reduce the number of heart high-density lipoprotein) high. shortest duration is recommended to relieve linked statin use with premature death. events or deaths in women of any age. But cholesterol levels are only Muscle and cognitive problems In addition, the safety profile of statin use in one of many risk factors for heart In 2001, the statin Baycol was withdrawn from women is disturbing, with links to higher risks for disease. Factors such as poverty, the market after it was linked to at least 50 miscarriages, birth defects and infant development stress, and exposure to deaths worldwide from rhabdomyolysis—a problems in women of childbearing age, and a environmental and occupational serious and potentially fatal muscle disorder. In F O R M O R E I N F O R M AT I O N … possibility that statin use may increase the risk of pollutants all play a major role 2005, Health Canada notified health practitioners Evidence for Caution: Women and Statin Use (2007) by Harriet Rosenberg breast cancer. Health Canada has warned that all as well. Even prescription and health consumers that all statins may and Danielle Allard for Women and Health Protection. statins may increase the risk for rhabdomyolysis— drugs—such as hormone therapy increase the risk for rhabdomyolysis. Crestor, in Available at: www.whp-apsf.ca a rare, but serious and potentially fatal muscle and some pain-killers—have particular, poses a risk for rhabdomyolysis, More information on reporting an adverse drug reaction is available at: disorder. And there is not yet enough evidence to been shown to have a negative particularly for Asians taking the medication. www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/reporting-declaration-eng.php#a1 know if there are other risks or harms associated effect on heart health. Other risk Health Canada further advises that those on with long-term use of statins. factors include smoking, diet, Crestor should take the lowest possible dosage. In sum, there is no high quality clinical trial weight, and family history. Based on Evidence for Caution: Women and Statin Use (2007) by Harriet Rosenberg and evidence that cholesterol lowering through statin Because there has been so Additional research, summarized in a 2008 Danielle Allard. Written by Women and Health Protection. overview, indicates problems with chronic use will benefit the majority of women who are much emphasis on a single risk muscle pain and cognitive functions, difficulty Women and Health Protection is financially supported by the Women’s Health Contribution Program, now taking these drugs. And we know that statins factor—cholesterol—it has Health Canada. The views expressed herein do not necessarily represent the views of Health Canada. carry potentially dangerous risks, particularly for almost come to be seen as a walking, weakness, and exercise intolerance. E V I D E N C E F O R C A U T I O N What to look for Recovering from statin exposure disease in itself. This is based on the notion that statement hides the real risks for specific age groups for women and men. when reading media high levels of so-called ‘bad cholesterol’ cause an of women. It is only when women reach their 80s More recent community-based Depending on a person’s increase in the amount of plaque formation in our that heart disease becomes the number one killer. research has found that there is accounts of statin symptoms, and how long arteries, which can lead to a blockage causing a heart Men, on the other hand, are much more likely to no benefit to lowering LDL research: they were taking the drug, attack or stroke. The so-called ‘good cholesterol’, on experience heart disease at an earlier age. And cholesterol in older women, and Are women specifically addressed? people who stop taking the other hand, reduces plaque build-up in the research already shows us that women experience that for women over the age of Does the research reflect a woman statins respond differently. arteries and, therefore, may reduce the risk for heart different and a wider range of symptoms for heart 50, high cholesterol levels are not like you (your age group, social Some see a complete disease. disease than men. Because women, and their linked to heart disease. Some of situation, etc.)? But this is an over-simplified model that does not doctors, may not recognize the symptoms, women these same studies indicate that reversal of their symptoms. fully explain the very complex role of cholesterol and may face more serious consequences because of a lower cholesterol levels in Are the benefits of statins For others, some of the related processes in the body. We are rarely told that faulty diagnosis. women over 50 are actually expressed in terms of how many harms caused by statins cholesterol and lipoproteins are not the same thing Women are physically different from men and linked to higher levels of cancer, people have to take the drug in may not go away when and that cholesterol is vital to the body and essential often have different social responsibilities, liver disease, mental illness and order to see an overall benefit? statin use is stopped. for normal brain function, hormone development, cell expectations and lived experiences. Women’s early death. wall structure, immune system function, nerve-muscle bodies also process drugs differently. This may be For women under the age of Is there any discussion of side Are there alternatives communication, and Vitamin D synthesis. It is also due to their hormone levels, distributions of body 50, studies have suggested a link effects in the story? to statins? critical during pregnancy and breastfeeding to ensure fat, or ways they metabolize enzymes. All of these between high cholesterol levels Is there information about the The good news is that healthy foetal and infant development. factors play an important role in a woman’s health and heart disease, but more authors and any potential conflicts of In other words, lower cholesterol is not always better. status, and in her health risks, including her risk research is needed to determine interest? Who paid for the research? some research suggests of heart disease. if cholesterol-lowering drugs, regular, moderate exercise, “Behind the scenes” on the cause Yet findings from studies that include only or such as statins, are of any If the findings seem too good to be a healthy diet and quitting of heart disease mostly men have been reported as if the results benefit. true, they just might be! smoking may have much U.S. research on hospital admissions indicates that applied equally to women. This does not make for For women who did not bigger benefits for the majority of people hospitalized for heart disease good science. No gold standard clinical trial on the already have heart disease, preventing heart disease have what is now considered normal, or even low, benefits and risks of statins has ever been independent reviews of clinical Do you think you have than lowering cholesterol cholesterol levels. While some researchers think this undertaken specifically for women. trial evidence in 2003, 2004, experienced a negative reaction levels by taking statins or means that guidelines for acceptable cholesterol 2007, and 2008 found no proof as a result of taking statins? other cholesterol-lowering levels are still too high, others argue that there are What do we know about statin use that statin use reduces deaths medication. other, more important causes of heart disease for women? from heart problems or that the Inform yourself by reading related to inflammation. We don’t know yet whether The Framingham study of the 1950s was the first number of heart attacks or other independent research on harms If you are taking statins inflammation affects women and men differently, significant research to highlight a relationship heart events was lowered. Some caused by statins. but some studies suggest that it does and that between cholesterol levels and heart disease. But information from trials even (See For more information, over) and want to stop... inflammation may be a better predictor of the study focused only on young and middle-aged suggests an increased risk of Consult your health cardiovascular problems in women. Another puzzle men, and the study authors themselves state that heart problems for some women. Discuss with your doctor how to practitioner if you are that the research has not yet solved is whether their findings do not apply to people over age 65. For women with a history of safely taper off the drug. considering discontinuing taking medication is more or less effective than Since then, many studies have examined the heart disease, reviews of clinical Ask your doctor to report your your statin medication. other approaches to treatment. relationship between cholesterol levels and heart trials did find that women taking concerns to Health Canada’s adverse It is important not to health, and looked specifically at statins and other statins had fewer deaths from drug reaction database; or consider stop taking a statin drug One size does not fit all: cholesterol-lowering drugs. But again, the findings heart attacks and fewer heart reporting your concerns directly to abruptly. Heart disease in women and men are often not relevant to women, or to women of events, but the advantage was Health Canada. This can be done by We often hear that heart disease is the number one all ages, since many of the studies focus solely on small, and there were not phoning 1-866-234-2345. killer of women in Canada. This is true. But this male participants, or do not provide data separately actually fewer deaths overall.
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