WHP fact sheet.sept04.qrk by f34q4h6


									                                                                                                                                                                     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.

To top