It’s
not well known that women experience a greater number of more severe side
effects from medications than men do. Dr. Janine Clayton of the
Office of Research on Women’s Health (National Institutes of Health) recently
raised the issue after the Food and Drug Administration was evaluating a new
sleeping pill, Intermezzo. Blood tests to learn how much of the drug remains
in a user’s system the morning after taking it uncovered that men metabolized
the drug much more rapidly than women.
Until
1993, women of childbearing age were not included in new drug trials.
When the ban on use of females was lifted that year, researchers realized that
many of the “landmark” studies, including the study on aspirin use to prevent
heart disease and stroke, had not included women, leaving them to wonder
whether or not aspirin was effective for women in avoiding these conditions. Because so many drugs
were tested exclusively on men, it’s not known what the effects will be for
women until a drug reaches the market.
A study done by the Government Accountability Office found that
8 of 10 drugs removed from the market between 1997 and 2000 posed significantly
more health risks to women than men. For example, a common antihistamine (Seldane) and a
digestive aid (Propulsid) both caused dangerous heart arrhythmia in women – as
do many drugs still on the market, including antibiotics and cholesterol
medications.
But,
the opposite may also be true – certain blood pressure medications and
antibiotics appear to be more effective in women, and women typically wake up
faster from anesthesia. There are also clearly different responses to
tobacco and alcohol: women smokers are more susceptible to cancer and heart
disease than male smokers, women under 50 have higher blood alcohol content
than men of the same age after consuming the same amount of alcohol, and women
experience alcohol-related heart damage at lower levels of alcohol consumption
than men.
The
Society for Women’s Health Research has created a useful online tool, Fact
Sheet: Sex Differences in Response to Pharmaceuticals, Tobacco, Alcohol, and
Illicit Drugs: http://www.womenshealthresearch.org/site/PageServer?pagename=hs_healthfacts_dat.
And the FDA’s Center for Drug Evaluation and Research has new guidelines for
studies of new drugs, which require that studies include gender response
differences in the earliest stages of drug development.
Hopefully,
there is increased attention to the physiological differences between females
and males that may affect a range of products and dosages, among other things.
We
continue to remind decision-makers to consider the results of all laws,
research, policies, and services – and the possible disproportionate effect
they may have on women – before making a judgment or conclusion. The
results of not doing so, such as those discovered in the scientific field, may
be life-changing.