February 4, 2013

Women and Medications

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.