FDA Rejects Potential Menopause Drugs to Protect Women

When it comes to menopause, women are offered few options to obtain relief from hot flashes and hormonal changes which can wreak havoc on the body.  Recently, 2 medications were introduced that offered hope for non- hormonal treatment of hot flashes.  But the U.S. Food and Drug Administration (FDA) has shot them down.  The FDA's advisory committee for reproductive health drugs found that these 2 drugs offered little benefit over a placebo, only marginally reducing hot flashes in patients.  It seems menopausal women are going to have to obtain relief elsewhere- with home remedies, herbal supplements, or hormonal therapy.  However, are menopausal women at risk for injury from existing treatments?  Is there a need for better treatments that won't cause injury

Is there a Risk of Injury to Consumers

Menopausal women are often at a loss when it comes to treating symptoms such as hot flashes.  Previously, hormonal therapy was considered a life saver.  Doctors would prescribe progesterone and estrogen to menopausal women, providing relief from hot flashes.  However, a study in 2002 entitled the Women's Health Initiative found that the increased use of these hormones could be responsible for increased cardiovascular problems and breast cancer.  This combination hormone therapy has since fallen out of favor among women concerned that they may face these serious injuries. 

Many doctors and advocates for reproductive treatments claim that there is a great need for treatments which will bring menopausal women relief without the risk for injury.  Often, these same advocates cite the ineffectiveness of home remedies and herbal treatments.  Crying out for new medications, these advocates have often pushed the FDA to investigate new medications which could provide relief to menopausal women. However, the FDA takes the strong position that they will not budge on risking injury to consumers in favor of approving only marginally effective medications.

As this continues to develop, reproductive health advocates will continue to monitor treatment options and their safety.  Had the FDA approved drugs due to the pressure of patient advocates and not according to their own safety guidelines, there is a potential that women may have faced a risk for injury. As skilled personal injury attorneys, we would rather the FDA stick to their guns and protect women from injury than to fold to pressure.