Red Hot Mamas In Charge of Change.
By: Red Hot Mamas
Published: March 6, 2013
On Monday, March 4th, I made an oral presentation during the open public hearing at the FDA Advisory Committee on Reproductive Health Drugs in Washington, DC, discussing new drug applications for two non-hormonal treatment options for hot flashes.
I presented to the advisors the important unmet medical need for menopausal women to have non hormonal medicines available to control the symptoms of menopause. My presentations were well received. Unfortunately, for both medicines, the discussions emphasized the lack of efficacy compared to placebo and the potential safety problems which could be associated with these drugs. Therefore, in both cases the advisory committee voted negatively on recommending approval of these medicines.
However, we should not be discouraged. There is a great need for non-hormonal treatments for menopausal symptoms. It should be at the center of the attention of the regulators, healthcare professionals, and the pharmaceutical industry to offer these solutions to women.
Thanks to all of the women who shared so candidly about the toll their severe hot flashes were taking on their lives. I was able to read many of your stories at this public hearing emphasizing the need for help. This issue cannot be ignored. Hot flashes take a toll on our quality of life, our relationships, our work, and may create poorer health.
On a personal note as for me, I think that I may be personally responsible for global warming! I hope you will continue sharing your concerns with me. Keep writing to us on our website and our bulletin board on www.inspire.com. I’ll always be there to help you in any way.
