Urge FDA to Remove Black Box Warning on Local, Vaginal Estrogen

The Issue

We are calling on the FDA to review and reconsider the black box warning on local vaginal estrogen therapies.

Local, vaginal estrogen therapies are the most effective way to prevent and treat GSM (the genitourinary syndrome of menopause), 

how many people it happens to 

symptoms 

chronic and progressive 

effectively manage the symptomatic effects of menopause, such as vulvar and vaginal atrophy (source: American Menopause Society). These treatments provide significant relief for women experiencing these symptoms, improving their quality of life.

However, despite the proven benefits, the FDA has had a black box warning on these products, leading to unwarranted fear and hesitance among women considering this treatment option. It's important to note that this warning is based on studies of systemic hormone therapy and not local, vaginal estrogen, making it potentially misleading for both healthcare providers and patients (source: Harvard Women's Health Watch).

As a result, many women who could greatly benefit from often miss out due to misinformation and undue apprehension. The FDA must conduct a thorough review of the evidence and reconsider the black box warning on local, vaginal estrogen therapies to ensure that women have access to accurate and unbiased information when making healthcare decisions.

We implore you to join us in signing this petition to advocate for better menopause treatment health guidelines for women, ensuring that they have access to the most effective and safe treatment options available.

 

 

2

The Issue

We are calling on the FDA to review and reconsider the black box warning on local vaginal estrogen therapies.

Local, vaginal estrogen therapies are the most effective way to prevent and treat GSM (the genitourinary syndrome of menopause), 

how many people it happens to 

symptoms 

chronic and progressive 

effectively manage the symptomatic effects of menopause, such as vulvar and vaginal atrophy (source: American Menopause Society). These treatments provide significant relief for women experiencing these symptoms, improving their quality of life.

However, despite the proven benefits, the FDA has had a black box warning on these products, leading to unwarranted fear and hesitance among women considering this treatment option. It's important to note that this warning is based on studies of systemic hormone therapy and not local, vaginal estrogen, making it potentially misleading for both healthcare providers and patients (source: Harvard Women's Health Watch).

As a result, many women who could greatly benefit from often miss out due to misinformation and undue apprehension. The FDA must conduct a thorough review of the evidence and reconsider the black box warning on local, vaginal estrogen therapies to ensure that women have access to accurate and unbiased information when making healthcare decisions.

We implore you to join us in signing this petition to advocate for better menopause treatment health guidelines for women, ensuring that they have access to the most effective and safe treatment options available.

 

 

The Decision Makers

Patrizia Cavazzoni, M.D.
Patrizia Cavazzoni, M.D.
Food and Drug Administration

Petition Updates