Let’s talk about safety.

As with all medications, Vagifem® (estradiol vaginal inserts) isn’t right for everyone. There are some important things you should know before taking Vagifem® 10 mcg.

What is the most important information I should know about Vagifem® (an estrogen hormone)?

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Vagifem®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
  • Do not use estrogen with or without progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Using estrogen-alone may increase your chances of getting strokes or blood clots. Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with or without progestins may increase your chance of getting dementia, based on a study of women age 65 years or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem®.

The Vagifem® track record.

Vagifem® has been FDA-approved since 1999, and millions of women have been treated with Vagifem® since that time. Multiple studies have been conducted regarding its safety and effectiveness.

Who should not take Vagifem®.

Please see the Prescribing Information for more details about who should not use Vagifem®. You should not use Vagifem® if you:

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers
  • Currently have or have had blood clots
  • Had a stroke or heart attack
  • Are allergic to Vagifem® or any of its ingredients
  • Currently have or have had liver problems
  • Have been diagnosed with a bleeding disorder
  • Think you may be pregnant

What about side effects?

Vagifem® is only used locally, in the vagina; however, the risks associated with oral estrogens should be taken into account. Read about the possible side effects of Vagifem® 10 mcg in the Prescribing Information (you’ll find the Patient Information beginning on Page 8).

The most commonly reported side effects of Vagifem® included: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection. Serious but less common side effects have been reported; read about other possible side effects in the Prescribing Information (the Patient Information begins on Page 8).

The Women’s Health Initiative.

You may have heard of the Women’s Health Initiative (WHI), substudies of which spotlighted some very serious issues about estrogen therapy. Here are some things to consider with regard to those studies.

There are 2 kinds of estrogen therapy, also called hormone therapy (HT). Systemic therapy involves taking estrogen with an oral insert, patch, gel, emulsion, spray, or injection. Local estrogen therapy (LET) involves applying estrogen directly to the vagina with an insert, cream, or ring. Both types of therapy have serious warnings associated with them. The WHI focused on oral HT only. Although the study did not include LET, in the absence of comparable data, the Food and Drug Administration (FDA) stated that these risks should be assumed to be similar to other forms of estrogen treatment, such as HT.

You should review the Important Safety Information carefully with your health care provider. Talk with your health care provider about the different dosages used in each type of therapy, and about the risks and benefits of each, keeping in mind your particular family and medical history.