Warnings & Precautions
Estrogen therapy, which includes medications such as Vagifem, is closely associated with a number of different health conditions in those using hormonal treatments. Please discuss all preexisting health conditions and current medications with your doctor before beginning treatment with Vagifem, and be sure to receive regular checkups to monitor your overall health when using this medication.
High levels of estradiol within a person’s blood have been linked to an increased risk of developing breast cancer in those who are postmenopausal. As Vagifem is a vaginal insert containing estradiol, this places patients using the medication at a higher risk of breast cancer compared to those not using such products. Patients that are using Vagifem should not skip any yearly checkups involving breast exams and mammograms due to this significant risk factor.
Estrogen-only medications, such as Vagifem, have been linked to an increased risk of multiple cardiovascular conditions. This includes coronary heart disease and significant cardiovascular events such as deep vein thrombosis and stroke. Individuals with risk factors for the development of these conditions should exercise caution when using Vagifem. Some of the notable risk factors include diabetes, obesity, hypertension, tobacco use, lupus, and a family or personal history of venous thromboembolism. If any cardiovascular events are suspected or occur while using Vagifem, the patient should stop using the medication immediately.
Endometrial cancer is associated with prolonged use of estrogen therapy, such as Vagifem, in those who have a uterus. Those who use Vagifem are at a 2 to 12 times greater risk of developing endometrial cancer compared to those who do not use any form of estrogen therapy. The risks appear to increase the longer an individual uses Vagifem, and higher doses of estrogen in the body have been shown to increase this risk as well. A patient’s level of risk associated with estrogen use and endometrial cancer will remain high for up to 15 years, even after such hormone therapy has ceased.
Patients with endometriosis are likely to experience a worsening of the inflammation and pain associated with their condition when using any estrogen products, such as Vagifem. In postmenopausal patients, the natural decrease in their estrogen levels tends to alleviate the symptoms of endometriosis. However, when using this medication or any other forms of hormone therapy to manage the symptoms of low estrogen after going through menopause, this may likely reactivate the endometriosis still remaining within their bodies and contribute to the development of malignancies associated with endometriosis.
Estrogen therapy, such as the use of Vagifem, in postmenopausal patients is a risk factor in those patients developing gallbladder disease. This risk remains increased even after the medication has been discontinued.
Patients with bone metastases and breast cancer may experience severe hypercalcemia, or dangerously high levels of calcium in the blood, when using Vagifem. This is due to the fact that estrogen-based therapies, when used in patients that are postmenopausal, have these hormones impact their parathyroid function and significantly increase PTH levels, resulting in hypercalcemia.
Patients using thyroid hormone replacement therapy to manage their hypothyroidism may require adjustments to their thyroid medications to balance out the effects of Vagifem on TBG levels. Those using Vagifem while managing hypothyroidism should have their thyroid function monitored during treatment to avoid any adverse side effects.
Patients using Vagifem and other similar estrogen-related products have been shown to have an increased risk of developing ovarian cancer. The risk of ovarian cancer appears to be higher in those using it and other such products for five years or more, but the studies and their findings related to estrogen products and ovarian cancer development have not been consistent enough to provide solid statistics.
Estrogen therapies, like Vagifem, have been linked to serious eye-related conditions such as retinal vascular thrombosis (or retinal vein occlusion). Patients using such medications may experience a sudden onset of migraine, double vision, proptosis (bulging of the eyes), or a sudden loss of vision that may be partial or complete. In these instances, medical attention should be sought immediately. If a patient has developed vascular lesions or papilledema, they should stop using Vagifem indefinitely.
Worsening of Other Medical Conditions
Vagifem may also result in changes to or worsening of the following conditions:
- cardiac or renal dysfunction
- cholestatic jaundice
- hepatic hemangiomas
- hepatic impairment
- high blood pressure
Speak to your doctor about any medications or herbal supplements you are currently taking before beginning treatment with Vagifem. Discuss any concerns you may have with your doctor or a trusted pharmacist.
Drugs That Amplify the Risk of Vagifem Side Effects
These medications and substances are known to interact with Vagifem and may increase your chances of experiencing adverse Vagifem side effects:
- grapefruit juice
Drugs That May Make Vagifem Less Effective
The following medications and substances are likely to affect the metabolism of Vagifem and result in decreased efficacy or changes in the menstrual cycle:
- John’s wort
For patients who are unable to take Vagifem or experiencing significant adverse side effects, alternative medications may be used to treat some of the associated conditions for which this medication is commonly prescribed:
- Estrace (estradiol vaginal cream)
- Estring (estradiol vaginal ring)
- Femring (estradiol acetate vaginal ring)
- Premarin (conjugated estrogen tablets)
- Vagirux (estradiol hemihydrate vaginal tablets)
- Yuvafem (estradiol vaginal inserts)