Specific Safety Concerns With Vagifem

Specific Vagifem Warnings and Precautions

Warnings and precautions to be aware of prior to using Vagifem include the following:
  • Studies have shown that estrogen hormone replacement therapy increases the risk of strokes and blood clots in the legs. These risks are probably quite low for Vagifem, as it is taken vaginally at a low dosage. However, your healthcare provider should make sure you are appropriately treated for any risk factors for blood clots or heart disease before you take Vagifem. These risk factors include:
  • When possible, estrogen medications (including Vagifem) should be stopped at least four weeks before many surgeries in order to help prevent blood clots.
  • Let your healthcare provider know if you have abnormal vaginal bleeding, such as heavy bleeding or bleeding between periods, while taking Vagifem, as this may be a sign of precancerous or cancerous changes in the uterus. Your healthcare provider can perform the necessary tests to rule out cancer. Of course, if you have had a hysterectomy, you are not at risk for uterine cancer.
  • Estrogen drugs may increase the risk of breast cancer. Proper screening and monitoring (as determined by your healthcare provider), such as yearly mammograms and monthly self breast exams, are recommended.
  • Women who take estrogens have an increased risk for gallbladder disease.
  • Let your healthcare provider know right away if you notice any vision changes while taking the drug. This can signal a blood clot in the retina, a possible side effect of Vagifem.
  • Estrogens can cause high blood pressure (hypertension) or high triglycerides in some women. Your healthcare provider should monitor you for these problems while you are taking Vagifem.
  • Vagifem can make uterine fibroids worse.
  • Care should be taken when inserting the Vagifem applicator, especially in women who have irritated vaginal tissues.
  • Estrogens can cause fluid retention. This can be dangerous for women with certain medical conditions, such as congestive heart failure (CHF).
  • If you have had jaundice (yellowing of the whites of the eyes or skin) due to estrogens or pregnancy, Vagifem could cause similar problems to recur. If this happens, your healthcare provider will probably advise you to stop taking the drug.
  • Estrogen medications may not be a good choice for women with liver disease, as the liver helps metabolize estrogens.
  • Giving estrogens to women with breast cancer that has spread to the bone can lead to dangerously high blood calcium levels (hypercalcemia).
  • Vagifem may interact with a number of different medications (see Vagifem Drug Interactions).
  • Vagifem should not be used during pregnancy (see Vagifem and Pregnancy).
  • The hormone in Vagifem enters the bloodstream and passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Vagifem and Breastfeeding).
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Vagifem Drug Information

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