Specific Safety Concerns With Covaryx

Specific Precautions and Warnings With Covaryx

Warnings and precautions to be aware of prior to using Covaryx include the following:
  • Covaryx contains a testosterone hormone that can cause virilization (masculinization) in women. You should immediately stop taking the drug if you start to develop this problem, as it may cause permanent changes. Let your healthcare provider know if you develop signs of virilization, such as:
    • Increased body and facial hair growth
    • Absent menstrual periods
    • Male pattern baldness (even in women)
    • Deepening of the voice
    • Enlargement of the clitoris.
  • Covaryx has never been approved by the U.S. Food and Drug Administration (FDA). Therefore, there is little reassurance that Covaryx is a safe and effective treatment for menopause. However, it is important to understand that many older medications, including some important, essential medications, have never been approved by the FDA.
  • Studies have shown that estrogen hormone replacement therapy increases the risk of strokes and blood clots in the legs. In no case should Covaryx be used to prevent heart disease (see Hormone Replacement Therapy and Heart Health for more information).
  • Your healthcare provider should make sure you are appropriately treated for any heart disease risk factors (such as high blood pressure, high cholesterol, diabetes, obesity, or smoking) or blood clots before you take Covaryx.
  • For women who still have a uterus (who have not had a hysterectomy), taking Covaryx alone (without a progestin) increases the risk of endometrial cancer (cancer of the lining of the uterus). Women who still have a uterus should take Covaryx with a progestin.
  • Estrogen drugs, used with or without a progestin, 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, is recommended.
  • When possible, Covaryx should be stopped four to six 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 Covaryx, as this may be a sign of precancerous or cancerous changes in the uterus. Your healthcare provider can perform the tests necessary to rule out cancer.
  • Estrogen drugs, used with or without a progestin, seem to increase the risk of dementia. In no case should Covaryx be used to prevent or treat dementia, as it is not effective for this use.
  • Women who take estrogen have an increased risk for gallbladder disease.
  • Let your healthcare provider know right away if you notice any vision changes. This can signal a blood clot in the retina, one of the possible Covaryx side effects.
  • Covaryx can cause high blood pressure (hypertension) or high triglycerides in some women. Your healthcare provider should monitor you for these problems during treatment.
  • If you have had jaundice (yellowing of the whites of the eyes or skin) due to estrogens or pregnancy in the past, Covaryx could cause similar problems to recur. If this happens, your healthcare provider will probably advise you to stop taking the drug.
  • If you have an underactive thyroid (hypothyroidism), Covaryx may increase your body's requirement for thyroid hormones. Your healthcare provider should monitor you and adjust the dose of your thyroid medications as necessary.
  • The medication can cause fluid retention. This can cause problems for women with congestive heart failure (CHF) or kidney problems.
  • Covaryx should be used with caution in women who have low calcium levels in the blood (known medically as hypocalcemia).
  • It is not clear whether Covaryx increases the risk of ovarian cancer. Some studies have shown an increased risk, while others have not.
  • Covaryx can make endometriosis symptoms worse.
  • Covaryx can interact with a number of different medications (see Covaryx Drug Interactions).
  • The medication should not be used during pregnancy (see Covaryx and Pregnancy).
  • Covaryx does pass through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Covaryx and Breastfeeding).
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