Vivelle-Dot

THE SAFETY OF ESTRADIOL TRANSDERMAL PATCH (VIVELLE DOT) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Estrogens should not be used during pregnancy.

What is the estradiol transdermal patch?

The estradiol transdermal patch is a topical patch containing an estrogen hormone known as estradiol.

What is the estradiol transdermal patch used to treat?

The estradiol transdermal patch is a prescription medication used for estrogen deficiency, prevention of osteoporosis, menopause symptoms, and menopause-associated vaginal atrophy.

How does the estradiol transdermal patch work?

Estradiol is an estrogen produced by the ovaries that is responsible for development of the female reproductive system and sex characteristics. Estradiol decreases after menopause. The patch is infused with estradiol and slowly releases it through the skin into the body of the person wearing it – this replaces hormones the menopausal woman used to make for herself.

If I am using the estradiol transdermal patch, can it harm my baby?

Large studies of infants exposed to estradiol in oral contraceptives during the first trimester found no conclusive evidence of an increased risk of birth defects. Exposure to estradiol while in the uterus has been linked to fewer masculine traits and heterosexual characteristics in male babies. Oral contraceptive exposure after 8 weeks of pregnancy may increase the risk of a female baby developing external male genitalia. Estradiol should not be used during pregnancy.

If I am using the estradiol transdermal patch and become pregnant, what should I do?

It is important to talk to your doctor if you find out you are pregnant while on this medication. Alternative medications are recommended in place of estradiol during pregnancy or in childbearing age women. The use of oral contraceptives immediately before or during pregnancy is linked to a 5% risk of visible birth defects in infants.

If I am using the estradiol transdermal patch, can I safely breastfeed my baby?

Only small amounts of estradiol enter the breast milk, with transdermal estradiol transferring even less into breast milk. The American Academy of Pediatrics states that estradiol is compatible with breastfeeding. However, breastfeeding is not recommended while on estradiol since it can decrease milk production and quality. Estradiol has been used to suppress milk production in women who do not want to breastfeed. It is important to weigh the risks versus benefits and exercise caution if taking estradiol while breastfeeding.

Progestin-only oral contraceptives are recommended in women who are breastfeeding, starting at 2 weeks after delivery. Combination progestin and estrogen oral contraceptives can be started at 6 weeks after delivery, but infants should be monitored for adequate breast milk intake and growth.

If I am using the estradiol transdermal patch, will it be more difficult to get pregnant?

Animal studies have found that high doses of estradiol can decrease ovary and testicle size, which could make it harder to get pregnant.

If I am using the estradiol transdermal patch, what should I know?

It is important to talk to your doctor if you are planning to become pregnant or find out you are pregnant while on this medication. It is recommended that you avoid estradiol during pregnancy and while breastfeeding.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of estradiol transdermal patch during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about the individual medications used to treat various conditions here.   Additional information can also be found in the resources below. 

For more information about sinecatechins during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Novartis: Vivelle Dot Patch Prescribing Information

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.