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THE SAFETY OF DAPSONE GEL 5% (ACZONE 5%) 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 MAY CAUSE HARM TO YOUR BABY:

Limited information is available on the safety of dapsone gel during pregnancy. Dapsone gel may be used on a case-by-case basis in pregnant or breastfeeding women with clear indications for use after considering the benefits to the mother and risk to the developing baby.

What is dapsone gel?

Dapsone gel is a topical antibiotic and anti-inflammatory medication.

What is dapsone gel used to treat?

Dapsone gel is used to topically treat acne on the skin in individuals older than 12 years of age. Oral dapsone is used to treat other skin conditions.

How does dapsone gel work?

Dapsone is an antibiotic that interferes with the use and production of folic acid, preventing the formation of bacterial DNA. Dapsone also has anti-inflammatory properties.

If I am taking dapsone gel, can it harm my baby?

Dapsone use during pregnancy has not been associated with birth defects. Dapsone gel is not expected to be absorbed by the developing baby or a breastfeeding infant as much as oral dapsone. The combination of dapsone with other medications during pregnancy may increase the risk of side effects and may require additional folic acid supplementation in women. Cases of hemolytic anemia and jaundice (yellowing of the skin) have been reported in some infants exposed to dapsone.

If I am taking dapsone gel and become pregnant, what should I do?

It is important that you speak with your doctor if you become pregnant while using dapsone gel. If there are clear indications for use, dapsone gel may be prescribed by your doctor during pregnancy.

If I am taking dapsone gel, can I safely breastfeed my baby?

Dapsone is expected to be excreted in breast milk. The topical form of dapsone is not expected to affect a mother’s breast milk as much as oral doses of dapsone. The American Academy of Pediatrics and the World Health Organization consider dapsone compatible with breastfeeding. It is important to weigh the risks and benefits of continuing breastfeeding while taking dapsone.

If I am taking dapsone gel, will it be more difficult to get pregnant?

No information is available related to dapsone’s effects on fertility.

If I am taking dapsone gel, what should I know?

It is important to speak with your doctor to determine if you should start or continue dapsone  therapy during pregnancy. Dapsone gel can be used during pregnancy if their are clear indications for its use and the benefits to the mother outweigh the risks to the developing baby.

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

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

You may find Pregistry's expert report about acne here,  about topical acne treatments here, and reports about the individual medications used to treat skin disorders here.   Additional information can also be found in the resources below. 

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

Allergan:  Aczone 5% Prescribing Information

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Last Updated: 22-03-2019
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.