Azelaic acid

THE SAFETY OF AZELAIC ACID 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:

It is recommended to only use azelaic acid during pregnancy after weighing the risks versus benefits. There have been no human studies that have looked at the safety of azelaic acid during pregnancy, but animal studies suggest this medication is not harmful to the developing baby. Cream azelaic acid can be used while nursing, but caution is advised. The manufacturer recommends either discontinuing nursing or discontinuing gel or foam azelaic acid while nursing.

What is azelaic acid?

Azelaic acid is a medication that is taken to treat acne vulgaris and rosacea. Azelaic acid is currently available as a generic (gel only) and brand name medication. Azelaic acid is available as a cream for acne (Azelex™) or foam/gel for rosacea (Finacea™) and is applied to the face twice daily, once in the morning and once in the evening. It is available by prescription from your doctor. Azelaic acid is found naturally in whole grains and animal products and is used as an additive in food. Azelaic acid is produced by a yeast that lives on the skin. Azelaic acid is manufactured as a by-product of specific chemical reactions.

What is azelaic acid used to treat?

Azelaic acid is used to treat inflammatory facial skin conditions that cause hyperpigmentation (discoloration of the skin) such as mild to moderate inflammatory acne and inflammatory rosacea in children over 12 years old, adolescents, and adults. Rosacea is characterized by red and bumpy skin with breakouts that resemble acne. Acne vulgaris, also known as acne, is an inflammatory condition of the pilosebaceous unit (hair follicles and sebaceous gland) which causes clogged pores and inflammatory lesions on the skin of the face and upper trunk. Pregnancy can cause acne to get worse in women who had acne before becoming pregnant.

Pregnant women experience acne and rosacea as often as anyone else. You can read about common skin conditions during pregnancy here.

How does azelaic acid work?

Azelaic acid has antimicrobial and anti-inflammatory properties which can decrease clogged pores and inflammation on the skin’s surface.

If I am taking azelaic acid, can it harm my baby?

There are limited human studies or case reports that have looked at the safety of this medication in pregnancy. Animal studies show that taking oral azelaic acid during pregnancy increased the risk of adverse events in offspring. It is recommended to only use this medication during pregnancy after weighing the risks versus benefits.

Evidence from animal studies with azelaic acid:

When azelaic acid was given to rats, monkeys, and rabbits at oral doses 19 to 162 times the recommended human dose, no birth defects occurred, but there was maternal toxicity and toxicity to the developing baby. 

Evidence for the risks of azelaic acid in human babies:

It is unknown if azelaic acid crosses the human placenta. The amount of topical azelaic acid expected to be absorbed into the body is 4% of the total dose applied to the skin. Topical acne medications such as azelaic acid are often preferred as first line therapy in pregnant women and women who are nursing.

Bottom line: It is recommended to only administer this medication during pregnancy after weighing the risks versus benefits.There have been no human studies that have looked at the safety of azelaic acid during pregnancy, but animal studies suggest this medication is not harmful to the developing baby.

If I am taking azelaic acid and become pregnant, what should I do?

If you are taking azelaic acid and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am taking azelaic acid, can I safely breastfeed my baby?

It is unknown if azelaic acid passes into breast milk. Since only 4% of topical azelaic acid is expected to be absorbed into the body, it is expected that a minimal amount of this medication will be present in breast milk. The infant’s skin should not come into contact with this medication. The manufacturer recommends caution when using the cream while nursing a baby. The manufacturer recommends either discontinuing nursing or discontinuing the gel or foam forms of this medication while nursing. Gel forms of azelaic acid are estimated to have 8% absorption into the body when used topically. It is important to weigh the risks versus benefits of using this medication while nursing a baby. 

Bottom line: Caution is advised when using topical azelaic acid while nursing a baby. The manufacturer recommends either discontinuing nursing or discontinuing gel or foam azelaic acid while nursing due to a higher percentage of absorption through the skin. It is important to weigh the risks versus benefits of using this medication while nursing a baby.

If I am taking azelaic acid, will it be more difficult to get pregnant?

There have been no negative effects of azelaic acid on fertility in animal studies.

If I am taking azelaic acid, what should I know?

It is recommended to only use this medication during pregnancy after weighing the risks versus benefits.There have been no human studies that have looked at the safety of azelaic acid during pregnancy, but animal studies suggest this medication is not harmful to the developing baby.

Caution is advised when using azelaic acid cream while nursing a baby. The manufacturer recommends discontinuing gel or foam azelaic acid while nursing or discontinuing nursing while using this medication due to a higher percentage of absorption through the skin. It is important to weigh the risks versus benefits of using this medication while nursing a baby.

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

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

You may find Pregistry's expert report about acne here and reports about various skin conditions and the individual medications used to treat them here.  Additional information can also be found in the links below. 

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

American Academy of Dermatology: Rosacea

Allergan:  Azelex Prescribing Information

LEO Pharma:  Finacea Prescribing Information

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Last Updated: 12-09-2019
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.