Product Safety During Pregnancy & Breastfeeding

Many female patients complain about acne, unwanted hair growth, and other skin problems that have only developed since they became pregnant.

Women want to look their best at this important time in their lives, and therefore it's important to determine which products and ingredients are safe to use in pregnancy. 

Summary: With the exception of the 2 prescription molecules hydroquinone, which has a relatively high systemic absorption rate, and tretinoin, for which the evidence is controversial, skincare products act locally and therefore produce minimal systemic levels. Consequently, in most cases, women can deal with these cosmetically unappealing skin conditions without compromising the safety of their unborn children.

Note: No DermExcel™ product contains hydroquinone or tretinoin. Both of these active ingredients are only available by prescription from a medical doctor.  DermExcel™ Retinol serum contains an active ingredient very similar to Tretinoin. We advise customers to discontinue the use of Retinol serum until after pregnancy.

Commonly asked questions

1. Which DermExcel™ home-care products should patients avoid during pregnancy?

DermExcel™ Retinol serum 

2. Why should patients stop using Retinol if it doesn't contain one of the above prescription molecules that should be avoided during pregnancy?

Even though no evidence exists suggesting that the molecule in our Retinol serum should be avoided during pregnancy, this particular active ingredient is an ester of the prescription molecule retinoic acid, it's therefore our ethical and legal obligation to be overly cautious. 

3. How long before pregnancy should Retinol serum usage be stopped?

As soon as the patient find out she is pregnant. We only advise to stop using Retinol serum as a precaution. 

4. Is Retinol serum safe during breastfeeding?

Yes it is safe to use the DermExcel Retinol serum while breastfeeding.  

EVIDENCE:

• Because Tretinoin (the prescription molecule, remember our Retinol is an ester of the prescription molecule) is poorly absorbed after topical application, it is considered a low risk to the nursing infant. 
• Ref: Drugs and Lactation Database (Lactmed)
• Blood concentrations measured 2-48 hours following application are essentially zero. Absorption of Retin-A (Tretinoin) via topical sources is reported to be minimal, and breastmilk would likely be minimal to none.
• Ref: Dr. Thomas Hale, Medications, and Mother’s Milk
• Vitamin A and, presumably, tretinoin (all-trans retinoic acid) are natural constituents of human milk. There are no data available on the amount of all-trans retinoic acid excreted into milk after topical use. Although other retinoids are excreted (see Vitamin A), the minimal absorption that occurs after topical application of tretinoin probably precludes the detection of clinically significant amounts in breast milk from this source. Thus, use of tretinoin while breastfeeding does not appear to represent a significant risk to a nursing infant.
• Ref: Drugs in Pregnancy and Lactation: Gerald Briggs, pharmacologist at Washington State University College of Pharmacy.

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Women experience many physiologic changes during pregnancy, including increases in androgen levels. This might lead to the development or worsening of acne vulgaris and an increase in hair growth on various parts of the body.

Topical treatment options for acne often include retinoids, antibacterials, and agents such as benzoyl peroxide and salicylic acid. Other agents used to improve the appearance of the skin, or used in skin maintenance, include the following: hydroquinone found in skin-lightening agents; avobenzone, octinoxate, and oxybenxone found in sunscreens; and dihydroxyacetone found in self-tanning agents.

Common topical agents used for removing hair or reducing its appearance include salts of thioglycolic acid and sodium, calcium, and potassium hydroxide found in depilatory creams, or hydrogen peroxide found in hair-bleaching creams.

Topical Retinoids

The amount of drug absorbed from the skin when using this product is very low; however, there are 4 published case reports of birth defects in the literature associated with topical tretinoin use. The role of the topical retinoids in these cases remains controversial, as 2 prospective studies that examined use during the first trimester of pregnancy with 96 and 106 women did not find an increased risk of major malformations or evidence of retinoid embryopathy. However, until data on larger cohorts are collected, women should not be encouraged to use topical retinoids during pregnancy.

Topical Antibacterials

Clindamycin and erythromycin are used either alone or in combination with other agents as topical treatments of acne. A surveillance study examining oral or topical use of clindamycin reported no increased risk of malformations among 647 women with use in the first trimester. Similarly, there have been no increased rates in adverse outcomes documented in several studies evaluating the systemic use of clindamycin in the second or third trimester of pregnancy. Furthermore, the oral use of erythromycin in pregnancy has not been associated with teratogenicity in several thousand women.

Benzoyl Peroxide

When benzoyl peroxide is applied topically, only 5% is absorbed through the skin, and then it is completely metabolized to benzoic acid within the skin and excreted unchanged in the urine. No studies on the use of this preparation in pregnant patients have been published; however, systemic effects on a pregnant woman and her child would not be expected and therefore the use of this product during pregnancy would not be of concern.

Salicylic acid

Topical salicylic acid is an ingredient in a number of cosmetic and acne products and systemic absorption varies. A number of large studies have been published in which researchers examined the outcomes of women who had taken low-dose acetylsalicylic acid during pregnancy and there was no increase in the baseline risk of adverse events, such as major malformations, preterm birth, or low birth weight. No studies have been conducted in pregnancy on topical use; however, as such a relatively small proportion is absorbed through the skin, it is unlikely to pose any risk to a developing baby.

Glycolic acid

Glycolic acid is an alpha hydroxy acid found in many cosmetics used to treat acne. There have been several animal studies demonstrating adverse reproductive effects when glycolic acid was administered in high doses, much larger than those used in topical cosmetic products in humans. Studies examining the use of glycolic acid in human pregnancy have not been conducted; however, using topical glycolic acid during pregnancy should not be of concern, as only a minimal amount is expected to be absorbed systemically.

Hydroquinone

Hydroquinone is used clinically as a topical depigmenting agent for conditions such as chloasma and melasma, and it is used cosmetically as a skin-whitening agent. It has been estimated that 35% to 45% is systemically absorbed following topical use in humans. A single study has been published involving the use of hydroquinone during pregnancy with no increase in adverse events; however, the sample size of pregnant women was small. Based on available data, hydroquinone use during pregnancy does not appear to be associated with an increased risk of major malformations or other adverse effects. However, because of substantial absorption compared with other products, it is best to minimize exposure until further studies can confirm safety.

Sunscreens

Sunscreens are used commonly to protect the skin from the sun’s harmful rays, and have been found to cause little toxicity in animals. The products have very limited dermal or systemic absorption. Sunscreens have been used in pregnancy to treat or prevent melasma, and adverse events have not been reported.

Chemical peels

Retinol peels should be avoided during pregnancy. (See Topical Retinoids). Glycolic acid and Salicylic acid peels are generally considered safe.

Avoid Salicylic acid peels in the rare occasion where the peel is to be applied over a large surface area (40% or more of body surface area).

Self-tanning agents

Dihydroxyacetone is a color additive that is found in self-tanning products to produce an artificial tan. Colour develops following topical application owing to dihydroxyacetone binding to amino acids in the stratum corneum. These products contain dihydroxyacetone in concentrations ranging from 1% to 15%, and when applied topically, systemic levels are minimal (0.5%), therefore, use during pregnancy would not be of concern.

Topical hair removal and bleaching agents

When addressing issues of hair removal, or reducing the appearance of hair, various topical agents are available, such as depilatory and hair-bleaching creams. According to Health Canada guidelines, thioglycolic acid is permitted in depilatory products at concentrations equal to or less than 5% with a pH of 7 to 12.7.

Sodium, calcium, and potassium hydroxide, which are also found in depilatory creams, disassociate into sodium, calcium, potassium, and hydroxide ions. These ions are found abundantly in the body, and the amount of these chemicals found in consumer products that would come in contact with skin would be negligible, especially compared with the average daily dietary intake. In addition, although they might permeate the skin, the systemic absorption of these ions is minimal and therefore they do not increase serum levels and would not be considered a problem for use during pregnancy.

In an in vitro study involving human skin, hydrogen peroxide was detectable in the dermis only after the application of high hydrogen peroxide concentrations for several hours. However, because cosmetic products such as hair-bleaching creams contain low concentrations of hydrogen peroxide, it is unlikely that substantial amounts are absorbed after topical application. In addition, once absorbed, hydrogen peroxide is rapidly metabolized. Therefore, use of these products during pregnancy is not expected to be a concern when done in moderation.

Conclusion

Apart from hydroquinone (which is absorbed systemically in fairly substantial amounts and should be used very sparingly) and topical retinoids (owing to the troubling case reports), skincare products are not expected to increase the risk of malformations or other adverse effects on the developing fetus. Consequently, pregnant women can look their best without compromising the health of their unborn children.

Your doctor will be able to advise you on which topical medications are suitable for use during pregnancy and how they should be used.

Note that we strongly recommend you share every skincare product (especially the prescription and over-the-counter drug products) you’re planning to use while pregnant with your doctor and only proceed if they approve.

The information above isn’t meant to be exhaustive, but it should give you a clear idea of what’s OK to use during pregnancy and what should be avoided. We hope you’re feeling relieved that you can achieve your skincare goals during pregnancy.

References:

Bozzo P, Chua-Gocheco A, Einarson A. Safety of skin care products during pregnancy. Can Fam Physician. 2011;57(6):665–667.

Journal of Perinatology, July 2017, pages 778-781
Journal of Epidemiology and Global Health, March 2017, pages 63-70
International Journal of Women’s Dermatology, March 2017, pages 6-10
Dermatologic Therapy, July-August 2013, pages 302-311
Canadian Family Physician, June 2011, pages 665-667
Precarie International, June 2005, pages 100-101
American Journal of Clinical Dermatology, Volume 4, 2003, pages 473-492
Teratology, May 2001, pages 186-192