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 crucial to determine which products and ingredients are safe to use in pregnancy.

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

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

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

Except for the two prescription molecules, hydroquinone, which has a relatively high systemic absorption rate, and tretinoin, for which the evidence is controversial, skincare products act locally and 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.

No DermExcel™ product contains hydroquinone or tretinoin. 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.

Topical Retinoids

The amount of drug absorbed from the skin when using this product is very low; however, there are four published case reports of birth defects in the literature associated with topical tretinoin use. The role of topical retinoids in these cases remains controversial, as two 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 alone or in combination with other agents as topical treatments for acne. A surveillance study examining the oral or topical use of clindamycin reported no increased risk of malformations among 647 women with use in the first trimester. Similarly, several studies evaluating the systemic use of clindamycin in the second or third trimester of pregnancy have documented no increased rates of adverse outcomes. 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. 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 many cosmetic and acne products, and systemic absorption varies. Many extensive studies have been published in which researchers examined the outcomes of women who had taken low-dose acetylsalicylic acid during pregnancy. There was no increase in the baseline risk of adverse events, such as malformations, preterm birth, or low birth weight. Studies have been conducted on topical use in pregnancy; 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 that treat acne. Several animal studies have demonstrated adverse reproductive effects when glycolic acid is 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 commonly used to protect the skin from the sun’s harmful rays. They have been found to cause little toxicity in animals and have very limited dermal or systemic absorption. Sunscreens have also been used in pregnancy to treat or prevent melasma, and adverse events have not been reported.

self tanning agents

Dihydroxyacetone is a color additive found in self-tanning products to produce an artificial tan. Color 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

Various topical agents, such as depilatory and hair-bleaching creams, are available to address issues of hair removal or reduce the appearance of hair. 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, also found in depilatory creams, disassociates into sodium, calcium, potassium, and hydroxide ions. These ions are found abundantly in the body, and the amount of these chemicals in consumer products that 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. 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 applying high hydrogen peroxide concentrations for several hours. However, because cosmetic products such as hair-bleaching creams contain low concentrations of hydrogen peroxide, substantial amounts are unlikely to be absorbed after topical application. In addition, once absorbed, hydrogen peroxide is rapidly metabolized. Therefore, using these products during pregnancy is not expected to be a concern when done in moderation.

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 on rare occasions applied over a large surface area (40% or more of the body's surface area).

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.