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Is It Safe to Use Topical Retinoid Medications (Tretinoin, Adapalene, Tazarotene) When Pregnant?

Speak to Your Doctor Before Using Any Topical Retinoid Medication If You Are Pregnant or Trying to Conceive

By: Dan Kern, Acne.org Founder & CSO
Last updated: July 01, 2020

The Essential Information

Doctors commonly prescribe topical retinoids (tretinoin, adapalene, tazarotene) to reduce acne. So far, there are not enough studies on topical retinoids to conclude that these products are safe to use during pregnancy. Women who are pregnant or planning to become pregnant should consult a physician before using a topical retinoid.

IMPORTANT: Women who are pregnant or planning to conceive should always speak to their doctor before using any medication, whether it be topical or oral.

The Science

Doctors commonly prescribe one of the three available topical retinoid medications--tretinoin, adapalene, or tazarotene--to patients with acne. So far, there are not enough studies on any of these to conclude that they are safe to use during pregnancy, which is why it is important for any woman who is pregnant or trying to conceive to speak to her physician before using topical retinoids.

What Are Topical Retinoids?

Retinoids are derivatives of Vitamin A that are important for proper vision and skin health.1,2 They are found in carrots, sweet potatoes, squash, and other vegetables and fruits that are red or orange. The pharmaceutical industry found that synthetically producing certain retinoids and applying them topically can also help to treat and prevent acne, and retinoids are now found in three prescription acne treatments--tretinoin, adapalene, and tazarotene.1-3

Studies have not accumulated enough evidence yet to be sure that topical retinoids products are safe to use during pregnancy

Oral Retinoids Cause Birth Defects, But What About Topical Retinoids?

The acne medication isotretinoin (Accutane®) is also a retinoid, but it is taken orally in pill form. It is well established that taking isotretinoin while pregnant drastically increases the risk of having a miscarriage, and directly causes devastating birth defects, including physical deformities, heart problems, and/or metal impairment.4

So does this mean topical retinoids are equally dangerous? No. Topical retinoids are safer to use during pregnancy than oral isotretinoin because absorption into the bloodstream through the skin is usually low.5 However, studies have not accumulated enough evidence yet to be sure that topical retinoid products are safe to use during pregnancy. This is partly due to the fact that it is ethically and legally complicated to study the effects of drugs on pregnant women.

Although a few case reports in the 1990s described birth defects after topical retinoid use, more recent studies have found no such risk.6Three recent studies have taken a look at the safety of topical retinoid use during pregnancy, and while the preponderance of data does not support a link between topical retinoids and birth defects, there were not enough participants in the studies and the evidence that came from the studies is not compelling enough to conclude that topical retinoids are in fact safe during pregnancy. Therefore, all of the researchers who conducted these studies agree that they cannot recommend topical retinoids to pregnant women.

Can Topical Retinoids Cause Birth Defects?

Expand to read details of studies

Journal of Clinical Dermatology

In a 2012 study, researchers compared 235 women who used topical retinoids during the first trimester of pregnancy to 444 women who did not use topical retinoids during the first trimester. They found that the two groups didn't have a significant difference in the number of miscarriages or birth defects.

Although the researchers found no evidence that topical retinoids caused miscarriage or birth defects, they warned that the possible risk of using these products outweighed the benefits. They concluded, "according to current knowledge, topical retinoids cannot be advised for use during pregnancy because their risk/benefit ratio remains questionable."4

This study was published in the Journal of Clinical Dermatology.4

American Journal of Dermatology

In a 2013 study, researchers evaluated the results of previous studies on topical retinoid use during pregnancy, including the 2012 study mentioned above. The researchers noted, "Topical treatments are considered the safest option during pregnancy." But they also cautioned the use of topical retinoids because of four known cases of birth defects in women who were using topical retinoids while pregnant. They added, "There have been some case reports of birth defects in babies who had prenatal exposure to topical retinoids. There have been four case reports of congenital birth defects after the use of topical tretinoin in early pregnancy."5

They concluded, "A formal consensus on the safety of topical retinoids in pregnancy is lacking and because the manufacturers advise that they should not be used during pregnancy, this treatment cannot be recommended at present."5

This study was published in the American Journal of Dermatology.5

British Journal of Dermatology

In a 2015 study, another group of researchers also evaluated the results of prior studies on topical retinoid use during pregnancy. From all the studies combined, a total of 654 pregnant women who used topical retinoids was compared to a total of 1,375 pregnant women who did not use topical retinoids. Again, they did not see an increased number of miscarriages, prematurity, or birth defects in those women who used topical retinoids during pregnancy.

In conclusion, the researchers noted, "This result may be used primarily in reassuring women who were inadvertently exposed to topical retinoids during their pregnancy." But they also cautioned that the studies are "not adequate to justify the use of topical retinoids during pregnancy" because birth defects are rare, and so far the studies only include a small sample size of pregnant women.7

This study was published in the British Journal of Dermatology.7

FDA Recommendation

The U.S. Food and Drug Administration (FDA) classifies the topical retinoids tretinoin, adapalene, and tazarotene as Pregnancy Category C drugs. This means that there is no evidence that they cause birth defects, but there is also not enough evidence to prove that they are safe to use during pregnancy.8

FDA Pregnancy Risk Categories

Recommendation by the European Medicines Agency

The European Medicines Agency gives the same recommendations as the FDA. Its guidelines state that the absorption of topical retinoids into the blood is negligible and that these medications are unlikely to harm a fetus. However, as a precaution, pregnant women and women who are planning to become pregnant should avoid topical retinoids.9

The Bottom Line

If you are pregnant, or plan to become pregnant, speak with your doctor before using a topical retinoid. In fact, it is important to speak to your doctor before you use any oral or topical medication, even if they are over-the-counter. Don't take chances, check with your physician.

References:

  1. Chivot, M. Retinoid therapy for acne. Am. J. Clin. Dermatol. 6, 13 - 19 (2005). https://www.ncbi.nlm.nih.gov/pubmed/15675886
  2. Sorg, O. & Saurat, J. H. Topical retinoids in skin aging: A focused update with reference to sun-induced epidermal vitamin a deficiency. Dermatology 228, 314 - 325 (2014). https://www.ncbi.nlm.nih.gov/pubmed/24821234
  3. Costa, C. S. & Bagatin, E. Evidence on acne therapy. Sao Paulo Med. J. 18, 193 - 197 (2013). https://www.ncbi.nlm.nih.gov/pubmed/23903269
  4. Panchaud, A. et al. Pregnancy outcome following exposure to topical retinoids: A multicenter prospective study. J. Clin. Pharmacol. 52, 1844 - 1851 (2012). https://www.ncbi.nlm.nih.gov/pubmed/22174426
  5. Meredith, F. M. & Ormerod, A. D. The management of acne vulgaris in pregnancy. Am. J. Clin. Dermatol. 14, 351 - 358 (2013). https://www.ncbi.nlm.nih.gov/pubmed/23996075
  6. Awan, S. Z & Lu, J. Management of severe acne during pregnancy: A case report and review of the literature. Int. J. Womens Dermatol. 3, 145-150 (2017). https://www.ncbi.nlm.nih.gov/pubmed/28831424
  7. Kaplan, Y. C. et al. Pregnancy outcomes following first-trimester exposure to topical retinoids: A systematic review and meta-analysis. Br. J. Dermatol. 173, 1132 - 1141 (2015). https://www.ncbi.nlm.nih.gov/pubmed/26215715
  8. Akhavan, A. & Bershad, S. Topical acne drugs: Review of clinical properties, systemic exposure, and safety. Am. J. Clin. Dermatol. 4, 473 - 492 (2003). https://www.ncbi.nlm.nih.gov/pubmed/12814337
  9. European Medicines Agency. Updated measures for pregnancy prevention during retinoid use (2018). Available from: https://www.ema.europa.eu/en/news/updated-measures-pregnancy-prevention-during-retinoid-use

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