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Many drugs carry risks of birth defects if used by pregnant women, and drugs for skin conditions are no exception. Certain drugs that are used to treat psoriasis (a chronic condition with patches of scaly and inflamed skin) are particularly dangerous during pregnancy — so much so that women who may become pregnant should use two forms of reliable birth control when taking the drugs. Other drugs for psoriasis that have not been as clearly linked to birth defects are still best avoided out...
Many drugs carry risks of birth defects if used by pregnant women, and drugs for skin conditions are no exception. Certain drugs that are used to treat psoriasis (a chronic condition with patches of scaly and inflamed skin) are particularly dangerous during pregnancy — so much so that women who may become pregnant should use two forms of reliable birth control when taking the drugs. Other drugs for psoriasis that have not been as clearly linked to birth defects are still best avoided out of caution. Only a few psoriasis treatments are truly safe during pregnancy.
Three drugs with the highest pregnancy risks
Several psoriasis drugs carry well-established, high risks of birth defects.
Methotrexate (OTREXUP, RASUVO, TREXALL) is approved by the Food and Drug Administration (FDA) only for severe, disabling psoriasis that has not responded to other medications and non-drug treatments, such as ultraviolet (UV) light therapy.[1] The FDA has designated the drug as pregnancy category X, meaning that animal or human studies have shown evidence of fetal harm and that the risks of using the drug in pregnant women clearly outweigh any possible benefits. The risk of fetal death and birth defects are high enough with methotrexate that the FDA also has required a black-box warning on the label, the agency’s strongest possible warning, advising pregnant women to avoid the drug.
Acitretin (SORIATANE) is another pregnancy category X drug that has been approved only for severe psoriasis. Like methotrexate, it should only be used when other safer treatments have failed.[2] Acitretin is especially risky because a byproduct of the drug known to cause birth defects can stay in a woman’s body for years after she takes her last dose. Alcohol consumption can further increase the accumulation of this byproduct.
Acitretin’s label advises women capable of childbearing who take this drug to avoid alcohol, use two effective forms of birth control and take periodic pregnancy tests for three full years after stopping treatment. However, trace amounts of the dangerous byproduct may persist for an even longer time: One woman still retained detectable amounts more than four years after stopping the drug.
Tazarotene (AVAGE, FABIOR, TAZORAC), applied as a cream, gel or foam, is the third pregnancy category X drug that is approved as a treatment for psoriasis.[3] Tazarotene is related to isotretinoin (ABSORICA, AMNESTEEM, CLARAVIS, MYORISAN, ZENATANE and, previously, ACCUTANE), a pill for acne that is known to significantly increase the risk of major birth defects.
If you are a woman capable of having children, do not use acitretin; it causes severe birth defects, and harmful amounts can remain in the body for years, leading to risk in future pregnancies. Also, make sure you are using two reliable forms of birth control before, during and for one month after taking methotrexate or tazarotene.
Other drugs to avoid in pregnancy
Other psoriasis drugs have not been as clearly linked to birth defects, but evidence establishing their safety during pregnancy is limited. Therefore, women who are or may become pregnant generally should avoid these drugs unless symptoms are severe and safer options have failed.
Cyclosporine (GENGRAF, NEORAL, SANDIMMUNE), a drug approved for severe, disabling psoriasis, may increase the risk of low birth weight and premature birth.[4],[5]
Doctors also sometimes prescribe the injectable biologic drugs infliximab (INFLECTRA, REMICADE), etanercept (ENBREL, ERELZI) and adalimumab (AMJEVITA, HUMIRA) to treat moderate to severe psoriasis during pregnancy.[6] However, there have been reports of birth defects in the offspring of women using infliximab and etanercept, which may or may not have been caused by these drugs.[7] Ustekinumab (STELARA), another biologic drug, has not been studied in pregnant women.[8]
These biologic psoriasis drugs, which suppress the immune system, can cross the placenta. Therefore, infants who were exposed to these drugs in the womb should not be given live-virus vaccines, such as the MMR (measles, mumps, rubella) vaccine, during the first several months after birth because they may develop serious infections from the live viruses.[9]
Calcipotriene (DOVONEX, SORILUX) and calcitriol (VECTICAL), both derived from vitamin D, may affect fetal bone development at very high doses.[10] However, limited application of the drug as a cream over a small area is unlikely to result in harm.
Doctors sometimes prescribe tacrolimus (ASTAGRAF XL, ENVARSUS XR, PROGRAF, PROTOPIC), pimecrolimus (ELIDEL) and coal tar (many brand names) for psoriasis, but these drugs are not approved by the FDA for this use[11] (coal tar is not FDA-approved for any use). High doses of coal tar also caused birth defects in animal studies.[12]
Safer treatments
Many women see an improvement in psoriasis symptoms during pregnancy because pregnancy-related hormones contribute to changes in the immune system.[13] Emollients and moisturizers, which do not cause birth defects, may be enough to manage psoriasis for many women who have mild symptoms.[14]
Steroids applied to the skin are an option for women who have more severe symptoms. Studies have not found an increased risk of birth defects or other harms when steroids are applied to the skin during pregnancy.[15] However, very potent steroids should be avoided because they may lead to low birth weight in infants whose mothers use them during pregnancy.[16]
Ultraviolet light therapy also is generally safe to use during pregnancy. However, UV light can decrease folic acid levels, and folic acid deficiency during pregnancy is associated with certain spinal cord birth defects.[17] Women who are seeking to become pregnant should ask their doctors to test their folic acid levels during UV light therapy. All women who plan to or could become pregnant should consume 400 micrograms of folic acid daily, regardless of whether they are receiving UV light therapy.[18]
References
[1] Teva Women’s Health. Label: methotrexate (TREXALL). August 2016. https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&type=pdf&name=e942f8db-510f-44d6-acb5-b822196f5e8c. Accessed February 13, 2017.
[2] Stiefel Laboratories. Label: acitretin (SORIATANE). May 2015. https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=cec7851f-c7af-4e9e-a5e4-a585c70510d2&type=pdf&name=cec7851f-c7af-4e9e-a5e4-a585c70510d2. Accessed February 13, 2017.
[3] Allergan. Label: tazarotene gel (TAZORAC). July 2014. https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=75145c21-6ef2-455a-8a67-d48ddd4181a4&type=pdf&name=75145c21-6ef2-455a-8a67-d48ddd4181a4. Accessed February 13, 2017.
[4] Armenti VT, Ahlswede KM, Ahlswede BA, et al. National Transplantation Pregnancy Registry—Outcomes of 154 pregnancies in cyclosporine-treated female kidney transplant recipients. Transplantation. 1994;57(4):502-506.
[5] Oz B, Hackman R, Einarson T, Koren G. Pregnancy outcome after cyclosporine therapy during pregnancy: A meta-analysis. Transplantation. 2001;71(8):1051-1055.
[6] Pomeranz MK, Strober BE. Management of psoriasis in pregnancy. UpToDate.com. October 3, 2016.
[7] Carter JD, Ladhani A, Ricca LR, et al. A safety assessment of tumor necrosis factor antagonists during pregnancy: A review of the Food and Drug Administration database. J Rheumatol. 2009;36(3):635-641.
[8] Pomeranz MK, Strober BE. Management of psoriasis in pregnancy. UpToDate.com. October 3, 2016.
[9] Pomeranz MK, Strober BE. Management of psoriasis in pregnancy. UpToDate.com. October 3, 2016.
[10] Ibid.
[11] Ibid.
[12] Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation. Part I. Pregnancy. J Am Acad Dermatol. 2014;70(3)401.e1-401.e14.
[13] Murase JE, Chan KK, Garite TJ, et al. Hormonal effect on psoriasis in pregnancy and post partum. Arch Dermatol. 2005;141(5):601-606.
[14] Pomeranz MK, Strober BE. Management of psoriasis in pregnancy. UpToDate.com. October 3, 2016.
[15] Ibid.
[16] Ibid.
[17] Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation. Part I. Pregnancy. J Am Acad Dermatol. 2014;70(3)401.e1-401.e14.
[18] Centers for Disease Control and Prevention. Folic acid: Frequently asked questions. https://www.cdc.gov/ncbddd/folicacid/faqs.html. Accessed February 13, 2017.
