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SAN DIEGO – “Some doctors don’t treat them at all, or they undertreat because they’re afraid of prescribing anything,” said dermatologist Kelly H. Tyler, MD.
But the Food and Drug Administration’s new system of prescription drug labeling for pregnant women offers improved insight for dermatologists, and a variety of alternatives are available to commonly used dermatologic drugs that pose risks, said Dr. Tyler, who has a unique perspective on this issue: She used to practice as an ob.gyn.
In her presentation, she provided the following tips when caring for pregnant patients.
Check the prescription drug labeling for pregnant and lactating women
Prior to 2015, the FDA used a letter ratings to denote the risk of medications during pregnancy. The ratings – A, B, C, D, and X – go from “A” showing no fetal risk in controlled studies to “X” in which a drug is contraindicated because “there is no reason to risk use of drug in pregnancy.”
This rating system is problematic, Dr. Tyler said, since it’s imprecise. She noted that about two-thirds of medications have a risk rating of C, which means “Risk cannot be ruled out; human studies may or may not show risk; potential benefits may justify potential risk.” But, she asked, “How are you supposed to know what to do with that kind of information?”
By June 30, 2015, FDA had retired the letter classifications and replaced this system with the Pregnancy and Lactation Labeling final rule, which requires that labels include a pregnancy section with information on pregnancy exposure registries, in addition to risk summaries, clinical considerations, and available data. There are also sections on lactation, including nursing mothers, and females and males of reproductive potential. (This information appears in the prescription drug labeling sections 8.1-8.3.) Labels for medications approved prior to June 30, 2001 did not need to be updated. Labels for newer medications are required to comply within 3-5 years of the 2015 policy change.
Ask female patients about sexual activity
It’s important to ask all premenopausal female patients whether they’re sexually active and whether they are using birth control, trying to conceive, or are currently pregnant. If they’re pregnant, what trimester are they in?
Keep in mind, she said, that women can be pregnant for quite some time without knowing it. Home pregnancy tests may not show positive results for up to 5 weeks after conception, she said. But the embryonic/organogenesis stage – from 2 to 8 weeks – is the most important period for a pregnant mother avoid drugs that could damage the unborn child and is “when you want to avoid most medications,” she said.
Risks don’t end after a few months, however. Dr. Tyler urged dermatologists to keep in mind that the brain, teeth, and bones remain susceptible to damage from teratogenic medications after the eighth week.
Keep topical medications in mind
When it comes to pregnant women, “for most dermatologic therapies, topical medications will be your No. 1 choice” because of less absorption, Dr. Tyler said.
But there are exceptions, she noted. In acne and rosacea, for example, there’s controversy about the safety of topical retinoids. “I would just urge you to not use those medications in pregnancy because you don’t really need to use them,” Dr. Tyler said. “You have other options that are safer.”
Adapalene and tretinoin are listed as category C (risk cannot be ruled out in pregnancy) and topical tazarotene is category X (contraindicated in pregnancy) because of retinoid-like anomalies in animal studies, she said.
Avoid 3 major contraindicated systemic drugs
Isotretinoin, acitretin, and methotrexate are “absolutely contraindicated” for anyone who is pregnant or could become pregnant, Dr. Tyler said.
Use some systemic drugs with caution
Tetracyclines are category D (positive evidence of risk to human fetus, but benefits may outweigh risks of drug) with the highest risk in the second and third trimesters, Dr. Tyler said. “If for some reason you have a patient who’s on tetracycline, stop before she’s in her second trimester.”
She recommended avoiding the antibiotic erythromycin because of studies hinting at risks when used early in pregnancy. Spironolactone is theoretically risky after the week 8 of pregnancy, she said. “Because of the animal studies, we typically do not use this during pregnancy.”
Psoriasis often improves during pregnancy
Psoriasis improves during pregnancy in about half of women with psoriasis and worsens in about 20%, Dr. Tyler said. During pregnancy, topical treatments are the first-line treatment, said Dr. Tyler, who recommends that treatment should begin with topical steroids, then calcipotriene or tacrolimus if needed (J Am Acad Dermatol. 2013 Apr;68[4]:663-71). Cyclosporine is an option, as is phototherapy, she said. In an interview, she noted that phototherapy (narrowband UVB) would be considered next-line therapy in patients who are past the first 28 days of gestation and have failed topical therapy, given they are taking adequate folic acid supplementation, which is present in prenatal vitamins.
“As for biologics, you have to go with older ones that have more data. When we look at newer medications, we don’t know a lot about them,” she said during the presentation.
It’s okay to prescribe oral steroids and antihistamines
Oral steroids are safe during pregnancy, Dr. Tyler said, but “just be judicious” with moderate doses and short durations.
Antihistamines are also appropriate, she said, but be aware of the potential for neonatal sedation during lactation.
As for antibiotics for bacterial infections, azithromycin, penicillins, and cephalosporins are all category B (no risk to human fetus despite possible animal risk; or no risk in animal studies and human studies not done), as are all topical antibiotics except dapsone, which is category C because of a theoretical risk of neonatal hyperbilirubinemia if used near the time of delivery.
Hydroxychloroquine may be appropriate for connective tissue disease, she said, although steroids may be a better option in some cases.
And topical antifungals are considered safer for fungal diseases than systemic medications. She said she prefers clotrimazole and oxiconazole, both category B.
Finally, Dr. Tyler recommended permethrin (category B) for parasitic infections since it has been used extensively in pregnancy without a sign of risk and is the preferred treatment for scabies. It’s a better option than ivermectin, she said.
Postpone surgery until at least the second trimester
If it’s not possible to delay nonemergent dermatologic surgery until after pregnancy, she recommended performing procedures during the second trimester. Destruction of local lesions, however, is safe without anesthesia.
“In summary,” when treating pregnant patients, Dr. Tyler said, “a conservative approach is always best, topical medications are always first-line for any condition, and certain oral medications are safe.”
Dr. Tyler reported no relevant disclosures.
SAN DIEGO – “Some doctors don’t treat them at all, or they undertreat because they’re afraid of prescribing anything,” said dermatologist Kelly H. Tyler, MD.
But the Food and Drug Administration’s new system of prescription drug labeling for pregnant women offers improved insight for dermatologists, and a variety of alternatives are available to commonly used dermatologic drugs that pose risks, said Dr. Tyler, who has a unique perspective on this issue: She used to practice as an ob.gyn.
In her presentation, she provided the following tips when caring for pregnant patients.
Check the prescription drug labeling for pregnant and lactating women
Prior to 2015, the FDA used a letter ratings to denote the risk of medications during pregnancy. The ratings – A, B, C, D, and X – go from “A” showing no fetal risk in controlled studies to “X” in which a drug is contraindicated because “there is no reason to risk use of drug in pregnancy.”
This rating system is problematic, Dr. Tyler said, since it’s imprecise. She noted that about two-thirds of medications have a risk rating of C, which means “Risk cannot be ruled out; human studies may or may not show risk; potential benefits may justify potential risk.” But, she asked, “How are you supposed to know what to do with that kind of information?”
By June 30, 2015, FDA had retired the letter classifications and replaced this system with the Pregnancy and Lactation Labeling final rule, which requires that labels include a pregnancy section with information on pregnancy exposure registries, in addition to risk summaries, clinical considerations, and available data. There are also sections on lactation, including nursing mothers, and females and males of reproductive potential. (This information appears in the prescription drug labeling sections 8.1-8.3.) Labels for medications approved prior to June 30, 2001 did not need to be updated. Labels for newer medications are required to comply within 3-5 years of the 2015 policy change.
Ask female patients about sexual activity
It’s important to ask all premenopausal female patients whether they’re sexually active and whether they are using birth control, trying to conceive, or are currently pregnant. If they’re pregnant, what trimester are they in?
Keep in mind, she said, that women can be pregnant for quite some time without knowing it. Home pregnancy tests may not show positive results for up to 5 weeks after conception, she said. But the embryonic/organogenesis stage – from 2 to 8 weeks – is the most important period for a pregnant mother avoid drugs that could damage the unborn child and is “when you want to avoid most medications,” she said.
Risks don’t end after a few months, however. Dr. Tyler urged dermatologists to keep in mind that the brain, teeth, and bones remain susceptible to damage from teratogenic medications after the eighth week.
Keep topical medications in mind
When it comes to pregnant women, “for most dermatologic therapies, topical medications will be your No. 1 choice” because of less absorption, Dr. Tyler said.
But there are exceptions, she noted. In acne and rosacea, for example, there’s controversy about the safety of topical retinoids. “I would just urge you to not use those medications in pregnancy because you don’t really need to use them,” Dr. Tyler said. “You have other options that are safer.”
Adapalene and tretinoin are listed as category C (risk cannot be ruled out in pregnancy) and topical tazarotene is category X (contraindicated in pregnancy) because of retinoid-like anomalies in animal studies, she said.
Avoid 3 major contraindicated systemic drugs
Isotretinoin, acitretin, and methotrexate are “absolutely contraindicated” for anyone who is pregnant or could become pregnant, Dr. Tyler said.
Use some systemic drugs with caution
Tetracyclines are category D (positive evidence of risk to human fetus, but benefits may outweigh risks of drug) with the highest risk in the second and third trimesters, Dr. Tyler said. “If for some reason you have a patient who’s on tetracycline, stop before she’s in her second trimester.”
She recommended avoiding the antibiotic erythromycin because of studies hinting at risks when used early in pregnancy. Spironolactone is theoretically risky after the week 8 of pregnancy, she said. “Because of the animal studies, we typically do not use this during pregnancy.”
Psoriasis often improves during pregnancy
Psoriasis improves during pregnancy in about half of women with psoriasis and worsens in about 20%, Dr. Tyler said. During pregnancy, topical treatments are the first-line treatment, said Dr. Tyler, who recommends that treatment should begin with topical steroids, then calcipotriene or tacrolimus if needed (J Am Acad Dermatol. 2013 Apr;68[4]:663-71). Cyclosporine is an option, as is phototherapy, she said. In an interview, she noted that phototherapy (narrowband UVB) would be considered next-line therapy in patients who are past the first 28 days of gestation and have failed topical therapy, given they are taking adequate folic acid supplementation, which is present in prenatal vitamins.
“As for biologics, you have to go with older ones that have more data. When we look at newer medications, we don’t know a lot about them,” she said during the presentation.
It’s okay to prescribe oral steroids and antihistamines
Oral steroids are safe during pregnancy, Dr. Tyler said, but “just be judicious” with moderate doses and short durations.
Antihistamines are also appropriate, she said, but be aware of the potential for neonatal sedation during lactation.
As for antibiotics for bacterial infections, azithromycin, penicillins, and cephalosporins are all category B (no risk to human fetus despite possible animal risk; or no risk in animal studies and human studies not done), as are all topical antibiotics except dapsone, which is category C because of a theoretical risk of neonatal hyperbilirubinemia if used near the time of delivery.
Hydroxychloroquine may be appropriate for connective tissue disease, she said, although steroids may be a better option in some cases.
And topical antifungals are considered safer for fungal diseases than systemic medications. She said she prefers clotrimazole and oxiconazole, both category B.
Finally, Dr. Tyler recommended permethrin (category B) for parasitic infections since it has been used extensively in pregnancy without a sign of risk and is the preferred treatment for scabies. It’s a better option than ivermectin, she said.
Postpone surgery until at least the second trimester
If it’s not possible to delay nonemergent dermatologic surgery until after pregnancy, she recommended performing procedures during the second trimester. Destruction of local lesions, however, is safe without anesthesia.
“In summary,” when treating pregnant patients, Dr. Tyler said, “a conservative approach is always best, topical medications are always first-line for any condition, and certain oral medications are safe.”
Dr. Tyler reported no relevant disclosures.
SAN DIEGO – “Some doctors don’t treat them at all, or they undertreat because they’re afraid of prescribing anything,” said dermatologist Kelly H. Tyler, MD.
But the Food and Drug Administration’s new system of prescription drug labeling for pregnant women offers improved insight for dermatologists, and a variety of alternatives are available to commonly used dermatologic drugs that pose risks, said Dr. Tyler, who has a unique perspective on this issue: She used to practice as an ob.gyn.
In her presentation, she provided the following tips when caring for pregnant patients.
Check the prescription drug labeling for pregnant and lactating women
Prior to 2015, the FDA used a letter ratings to denote the risk of medications during pregnancy. The ratings – A, B, C, D, and X – go from “A” showing no fetal risk in controlled studies to “X” in which a drug is contraindicated because “there is no reason to risk use of drug in pregnancy.”
This rating system is problematic, Dr. Tyler said, since it’s imprecise. She noted that about two-thirds of medications have a risk rating of C, which means “Risk cannot be ruled out; human studies may or may not show risk; potential benefits may justify potential risk.” But, she asked, “How are you supposed to know what to do with that kind of information?”
By June 30, 2015, FDA had retired the letter classifications and replaced this system with the Pregnancy and Lactation Labeling final rule, which requires that labels include a pregnancy section with information on pregnancy exposure registries, in addition to risk summaries, clinical considerations, and available data. There are also sections on lactation, including nursing mothers, and females and males of reproductive potential. (This information appears in the prescription drug labeling sections 8.1-8.3.) Labels for medications approved prior to June 30, 2001 did not need to be updated. Labels for newer medications are required to comply within 3-5 years of the 2015 policy change.
Ask female patients about sexual activity
It’s important to ask all premenopausal female patients whether they’re sexually active and whether they are using birth control, trying to conceive, or are currently pregnant. If they’re pregnant, what trimester are they in?
Keep in mind, she said, that women can be pregnant for quite some time without knowing it. Home pregnancy tests may not show positive results for up to 5 weeks after conception, she said. But the embryonic/organogenesis stage – from 2 to 8 weeks – is the most important period for a pregnant mother avoid drugs that could damage the unborn child and is “when you want to avoid most medications,” she said.
Risks don’t end after a few months, however. Dr. Tyler urged dermatologists to keep in mind that the brain, teeth, and bones remain susceptible to damage from teratogenic medications after the eighth week.
Keep topical medications in mind
When it comes to pregnant women, “for most dermatologic therapies, topical medications will be your No. 1 choice” because of less absorption, Dr. Tyler said.
But there are exceptions, she noted. In acne and rosacea, for example, there’s controversy about the safety of topical retinoids. “I would just urge you to not use those medications in pregnancy because you don’t really need to use them,” Dr. Tyler said. “You have other options that are safer.”
Adapalene and tretinoin are listed as category C (risk cannot be ruled out in pregnancy) and topical tazarotene is category X (contraindicated in pregnancy) because of retinoid-like anomalies in animal studies, she said.
Avoid 3 major contraindicated systemic drugs
Isotretinoin, acitretin, and methotrexate are “absolutely contraindicated” for anyone who is pregnant or could become pregnant, Dr. Tyler said.
Use some systemic drugs with caution
Tetracyclines are category D (positive evidence of risk to human fetus, but benefits may outweigh risks of drug) with the highest risk in the second and third trimesters, Dr. Tyler said. “If for some reason you have a patient who’s on tetracycline, stop before she’s in her second trimester.”
She recommended avoiding the antibiotic erythromycin because of studies hinting at risks when used early in pregnancy. Spironolactone is theoretically risky after the week 8 of pregnancy, she said. “Because of the animal studies, we typically do not use this during pregnancy.”
Psoriasis often improves during pregnancy
Psoriasis improves during pregnancy in about half of women with psoriasis and worsens in about 20%, Dr. Tyler said. During pregnancy, topical treatments are the first-line treatment, said Dr. Tyler, who recommends that treatment should begin with topical steroids, then calcipotriene or tacrolimus if needed (J Am Acad Dermatol. 2013 Apr;68[4]:663-71). Cyclosporine is an option, as is phototherapy, she said. In an interview, she noted that phototherapy (narrowband UVB) would be considered next-line therapy in patients who are past the first 28 days of gestation and have failed topical therapy, given they are taking adequate folic acid supplementation, which is present in prenatal vitamins.
“As for biologics, you have to go with older ones that have more data. When we look at newer medications, we don’t know a lot about them,” she said during the presentation.
It’s okay to prescribe oral steroids and antihistamines
Oral steroids are safe during pregnancy, Dr. Tyler said, but “just be judicious” with moderate doses and short durations.
Antihistamines are also appropriate, she said, but be aware of the potential for neonatal sedation during lactation.
As for antibiotics for bacterial infections, azithromycin, penicillins, and cephalosporins are all category B (no risk to human fetus despite possible animal risk; or no risk in animal studies and human studies not done), as are all topical antibiotics except dapsone, which is category C because of a theoretical risk of neonatal hyperbilirubinemia if used near the time of delivery.
Hydroxychloroquine may be appropriate for connective tissue disease, she said, although steroids may be a better option in some cases.
And topical antifungals are considered safer for fungal diseases than systemic medications. She said she prefers clotrimazole and oxiconazole, both category B.
Finally, Dr. Tyler recommended permethrin (category B) for parasitic infections since it has been used extensively in pregnancy without a sign of risk and is the preferred treatment for scabies. It’s a better option than ivermectin, she said.
Postpone surgery until at least the second trimester
If it’s not possible to delay nonemergent dermatologic surgery until after pregnancy, she recommended performing procedures during the second trimester. Destruction of local lesions, however, is safe without anesthesia.
“In summary,” when treating pregnant patients, Dr. Tyler said, “a conservative approach is always best, topical medications are always first-line for any condition, and certain oral medications are safe.”
Dr. Tyler reported no relevant disclosures.
EXPERT ANALYSIS FROM AAD 18