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Effect of Dermatologic Drugs on Pregnancy and Lactation



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Am Fam Physician. 1998 Feb 1;57(3):544-546.

Physicians are often reluctant to prescribe dermatologic drugs to pregnant and lactating women, since this type of treatment is often considered elective rather than life-saving. Despite opinions and advisories disseminated by various organizations, scientists and manufacturers, no one database provides definitive guidelines on the exact risks associated with drug use during pregnancy and lactation. Data from birth defect registries are inconclusive as a result of the small numbers of reported cases, the low frequencies of exposure to certain drugs and the concern that findings may not be extrapolated to all populations. Reed evaluated dermatologic drugs with a low known risk in pregnant and lactating women.

More than 30 years ago, the U.S. Food and Drug Administration (FDA) devised regulations for drug use during pregnancy. These regulations became known as the Pregnancy and Lactation Categories. These categories are graded, balancing fetal risk against potential benefits to the mother. Drugs in FDA categories A and B pose either no risk or minimal risk, respectively. Category C drugs are those in which risk to humans cannot be ruled out. Topical nystatin was the only category A drug found. Since category B drugs are not without risk, informed consent should be obtained before prescribing these drugs during pregnancy. Another source of information, the Teratogen Information Service (TERIS), rates drugs according to exposure risk to the fetus or infant (none, minimal, moderate and high).

Patients who need or desire elective treatment of dermatologic problems during pregnancy often use topical agents. Most benign topical agents are FDA category B drugs. The accompanying table on topical drugs with minimal risk shows only those category B drugs not contraindicated by the manufacturer for use during pregnancy. Some topical agents, such as erythromycin and benzoyl peroxide, are designated as category C drugs. Use of small amounts of topical steroids during pregnancy is not believed to be associated with significant risk to the fetus.

Topical Drugs with Minimal Risk During Pregnancy

Topical drug FDA pregnancy category Drug class

Amphotericin B

B

Antifungal

Azelaic acid

B

Antiacne

Bacitracin

OTC

Antibiotic

Benzoyl peroxide

C, OTC

Antiacne

Cicloprox

B

Antifungal

Clindamycin

B

Antibiotic

Erythromycin

B, C

Antibiotic, antiacne

Haloprogin

B

Antifungal

Hydroquinone agent

B

Bleaching

Masoprocol

B

Antiproliferative

Meclocycline

B

Antiacne

Metronidazole gel or cream

B

Antiacne

Mupirocin

B

Antibiotic

Naftifine hydrochloride

B

Antifungal

Nystatin

A

Antifungal*

Oxiconazole nitrate

B

Antifungal

Permethrin

B

Antiscabetic

Terbinafine

B

Antifungal


FDA = U.S. Food and Drug Administration; OTC = over the counter.

*—Topical administration of intravaginal yeast medications is not advised close to term because there is a risk of contamination if membranes have ruptured.

Reprinted with permission from Reed BR. Dermatologic drugs, pregnancy, and lactation. A conservative guide. Arch Dermatol 1997;133:894–8.

Topical Drugs with Minimal Risk During Pregnancy

View Table

Topical Drugs with Minimal Risk During Pregnancy

Topical drug FDA pregnancy category Drug class

Amphotericin B

B

Antifungal

Azelaic acid

B

Antiacne

Bacitracin

OTC

Antibiotic

Benzoyl peroxide

C, OTC

Antiacne

Cicloprox

B

Antifungal

Clindamycin

B

Antibiotic

Erythromycin

B, C

Antibiotic, antiacne

Haloprogin

B

Antifungal

Hydroquinone agent

B

Bleaching

Masoprocol

B

Antiproliferative

Meclocycline

B

Antiacne

Metronidazole gel or cream

B

Antiacne

Mupirocin

B

Antibiotic

Naftifine hydrochloride

B

Antifungal

Nystatin

A

Antifungal*

Oxiconazole nitrate

B

Antifungal

Permethrin

B

Antiscabetic

Terbinafine

B

Antifungal


FDA = U.S. Food and Drug Administration; OTC = over the counter.

*—Topical administration of intravaginal yeast medications is not advised close to term because there is a risk of contamination if membranes have ruptured.

Reprinted with permission from Reed BR. Dermatologic drugs, pregnancy, and lactation. A conservative guide. Arch Dermatol 1997;133:894–8.

Life-threatening dermatologic conditions may require the use of systemic antibiotics during pregnancy. The accompanying table on drugs that may be used when medically necessary (p. 546) lists the FDA and TERIS risk categories of these drugs. Most of these drugs are either category B or C, but much of the data regarding risk have been compiled from less than optimal sources. Ibuprofen, ketoprofen and naproxen are category B drugs that should not be used during the latter part of pregnancy. The use of lidocaine with or without epinephrine for routine dermatologic excisions during pregnancy has not been contraindicated. TERIS ratings indicate that oral corticosteroids are unlikely to cause harm, but the data sources are listed as fair to poor.

Systemic Antibiotics, Antiviral Agents, Antihistamines and Antifungal Agents for Use When Medically Necessary During Pregnancy

Drug FDA pregnancy category TERIS category
Risk Data

Antibiotics

Amoxicillin

B

None

Good

Azithromycin

B

N/A

N/A

Cephalosporins

B

None/minimal

Poor/fair

Dicloxacillin

B

None/minimal

Poor/fair

Erythromycin

B*

None

Fair/good

Penicillin

B

None

Good

Antiviral agents

Acyclovir

C

Unlikely

Fair/good

Famciclovir

B

N/A

N/A

Valacyclovir

B

N/A

N/A

Antihistamines

Brompheniramine maleate

B

None

Fair

Chlorpheniramine

B

None/minimal

Fair/good

Cyproheptadine hydrochloride

B

Undetermined

Poor

Diphenhydramine

B

None/minimal

Fair/good

Antifungal agent

Nystatin

B

None

Fair/good


FDA = U.S. Food and Drug Administration; TERIS = Teratogen Information Service; N/A = not available.

*—Except estolates and clarithromycin.

Reprinted with permission from Reed BR. Dermatologic drugs, pregnancy, and lactation. A conservative guide. Arch Dermatol 1997;133:894–8.

Systemic Antibiotics, Antiviral Agents, Antihistamines and Antifungal Agents for Use When Medically Necessary During Pregnancy

View Table

Systemic Antibiotics, Antiviral Agents, Antihistamines and Antifungal Agents for Use When Medically Necessary During Pregnancy

Drug FDA pregnancy category TERIS category
Risk Data

Antibiotics

Amoxicillin

B

None

Good

Azithromycin

B

N/A

N/A

Cephalosporins

B

None/minimal

Poor/fair

Dicloxacillin

B

None/minimal

Poor/fair

Erythromycin

B*

None

Fair/good

Penicillin

B

None

Good

Antiviral agents

Acyclovir

C

Unlikely

Fair/good

Famciclovir

B

N/A

N/A

Valacyclovir

B

N/A

N/A

Antihistamines

Brompheniramine maleate

B

None

Fair

Chlorpheniramine

B

None/minimal

Fair/good

Cyproheptadine hydrochloride

B

Undetermined

Poor

Diphenhydramine

B

None/minimal

Fair/good

Antifungal agent

Nystatin

B

None

Fair/good


FDA = U.S. Food and Drug Administration; TERIS = Teratogen Information Service; N/A = not available.

*—Except estolates and clarithromycin.

Reprinted with permission from Reed BR. Dermatologic drugs, pregnancy, and lactation. A conservative guide. Arch Dermatol 1997;133:894–8.

Few topical or systemic dermatologic drugs are contraindicated during lactation, although some, including topical antifungal agents, have manufacturer's prohibitions. Drugs with no specific contraindications during lactation are also listed. The American Academy of Pediatrics regards prednisolone and prednisone as usually compatible with lactation.

The author presents a list of dermatologic drugs that may be used during pregnancy and lactation. Potential problems can be minimized by increasing awareness of potential fetal risks and obtaining informed consent from patients. Safety must always be weighed against the need to use the specific drug for a documented condition.

Reed BR. Dermatologic drugs, pregnancy, and lactation. A conservative guide. Arch Dermatol. 1997;133:894–8.


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