Effect of dermatologic drugs on pregnancy and lactation

Effect of dermatologic drugs on pregnancy and lactation – Tips from Other Journals

Barbara Apgar

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.

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.

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.

Topical Drugs with Minimal Risk

During Pregnancy

FDA pregnancy

Topical Drug 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,


Haloprogin B Antifungal

Hydroquinone B Bleaching


Masoprocol B


Meclocycline B Antiacne

Metronidazole gel B Antiacne

or cream

Mupirocin B Antibiotic

Naftifine B Antifungal


Nystatin A Antifungal(*)

Oxiconazole nitrate B Antifungal

Permethrin B Antiscabetic

Terbinafine B Antifungal

COPYRIGHT 1998 American Academy of Family Physicians

COPYRIGHT 2000 Gale Group