Eflornithine

The Basics

What is Eflornithine?

Used to slow the growth of unwanted hair, usually around the lips or under the chin.

Brand names for Eflornithine

Vaniqa

How Eflornithine is classified

Antiparasitic Agents, Antiprotozoal Agents, Enzyme Inhibitors, Trypanocidal Agents

Eflornithine During Pregnancy

Eflornithine pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Eflornithine while pregnant

In the first dermal embryo-fetal development study in rats treated with eflornithine hydrochloride cream, 13.9% (in which no precautions were taken to prevent ingestion of drug from application sites), maternal toxicity and fetal effects including reduced numbers of live fetuses, decreased fetal weights, and delayed ossification and development of the viscera were observed at doses of 225 and 450 mg/kg (15X and 29X the MRHD based on BSA, respectively). When the study was repeated under conditions that avoided ingestion from application sites, no maternal, fetal or teratogenic effects were observed at doses up to 450 mg/kg (29X the MRHD based on BSA). In the first study in which no precautions were taken to prevent ingestion, circulating plasma levels were 11- to 14-fold higher than in the second study in which ingestion was prevented. In a dermal embryo-fetal development study in rabbits treated with VANIQA¬Æ (eflornithine hydrochloride) cream, 13.9% no adverse maternal or fetal effects occurred at doses up to 90 mg/kg (11X the MRHD based on BSA). Significant dermal irritation, as well as possible ingestion of VANIQA¬Æ occurred at 300 mg/kg/day (36X the MRHD based on BSA) and was associated with maternal deaths, abortions, increased fetal resorptions, and reduced fetal weights. Fetotoxicity in the absence of maternal toxicity has been reported in oral studies with eflornithine with fetal no-effect doses of 80 mg/kg in rats and 45 mg/kg in rabbits. In these studies, no evidence of teratogenicity was observed in rats given up to 200 mg/kg or in rabbits given up to 135 mg/kg. Although VANIQA¬Æ was not formally studied in pregnant patients, 22 pregnancies occurred during the trials. Nineteen of these pregnancies occurred while patients were using VANIQA¬Æ. Of the 19 pregnancies, there were 9 healthy infants, 4 spontaneous abortions, 5 induced/elective abortions, and 1 birth defect (Down’s Syndrome to a 35-year-old). Because there are no adequate and well-controlled studies in pregnant women, the risk/benefit ratio of using VANIQA¬Æ in women with unwanted facial hair who are pregnant should be weighed carefully with serious consideration for either not implementing or discontinuing use of VANIQA¬Æ

Taking Eflornithine While Breastfeeding

What are recommendations for lactation if you're taking Eflornithine?

Limited information indicates that maternal intravenous eflornithine 400 mg/kg daily for 7 days does not cause any adverse serious effects in breastfed infants. Eflornithine is poorly absorbed after topical application, so it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants.

Maternal / infant drug levels

Limited information indicates that maternal intravenous eflornithine 400 mg/kg daily for 7 days does not cause any adverse serious effects in breastfed infants. Eflornithine is poorly absorbed after topical application, so it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants.

Possible effects of Eflornithine on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Eflornithine

None listed