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Acitretin Pregnancy and Breastfeeding Warnings

Acitretin is also known as: Soriatane, Soriatane CK

Acitretin Pregnancy Warnings

Severe birth defects have been reported when conception occurred during and after completion of treatment with acitretin and/or etretinate. The events reported have not been consistently correlated with retinoid-induced embryopathy. Major human fetal abnormalities associated with acitretin have been reported including menigomyelocele, menigoencephalocele, multiple sclerosis, facial dysmorphia, syndactyly, absence of terminal phalanges, malformations of hip, ankle, and forearm, low-set ears, high palate, decreased cranial volume, cardiovascular malformation, and alterations of the skull and cervical vertebrae. 318 cases have been prospectively reported involving pregnancies and the use of acitretin, etretinate or both. In 238 cases, conception occurred after the last dose of etretinate (103 cases), acitretin (126 cases), or both (9 cases). In about half of the cases the fetal outcome was unknown; 62 were terminated and 14 were spontaneously aborted. In the remaining 118 cases, fetal outcome was known and 15 of the outcomes had abnormalities including absent hand/wrist, clubfoot, GI malformation, hypocalcemia, hypotonia, limb malformation, neonatal apnea/anemia, neonatal ichthyosis, placental disorder/death, undescended testicle, and 5 cases of premature birth. In the 126 prospective cases where conception occurred after the last dose of acitretin only, 43 occurred at least 1 year but less than 2 years after the last dose. Of the 43 cases, only 3 cases reported abnormalities including limb and GI tract malformation, and premature birth. Malformations have been reported from 3 of 35 retrospective case reports where conception occurred at least 1 year but less than 2 years after the last dose of etretinate, acitretin, or both. Reported birth defects included heart and congenital malformations, and Turner's Syndrome. 4 cases reported abnormal outcomes when conception occurred at least 2 or more years after the last dose of acitretin which included foot and heart malformations and unspecified neonatal and infancy disorders. In addition, there were 3 cases reported of abnormal outcomes including chromosome disorder, forearm aplasia and stillbirth when conception occurred 2 or more years after the last dose of etretinate. In a detailed case report of a pregnancy exposed to acitretin 10 days after conception and throughout the 1st trimester, a 34-year-old woman was treated with 50 mg/day of acitretin for severe palmoplantar epidermolytic keratoderma for 8 weeks. Pregnancy was diagnosed 6 weeks after therapy was stopped. The pregnancy was terminated after consent by the parents. Postmortem radiography and an autopsy showed severe anomalies of the upper and lower limbs and craniofacial and internal anomalies. However, levels of acitretin and cis-acitretin were undetectable in fetal tissue.

Acitretin has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of embryotoxicity and teratogenicity in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg/kg. There are no controlled data in human pregnancy. However, acitretin is known to be teratogenic to humans. Acitretin use is considered contraindicated during pregnancy.

Acitretin Breastfeeding Warnings

Acitretin has been reported to be excreted into human milk. The effects in the nursing infant are unknown. The manufacturer states that nursing mothers should not receive acitretin.

Acitretin is excreted into the milk of lactating rats and humans. One experiment tested the milk of an 8 month postpartum woman who was treated for extensive plague psoriasis and acral pustulosis with single daily dosages of 40 mg of acitretin. Nursing was stopped when therapy was initiated. Milk was collected daily with an electric pump before the dose and 12 hours after the dose. At steady state, the concentration of acitretin and its main metabolite ranged from 30 to 40 ng/mL (corresponding to a milk:serum ratio of 0.18). The estimated dose a nursing infant would receive is 1.5% of the maternal dose. The American Academy of Pediatrics classifies the drug as compatible with breast-feeding although there is a potential for toxicity.

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