Tretinoin Pregnancy and Breastfeeding Warnings

Tretinoin is also known as: Vesanoid

Tretinoin Pregnancy Warnings

Tretinoin has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and teratogenicity. The drug has been reported to cause fetal resorptions and a decrease in live fetuses in all animals studied. There are no controlled data in human pregnancy. Tretinoin should only be given during pregnancy when there are no alternatives and benefit outweighs risk. It is extremely important that all females use effective contraception both during tretinoin therapy and for one month following the discontinuation of therapy. Contraception is considered to be mandatory by the manufacturer even when there is a history of infertility or menopause, unless the woman has had a hysterectomy. When contraception is required, two reliable forms of contraception should be used simultaneously (unless abstinence is the chosen method).

One week before beginning tretinoin therapy, the patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 milli-intl units/L. Monthly pregnancy testing and contraception counseling are recommended throughout treatment. Increased spontaneous abortions and major human fetal abnormalities related to the use of other retinoids have been reported. Reported defects have included abnormalities of the CNS, musculoskeletal system, external ear, eye, thymus and great vessels, facial dysmorphia, cleft palate, and parathyroid hormone deficiency. Some of these abnormalities ended up in fatalities.

Tretinoin Breastfeeding Warnings

There are no data on the excretion of tretinoin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, mothers should discontinue nursing prior to taking this drug.

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