Isotretinoin Pregnancy and Breast Feeding Warnings
Isotretinoin is also known as: Accutane, Amnesteem, Claravis, Sotret
Overview
Do not become pregnant. Isotretinoin can cause serious birth defects, miscarriage, early birth, or death of the fetus. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using Isotretinoin and call your health care provider. Do not breast-feed while taking Isotretinoin and for 1 month after stopping Isotretinoin . Isotretinoin may pass through your milk and harm the baby.
Isotretinoin Pregnancy Warnings
Isotretinoin has been assigned to pregnancy category X by the FDA. Isotretinoin is known to be teratogenic and its use is contraindicated during pregnancy or in anyone planning on becoming pregnant. When used during pregnancy, isotretinoin causes central nervous system, skull, external ear, eye, and cardiovascular abnormalities, as well as facial dysmorphia, thymus gland abnormalities, and parathyroid hormone deficiencies.
In an FDA Public Health Advisory, the FDA announced the approval of the Strengthened Risk Management Program for Isotretinoin to reduce the risk of exposure during pregnancy. The new program is called iPLEDGE. Beginning December 31, 2005, all prescribers and patients must be registered in iPLEDGE in order to prescribe or receive isotretinoin. This registration process ensures that prescribers and patients agree to assume specific responsibilities to ensure that patients do not become pregnant while taking isotretinoin and do not get prescribed the medicine if they are pregnant. For further details on iPLEDGE go to: http://www.fda.gov/cder/drug/infopage/accutane/default.htm. Isotretinoin was first marketed in the US in September of 1982. In July of 1983, the first reports of malformed infants were received by the manufacturer prompting a "Dear Doctor" letter reiterating the dangers of isotretinoin use in pregnancy. Despite further educational efforts by the manufacturer, unintentional exposures of pregnant women to isotretinoin continue to occur. Cardiovascular abnormalities observed include interrupted aortic arch, ventricular septal defect, atrial septal defect, transposition of the great vessels, and Tetralogy of Fallot. Ear abnormalities include low-set, micropinnae or absent ears. Central nervous system abnormalities include cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, and cranial nerve deficit. Craniofacial abnormalities frequently include occipital vaulting, and/or a sharply sloping, narrow forehead, wide-spaced eyes, small chin, and flat, depressed nasal bridge. Dai et al. 1992 reported 433 first-trimester exposures to isotretinoin of which pregnancy outcomes was known in 409 cases. Elective abortion was performed in 222 (54%) of these pregnancies and 29 (7%) ended in spontaneous abortions. Of 151 births, 72 (48%) were normal and 71 (47%) had congenital malformations. Malformations and spontaneous abortions occurred in women whose exposure to isotretinoin had been less than one week. Limb reduction defects have been reported in at least two infants, along with other multiple malformations characteristic to isotretinoin exposure. One infant with isotretinoin embryopathy, including thymic hypoplasia, demonstrated progressive attrition of T cells following her birth. She died after several bouts with pneumonia. It is suggested that isotretinoin may provide insult to the immune system as well as other teratogenic effects. Another infant with isotretinoin embryopathy and bilateral major ear deformities also demonstrated significant bilateral conductive hearing loss and left sided sensorineural loss. Peripheral and central vestibular dysfunction was also present.
Isotretinoin Lactation Warnings
There are no data on the excretion of isotretinoin into human milk. Because of the potential for adverse effects in nursing infants, breast-feeding is considered contraindicated by the manufacturer.
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