Isotretinoin (13-cis-retinoic acid, marketed as Accutane) is a drug used for treating severe acne. It can be highly teratogenic when taken during pregnancy. Women of child bearing age taking this drug need to take extreme care to not become pregnant.


Time of exposure resulting in malformations: any time after the 15th day following conception


Organs affected by malformations:

(1) craniofacial

(2) cardiac

(3) central nervous system

(4) thymic

(5) musculoskeletal


Craniofacial malformations:

(1) microtia and/or anotia (small or absent external ear)

(2) stenosis of the external ear canal

(3) facial nerve paralysis

(4) accessory parietal sutures

(5) micrognathia

(6) depressed nasal bridge

(7) ocular hypertelorism

(8) cleft palate


Cardiac malformations:

(1) hypoplastic left ventricle

(2) interrupted aortic arch

(3) ventricular septal defect

(4) conotruncal malformations (transposition of the great vessels, tetralogy of Fallot, truncus arteriosus)

(5) atrial septal defects


Central nervous system malformations:

(1) hydrocephalus

(2) microcephaly

(3) cerebellar hypoplasia

(4) cerebellar microdysgenesis

(5) mental retardation or behavioral disturbances

(6) spina bifida

(7) optic nerve blindness

(8) retinal defects

(9) microphthalmia


Thymic malformations:

(1) hypoplasia or aplasia

(2) dysplasia

(3) ectopia


Musculoskeletal malformations:

(1) limb hypoplasia

(2) decreased muscle tone


Accutane can also result in stillbirths or spontaneous abortions.


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