In most other countries, a consent form is required which explains these risks.
Women taking isotretinoin must not get pregnant during and for 1 month after the discontinuation of isotretinoin therapy.
It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis.
It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Isotretinoin is primarily used as a treatment for severe acne.
In the United States, since March 2006 the dispensing of isotretinoin is run through a website called i PLEDGE.
Isotretinoin may represent an efficacious and safe alternative systemic form of therapy for recalcitrant condylomata acuminata (RCA) of the cervix.In most countries this therapy is currently unapproved and only used if other therapies failed.Isotretinoin is a teratogen; there is about a 20–35% risk for congenital defects in infants exposed to the drug in utero, and about 30–60% of children exposed to isotretinoin prenatally have been reported to show neurocognitive impairment.Women with child-bearing potential must commit to using two forms of effective contraception simultaneously for the duration of isotretinoin therapy and for a month immediately preceding and a month immediately following therapy.Additionally they must have two negative pregnancy tests 30 days apart and have negative pregnancy tests before each prescription is written.
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Isotretinoin, also known as 13-cis-retinoic acid (and colloquially referred to by its former brand name Accutane or Roaccutane), is a medication primarily used to treat severe acne.