Soriatane Pregnancy Warnings
Animal studies have shown this drug to be embryotoxic and/or teratogenic. There are no controlled data in human pregnancy. Major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; 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. Female patients should not be pregnant when therapy is initiated, they should not become pregnant while taking this drug, and for at least 3 years after therapy termination. Additionally, females of reproductive potential should be advised that they should not consume beverages or products containing ethanol while on therapy and for 2 months after drug has been discontinued. Female patients should be advised that any method of birth control can fail, including tubal ligation, and that microdosed progestin "minipill" preparations are not recommended for use with this drug.
Samples of seminal fluid from male patients treated with this drug have been assayed for the presence of acitretin. The maximum concentration of acitretin observed in the seminal fluid of these men was 12.5 ng/mL. Although it appears that residual acitretin in seminal fluid poses little, if any, risk to a fetus while a male patient is taking the drug or after it is discontinued, the no-effect limit for teratogenicity is unknown and there is no registry for birth defects associated with acitretin.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
This drug is contraindicated in women of reproductive potential.
AU TGA pregnancy category: X
US FDA pregnancy category: X
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