US Food and Drug Administration Reports of Pregnancy and Pregnancy-Related Adverse Events Associated With Isotretinoin | Zendy

Elizabeth Tkachenko | Zendy; Sean Singer | Zendy; Priyank Sharma | Zendy; John S. Barbieri | Zendy; Arash Mostaghimi | Zendy

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US Food and Drug Administration Reports of Pregnancy and Pregnancy-Related Adverse Events Associated With Isotretinoin

Author(s) -

Elizabeth Tkachenko,

Sean Singer,

Priyank Sharma,

John S. Barbieri,

Arash Mostaghimi

Publication year - 2019

Publication title -

jama dermatology

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.128

H-Index - 166

eISSN - 2168-6084

pISSN - 2168-6068

DOI - 10.1001/jamadermatol.2019.1388

Subject(s) - isotretinoin , medicine , pregnancy , adverse effect , obstetrics , adverse event reporting system , acne , gynecology , dermatology , genetics , biology

iPLEDGE is a rigorous program initiated in 2006 to reduce fetal exposure to isotretinoin, a disease-modifying medication for acne that carries a risk of teratogenesis. Despite the imposition of iPLEDGE requirements on patients and clinicians, the scope of isotretinoin-related adverse events is unknown.

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