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The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) intended to manage the risk of birth defects caused by isotretinoin, a prescription medication used for the treatment of acne.
The FDA requires that isotretinoin patients use iPledge as part of a Risk Evaluation and Management Strategy to prevent fetal exposure to the medication. (People who take other medications also ...
Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication used to treat skin diseases like harlequin-type ichthyosis, and lamellar ichthyosis, and severe cystic acne or moderate acne that is unresponsive to antibiotics. [6]
[103] iPledge requires the woman to have two negative pregnancy tests and to use two types of birth control for at least one month before isotretinoin therapy begins and one month afterward. [103] The effectiveness of the iPledge program is controversial due to continued instances of contraception nonadherence. [103] [104]
Low-dose or microdosed Accutane is an off-label use of isotretinoin, or Accutane, by which patients take a lower dose of the medication over a longer period of time. But does it make enough of a ...
Accutane causes the skin on the lips to shed so quickly that it can cause thick, chunky flakes to come off, which can worsen and become red if you pick the skin off, says Goldman. He recommends ...
IPLEDGE program; Isotretinoin This page was last edited on 5 September 2022, at 01:20 (UTC). Text is available under the Creative Commons Attribution ...
The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane, which causes serious birth defects, Clozaril, which can cause agranulocytosis, and Thalidomide, which is used to treat leprosy but causes serious birth defects. [4]