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The iPLEDGE Program was instituted as a replacement for the failed SMART program (System to Manage Accutane Related Teratogenicity). [14] Instituted in April 2002, SMART aimed to eliminate isotretinoin-induced birth defects by preventing exposure to the drug during pregnancy.
Since the 1980s, the FDA has tried to address isotretinoin’s risks, eventually landing on the iPledge program, a risk evaluation and mitigation strategy (REMS) whose goal is to ensure the ...
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 ...