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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.
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]
In 2002, a second risk-management program, the System to Manage Accutane-Related Teratogenicity (SMART), was instituted, introducing a requirement of two negative pregnancy tests before starting ...
After its introduction in the United States, scientists identified isotretinoin as a medication highly likely to cause birth defects if taken during pregnancy. In the United States, more than 2,000 women became pregnant while taking isotretinoin between 1982 and 2003, with most pregnancies ending in abortion or miscarriage .
As of Friday, the iPledge site does have one noticeable new feature: It now allows providers to directly assist some patients having login issues through the site, making it possible for them to ...
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Women should speak to their doctor or healthcare professional before starting or stopping any medications while pregnant. [1] Drugs taken in pregnancy including over-the counter-medications, prescription medications, nutritional supplements, recreational drugs, and illicit drugs may cause harm to the mother or the unborn child.
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk. Every drug has specific information listed in its product literature.