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The iPLEDGE program was put into place a group formed by the companies that manufactured the drug at the time called the Isotretinoin Products Manufacturing Group (IPMG) under the direction of the Food and Drug Administration. The program launched on March 1, 2006, at the beginning of the annual meeting of the American Academy of Dermatology.
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]
IPLEDGE program; Isotretinoin This page was last edited on 5 September 2022, at 01:20 (UTC). Text is available under the Creative Commons Attribution ...
Isotretinoin (formerly Accutane) helps control sebum production to reduce breakouts. Some people who take it may notice signs of hair thinning, a lack of new hair growth or more hair fallout than ...
The name isotretinoin is the same root tretinoin plus the prefix iso-. Regarding pronunciation, the following variants apply equally to both tretinoin and isotretinoin. Given that retinoic is pronounced / ˌ r ɛ t ɪ ˈ n oʊ ɪ k /, [43] [44] [42] [45] it is natural that / ˌ t r ɛ t ɪ ˈ n oʊ ɪ n / is a commonly heard pronunciation.
[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]
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 isotretinoin, which causes serious birth defects; clozapine, which can cause agranulocytosis; and thalidomide, which is used to treat leprosy and certain cancers but causes serious birth defects. [4]
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