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However, there have also been many reports and studies criticizing the negative side effects of isotretinoin have been published over the years. The iPLEDGE Program was instituted as a replacement for the failed SMART program (System to Manage Accutane Related Teratogenicity). [14]
Pre-iPledge, there was the Accutane Pregnancy Prevention Program, which was developed in the late 1980s. It asked much of the same things iPledge does: monthly pregnancy tests, use of ...
Many dermatologists and patients say they haven't been able to get isotretinoin (formerly Accutane) since a mid-December update to the iPledge website. Patients going weeks, months without acne ...
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]
Side effects include increased skin photosensitivity, dryness, redness, and occasional peeling. [95] Sunscreen use is often advised during treatment, to prevent sunburn . Lower concentrations of benzoyl peroxide are just as effective as higher concentrations in treating acne but are associated with fewer side effects.
Accutane Side Effects. Potential side effects of isotretinoin treatment can be aggravating, to say the least. According to the FDA (U.S. Food and Drug Administration), they include:
But in studies meant to test a drug for side effects, placebos have far less import. Besides, INT-41 was designed as a long-term study, and as Caers himself had pointed out, it is difficult ethically and practically to ask children to take no medicine when medicine could help them, let alone ask them to do so for a long time.
A Janssen executive complained that a J&J-funded article about Risperdal contained a “nauseating amount of information” about side effects. The study’s findings would immediately be circulated to the sales teams in the field and be formally published in the highly respected Journal of Child Psychiatry under the title, “Prolactin Levels ...