Active Ingredient: Isotretinoin
Some people develop contact lens intolerance as a result.
John's Wort, phenytoin, and systemic corticosteroids. Isotretinoin is primarily 99.
Isotretinoin also oxidizes, irreversibly, to 4-oxo-isotretinoin—which forms its geometric isomer 4-oxo-tretinoin. Experiments completed in 1971 showed that the compound was likely to be ineffective for cancer and, surprisingly, that it could be useful to treat acne.
However, they also showed that the compound was likely to cause birth defects, so in light of the events around thalidomide, Roche abandoned the product.
In 1975, Gary Peck and Frank Yoder independently rediscovered the drug's use as a treatment of cystic acne while studying it as a treatment for lamellar ichthyosis, and published that work.
Roche resumed work on the drug. In clinical trials, subjects were carefully screened to avoid including women who were or might become pregnant.
Roche's New Drug Application for isotretinoin for the treatment of acne included data showing that the drug caused birth defects in rabbits. The FDA approved the application in 1982.
Scientists involved in the clinical trials published articles warning of birth defects at the same time the drug was launched in the US, but nonetheless isotretinoin was taken up quickly and widely, both among dermatologists and general practitioners.
Cases of birth defects showed up in the first year, leading the FDA to begin publishing case reports and to Roche sending warning letters to doctors and placing warning stickers on drug bottles, and including stronger warnings on the label.
Lawsuits against Roche started to be filed. In 1983 the FDA's advisory committee was convened and recommended stronger measures, which the FDA took and were that time unprecedented: warning blood banks not to accept blood from people taking the drug, and adding a warning to the label advising women to start taking contraceptives a month before starting the drug.
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Low-dose schema of isotretinoin in acne vulgaris. Int J Clin Pharmacol Res. Medium dose isotretinoin for the treatment of acne.
Disease of the sebaceous glands. Dermatology in General Medicine. New York: McGraw-Hill; 1999.