The history, development and current status of isotretinoin: a review article.

Isotretinoin, a potent retinoid, is highly effective in the treatment of severe acne vulgaris. Its nearly 60-year history began with the Swiss pharmaceutical company La Roche in the 1960s, where it was initially studied for potential benefits in cancer treatment. This article delineates the historical trajectory of isotretinoin from early clinical trials in the 1970s and 1980s, highlighting its efficacy and safety profile, leading to US Food and Drug Administration approval in 1982. The review also addresses contemporary concerns such as the drug's teratogenicity and potential link to depression and provides an overview of regulatory measures and mixed research findings on mental health and sexual dysfunction. The current status of isotretinoin in other medical areas, including its exploration as a chemotherapy adjunct, is examined.