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The Food and Drug Administration has granted "pediatric exclusivity" to Accutane (isotretinoin), extending the drug’s patent for 6 months. In order to spur the study of drugs in children and adolescents, a section of the FDA Modernization Act of 1997 created a financial incentive for manufacturers to study their products in children: a 6-month extension on the drug’s patent if they provide acceptable pediatric data on the product.
I was disappointed that "Strategies for Clear Skin" (Beauty in Action, March) neglected to mention that one of the most serious side effects of Accutane, a prescription drug for severe acne, is the possibility of birth defects if a woman becomes pregnant while using the drug.
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I’ve been taking Accutane for many years and although I’ve never had any problems, dermatologists advise their patients to use two forms of birth control, because if a woman does become pregnant, the results can be devastating.
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