Roche's Accutane labeling
Revised labeling includes bold-faced box containdication for women who are pregnant, recommending a pregnancy test within two weeks prior to therapy. Roche highlighted the revisions in recent letters to MDs and pharmacists. Labeling also includes boxed bold warning statement of Accutane's association with pseudotumor cerebri and additional information on corneal opacities and inflammatory bowel disease. The new labeling, published in March, incorporates recommendations of FDA's Dermatology Advisory Cmte. ("The Pink Sheet" Oct. 24, T&G-6). Roche said additional 20 mg dose will be available "on or about June".
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