FDA revises warnings on 3 estradiol patches

Cardiovascular, breast cancer, and dementia statements are removed, but other risk information remains.

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The FDA revised boxed warnings for Minivelle, Vivelle, and Vivelle-Dot, removing statements about cardiovascular disease, breast cancer, and probable dementia.
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Information about cardiovascular and breast cancer risks remains elsewhere in the prescribing information, and the boxed warning for endometrial cancer with unopposed systemic estrogen remains.
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The revised Vivelle-Dot label retains contraindications for current or prior breast cancer, deep vein thrombosis, pulmonary embolism, and arterial thromboembolic disease.
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The label advises considering therapy initiation in women younger than 60 years or within 10 years of menopause and notes uncertainty about applying WHI findings to other estrogen products or routes.
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The FDA reported that estradiol patch output doubled over 12 months and that no nationwide shortage was imminent, although localized supply difficulties persisted.

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