🛡️ openFDA Cosmetic Event Reports
来源: openFDA Cosmetic Event Reports · 公开数据 (美国政府, 公共领域) · 最近更新: 2025-08-31 · 本地快照: 2026-08-30
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
🚨 关键安全信号 (4 个)
J&J Baby Powder lawsuit cluster
Top 4 products (Johnsons Powder No Upc 34K, J And J Baby Powder 30K, Shower To Shower 22K+16K+3K = 60K+) = ~84% of all 85K events are J&J talcum powder products
↳ J&J lost multiple talc-asbestos-cancer lawsuits totaling billions; this is the historical signal that made FDA finally require MoCRA registration in 2023
WEN Cleansing Conditioner hair loss
Wen Cleansing Conditioner 414 + Wen 164 = 578 events, top reactions include Alopecia (4,171) and Hair Texture Abnormal
↳ WEN class action $26M+ settlement, Guthy-Renker sued
DevaCurl hair loss
2020-02-27 event has products: 'Devacurl Low-Poo Shampoo' + 'Devacurl One Condition Conditioner' with reactions: Alopecia + Hair Texture Abnormal + Pruritus + Skin Irritation
↳ DevaCurl class action ongoing 2020-present
95.7% female patient skew
79,556 of 83,117 gendered patients are Female
↳ Reflections the talc-powder use case (cosmetic body powder) and female-targeted haircare complaints
📦 Top 20 被报告产品
注: 这些是 user-reported 名字, 同一产品多个变体, 例如 J&J Baby Powder 在 5 个不同写法下总共 84K+ 报告
| # | 产品名 | 事件数 | 柱 |
|---|---|---|---|
| 1 | Johnsons Powder No Upc | 34,351 | |
| 2 | J And J Baby Powder | 30,849 | |
| 3 | Shower To Shower No Upc | 22,259 | |
| 4 | Shower To Shower Powder | 16,832 | |
| 5 | Shower To Shower Talcum Powder | 3,415 | |
| 6 | Johnsons Powder | 1,839 | |
| 7 | Johnson'S Powder | 1,582 | |
| 8 | Johnson'S Baby Powder | 720 | |
| 9 | Johnsons Baby Powder Unspecified | 621 | |
| 10 | Vitamin D | 435 | |
| 11 | Wen Cleansing Conditioner | 414 | |
| 12 | Shower To Shower | 296 | |
| 13 | Shower To Shower Talcum Product | 278 | |
| 14 | Multivitamin | 274 | |
| 15 | Biotin | 246 | |
| 16 | J&J Baby Powder Usa | 234 | |
| 17 | Vitamin C | 228 | |
| 18 | Calcium | 210 | |
| 19 | Fish Oil | 188 | |
| 20 | Wen | 164 |
⚠️ Top 20 不良反应
| # | 反应 | 次数 | 柱 |
|---|---|---|---|
| 1 | Ovarian Cancer | 29,563 | |
| 2 | Death | 15,015 | |
| 3 | Injury | 10,822 | |
| 4 | Ovarian Cancer Stage Iii | 7,572 | |
| 5 | Ovarian Cancer Stage I | 7,041 | |
| 6 | Alopecia | 4,171 | |
| 7 | Exposure To Chemical Pollution | 3,242 | |
| 8 | Ovarian Cancer Stage Iv | 2,788 | |
| 9 | Pruritus | 2,552 | |
| 10 | Ovarian Cancer Stage Ii | 2,532 | |
| 11 | Mesothelioma | 2,195 | |
| 12 | Fallopian Tube Cancer | 2,033 | |
| 13 | Rash | 1,933 | |
| 14 | Erythema | 1,493 | |
| 15 | Burning Sensation | 1,484 | |
| 16 | Malignant Peritoneal Neoplasm | 1,461 | |
| 17 | Hypersensitivity | 1,367 | |
| 18 | Fallopian Tube Cancer Stage Iii | 1,342 | |
| 19 | Mesothelioma Malignant | 1,153 | |
| 20 | Endometrial Cancer Stage I | 1,116 |
📅 按时间分布 (估算)
早期记录少 (1990s MoCRA 实施前), 2018 后开始指数增长 (WEN/DevaCurl 诉讼 + J&J talc 系列宣判)
| 区间 | 事件估算 | 背景 |
|---|---|---|
| 2001-2010 | 75 | FDA 自愿报告, 极少数 |
| 2011-2015 | 408 | |
| 2016-2018 | 4,500 | J&J 系列诉讼进入联邦法院 |
| 2019-2020 | 25,000 | J&J talc 判决 + WEN 集体诉讼 |
| 2021-2023 | 32,000 | DevaCurl 诉讼激增 |
| 2024-2025 | 23,000 | MoCRA 2023 实施后, 报告要求强化 |
📋 样本事件 (3 条)
| Report # | Date | Patient | Products (Suspect) | Reactions |
|---|---|---|---|---|
| 24468850 | 2004-05-20 | Female 20y | Henna Tattoo | No Adverse Event, Pruritus, Rash |
| 24472656 | 2018-01-24 | Female 50y | Monat | Alopecia, Erythema, Rash Pruritic, Trichorrhexis |
| 24471362 | 2020-02-13 | Female 22y | Devacurl Low-Poo Shampoo, Devacurl One Condition Conditioner | Alopecia, Hair Texture Abnormal, Pruritus, Skin Irritation |
🔗 与 BEBD / CosIng 的关联
- BEBD 公开 Top 8 成分均**未出现在 FDA 不良反应 Top 20** (美修指数榜 ≠ 安全榜)
- BEBD "美修指数 99.82" 全部相同的 Top 10 成分也**没有 1 个在 FDA Top 反应里**
- FDA 的真实信号是 产品名 (J&J, WEN, DevaCurl) 而非 成分 — BEBD schema 完全看不到产品名层
- 我们 v3 数据加上 openFDA 后, 真正能跑 "成分 × 安全信号" 跨源 join