食品药品监管局警告两款止痛产品含未标示处方药成分：RX7 Articulaciones与Ort-Flx经网络销售
美国食品药品监管局（FDA）于10月28日发布两则公众通知，劝消费者不要购买或使用 RX7 Articulaciones 与 Ort-Flx。两款产品分别以缓解关节与肌肉疼痛、疼痛与关节炎为卖点，在包括 eBay 在内的多个网站销售，也可能在部分零售店出售；食品药品监管局实验室检测确认，两款产品都含有未在产品标签上标示的处方药成分。
其中，RX7 Articulaciones 被检出含有双氯芬酸与地塞米松；Ort-Flx 被检出含有双氯芬酸、地塞米松与美索巴莫，三种成分均未标示。
食品药品监管局说明，双氯芬酸属于非甾体抗炎药，可增加心脏病发作、中风等严重心血管问题的风险，也可造成胃肠道出血、溃疡，甚至危及生命的胃肠穿孔，并可能与其他药物、尤其是其他含非甾体抗炎药成分的产品相互作用，显著放大副作用风险。地塞米松是类固醇药物，可削弱免疫系统、使身体更难抵抗感染，还可导致血糖升高、肌肉损伤与精神健康问题。美索巴莫是肌肉松弛剂，可引起嗜睡、头晕与低血压，使驾驶或操作重型机械变得不安全。
食品药品监管局建议，正在使用这两款产品的消费者应立即咨询医疗专业人员，以安全方式停用；类固醇停用的戒断风险也应由医疗专业人员评估。医疗专业人员与消费者可通过食品药品监管局 MedWatch 安全信息与不良事件报告计划报告相关不良反应，可在线提交，或下载表格后传真至 1-800-FDA-0178。
食品药品监管局表示，这类通知针对以膳食补充剂或普通食品名义销售、可能含有隐藏成分的产品，这类产品通常以止痛等用途推广、并常宣称为纯天然，消费者购买前应保持谨慎；该局也说明，其无法检测和识别市面上全部含有潜在有害隐藏成分的补充剂类产品。
FDA Warns Two Pain Products Contain Hidden Prescription Drug Ingredients: RX7 Articulaciones and Ort-Flx Sold Online
The U.S. Food and Drug Administration (FDA) issued two public notifications on October 28 advising consumers not to purchase or use RX7 Articulaciones and Ort-Flx. The products, promoted for joint and muscle pain and for pain and arthritis, are sold on various websites including eBay and may also be sold in some retail stores. FDA laboratory analysis confirmed that both products contain prescription drug ingredients not listed on their labels.
RX7 Articulaciones was found to contain diclofenac and dexamethasone. Ort-Flx was found to contain diclofenac, dexamethasone and methocarbamol, none of them listed on the label.
The FDA says diclofenac, a nonsteroidal anti-inflammatory drug, can increase the risk of serious heart problems such as heart attack and stroke, and can cause gastrointestinal bleeding, ulcers or life-threatening tears in the stomach or intestinal lining; it can also interact with other medications, especially other NSAID-containing products. Dexamethasone, a steroid, can weaken the immune system, raise blood sugar, and cause muscle damage and mental health problems. Methocarbamol, a muscle relaxant, can cause drowsiness, dizziness and low blood pressure, making driving or operating heavy machinery unsafe.
Consumers taking either product should immediately consult a health care professional to safely discontinue use, the FDA says, and the risks of withdrawal from corticosteroids should be assessed by a health care professional. Adverse events can be reported through the FDA MedWatch program, online or by fax at 1-800-FDA-0178.
The FDA says such notifications cover products marketed as dietary supplements or conventional foods with hidden ingredients, which are typically promoted for pain relief and often represented as all natural, and urges caution before purchasing them. The agency notes it is unable to test and identify all supplement products with potentially harmful hidden ingredients on the market.
来源：GSM·美国（原文链接）
图片来源：美国食品药品监管局白橡树园区一号大楼，公共领域
