FDA警告：膳食补充剂Reumofan Plus可能含有多种未申报成分

圣路易斯(MD Consult)——2012年6月1日，美国食品药品管理局(FDA)就使用Reumofan Plus的潜在风险发布警告。这是一种“天然”膳食补充剂，在一些零售店、跳蚤市场和多种网站中销售。该产品含有多种标签上未列出的活性药物成分，可能损害健康。

FDA对Reumofan Plus的一项实验室分析显示，该产品含有以下药物：

·双氯芬酸钠：一种需要处方的非甾体抗炎药(NSAID)，可能增加心血管事件和严重胃肠道不良事件的风险。

·美索巴莫：一种需要处方的肌松剂，可引起镇静、头晕、低血压，并可能导致精神损害，或损害驾驶车辆、操控机械等躯体功能。

Reumofan Plus的标签采用西班牙语，声称有助于治疗关节炎、肌痛、骨质疏松症、骨癌及其他疾病。该产品由Riger Naturals在墨西哥生产。FDA正在与墨西哥政府相关部门紧密合作以处理该问题。墨西哥卫生部已向公众发布警告，并要求Riger Naturals召回该产品。

根据FDA接到的不良事件报告，消费者出现的症状提示Reumofan Plus可能含有皮质激素。墨西哥卫生部发现，至少有1批该产品含有地塞米松。至少有1篇来自医务人员的报告证实，曾服用Reumofan Plus的患者出现肾上腺抑制。在长期或大剂量使用皮质激素后突然停用可导致疲乏、恶心、低血压、低血糖、发热、肌肉或关节痛、头晕及晕厥。

如果发现患者不明原因出现提示NSAID毒性、抑郁或使用/停用皮质激素的症状，医务人员应询问其是否曾使用Reumofan Plus或其他“膳食补充剂”。此外，医务人员应对已服用Reumofan Plus的患者进行评估，了解有无涉及双氯芬酸、美索巴莫和皮质激素的药物-疾病相互作用，并考虑采取皮质激素逐渐减量的治疗方法是否得当。

对于与使用Reumofan Plus有关的不良反应，应报告至FDA的MedWatch不良事件报告系统。

爱思唯尔  版权所有

ST LOUIS (MD Consult) - On June 1, 2012, the US Food and Drug Administration (FDA) issued a warning concerning the use of Reumofan Plus, a product marketed as a "natural" dietary supplement and sold through some retail outlets, flea markets, and various Internet sites. It contains several active pharmaceutical ingredients not listed on the label that could be harmful.

An FDA laboratory analysis of Reumofan Plus found that it contains the following drugs:

diclofenac sodium, a prescription nonsteroidal antiinflammatory drug (NSAID) that may increase the risk of cardiovascular events, as well as serious gastrointestinal adverse events; and
 

methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, hypotension, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.
 

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals. The FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

According to adverse events reports submitted to the FDA, consumers reported symptoms suggesting that some lots of Reumofan Plus may contain corticosteroids. The Mexican Ministry of Health discovered that at least 1 lot of the product contains the corticosteroid dexamethasone. At least 1 report from a health care professional confirmed a diagnosis of adrenal suppression in a patient with adverse events who had been taking Reumofan Plus. Abrupt discontinuation of corticosteroids after long-term or high-dose use can cause fatigue, nausea, hypotension, hypoglycemia, fever, muscle and joint pain, dizziness, and fainting.

Health care professionals are urged to ask about the use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate.

Adverse reactions experienced with the use of Reumofan Plus should be reported to the FDA's MedWatch Adverse Event Reporting Program.