FDA警告：OTC局部肌肉关节止痛剂可致灼伤

圣路易斯(MD Consult)——2012年9月13日，美国食品药品管理局(FDA)发布了一则有关某些用于缓解轻度肌肉和关节疼痛的非处方(OTC)局部用产品的安全通报。已有报告指出，使用这些产品可导致少数患者用药部位严重皮肤损伤(1~3度化学灼伤)。

这些OTC局部用产品为含有薄荷醇、水杨酸甲酯或辣椒素的单一成分或复方制剂，剂型包括乳膏剂、洗剂、软膏剂和贴剂。这些产品以不同的商品名上市，包括Bengay、Capzasin、 Flexall、Icy Hot和Mentholatum。

对不同来源的报告进行审查后，FDA认定43例用药部位灼伤与使用含有薄荷醇、水杨酸甲酯或辣椒素等活性成分的OTC局部肌肉和关节疼痛止痛药有关。所有灼伤病例均得到医务人员的确认，严重程度为1度至3度灼伤，但多数病例的灼伤严重程度并未确认。许多患者在第1次使用后24 h内出现严重灼伤或水泡，有些灼伤患者出现严重并发症，需要住院治疗。大部分2度和3度灼伤患者使用了含有薄荷醇单一活性成分的产品或含有薄荷醇和水杨酸甲酯两种成分的产品，其中薄荷醇浓度＞3%，水杨酸甲酯浓度＞10%，少数病例与使用含有辣椒素的产品有关。

应告知正在使用OTC局部肌肉和关节止痛剂的患者如何正确使用这类产品，以及有关严重灼伤的风险。应避免用力包扎用药部位，不要在用药部位使用局部加热装置(加热垫、灯泡、热水袋或热水瓶)，以免增加严重灼伤风险。一旦患者用药部位皮肤出现疼痛、水肿或水泡，建议停止用药。

若在OTC局部肌肉和关节止痛剂使用过程中出现不良反应，应向报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On September 13, 2012, the US Food and Drug Administration (FDA) issued a notice concerning the safety of certain over-the-counter (OTC) topical products used for the relief of mild muscle and joint pain. Use of such products has been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, in the areas where the products were applied.

These OTC topical products are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin. The various formulations include creams, lotions, ointments, and patches. The products are marketed under various brand names including Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum.

After a review of reports from various sources, the FDA identified 43 cases of application-site burns associated with the use of OTC topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate, or capsaicin. The products associated with these cases include patches, balms, and creams. All cases in this series include burns that were confirmed by a health care professional. Reports of burns ranged from first-degree to third-degree, but in many cases, the degree of the burn was not specified. Many cases occurred after one application, with severe burning or blistering presenting within 24 hours of application. Some patients with burns experienced serious complications requiring hospitalization. A majority of the second- and third-degree burns were reported with the use of products that contained menthol as the single active ingredient or products that contained both menthol and methyl salicylate, where the concentration of the ingredients was greater than 3% menthol and 1

0% methyl salicylate. Few cases were associated with the use of a capsaicin-containing product.

Patients using OTC topical muscle and joint pain relievers should be counseled about appropriate use of the products and should be informed about the risk of serious burns. Areas of the skin where the product is applied should not be tightly bandaged, and patients should be told not to apply local heat (heating pads, lamps, hot water in bags or bottles) to the areas because doing so can increase the risk of serious burns. If a patient experiences pain, swelling, or blistering of the skin where such a product was applied, discontinuation is advised.

Adverse reactions experienced with the use of OTC topical muscle and joint pain relievers should be reported to the FDA's MedWatch Adverse Event Reporting Program.