FDA对皮肤消毒剂葡萄糖酸氯己定（洗必泰）引起的罕见但严重的过敏反应发布警示

FDA对广泛使用的皮肤消毒剂葡萄糖酸氯己定（洗必泰）引起的罕见但严重的过敏反应发布警示。尽管罕见，但是有关此类产品引起严重过敏反应的报告数量近年来有所增加。因此，FDA要求含有葡萄糖酸氯己定的非处方药（OTC）消毒剂产品生产厂家在药物标签内增加警示信息。用于牙龈病的处方药（葡萄糖酸氯己定漱口水和口服片剂）已经在其药品标签中包含可能导致严重过敏反应的警示信息。

对于患者或者消费者来说，如果出现严重过敏反应的临床表现应该及时停用含有葡萄糖酸氯己定的产品，立即寻求专业的医疗帮助，或者拨打急救电话。这些反应可能在使用后数分钟内出现，主要症状包括气喘或严重的呼吸困难、严重的皮疹、休克等。

医疗专业人员在使用或推荐葡萄糖酸氯己定相关产品前应询问患者既往是否有对任何消毒剂的过敏史。告知患者如果使用葡萄糖酸氯己定相关产品后出现任何过敏症状都需立即寻求医疗帮助。如果患者有葡萄糖酸氯己定过敏史或者可疑过敏史，应该考虑诸如聚乙烯吡咯酮碘、酒精、苯扎氯铵、苄索氯铵、对氯间二甲苯酚等替代消毒剂。

葡萄糖酸氯己定是主要见于皮肤消毒的OTC产品，这些产品主要用于手术前的皮肤准备以减少可能导致皮肤感染的细菌。这种消毒剂为非专利产品，而且品牌众多，被制成溶液、洗手液、海绵、棉签等各种形式的产品。此外，葡萄糖酸氯己定还被作为处方药制成漱口水用于治疗牙龈病，制成口服药品用于治疗牙周病。1998年，我们向医疗专业人员发布了公共健康告知，对诸如辅料和静脉输液管等含有葡萄糖酸氯己定的医疗器械可能导致严重过敏反应的风险进行了警示。

FDA共发现了52例皮肤使用葡萄糖酸氯己定后出现严重过敏反应的案例。从1969年1月至2015年早期的46年间，FDA在全球范围内共收到了43例相关报告，其中超过一半的案例在2010年以后上报，是在我们1998年发布公共健康告知之后。这个数字只包括上报到FDA的报告，所以很有可能遗漏了一些案例。这些严重的过敏反应导致急诊室治疗或者住院治疗，共导致2起死亡。另外8个案例发现于1971至2015年出版的医学文献，1个案例发现于NEISS-CADES数据库（2004-2013）。

我们强烈建议患者、消费者、医疗专业人员上报有关葡萄糖酸氯己定的不良反应。

来源：http://www.fda.gov/Drugs/DrugSafety/ucm530975.htm

FDA Drug Safety Communication: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate

The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels.

Patients and consumers should stop using the product that contains chlorhexidine gluconate and seek medical attention immediately or call 911 if they experience symptoms of a serious allergic reaction. These reactions can occur within minutes of exposure. Symptoms include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, which is a life-threatening condition that occurs when the body is not getting enough blood flow.

Health care professionals should always ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product. Advise patients to seek immediate medical attention if they experience any symptoms of an allergic reaction when using the products. Consider using alternative antiseptics such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX) when any previous allergy to chlorhexidine gluconate is documented or suspected.

Chlorhexidine gluconate is mainly available in OTC products to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections. These products are available as solutions, washes, sponges, and swabs and under many different brand names and as generics (see Facts about Chlorhexidine Gluconate). Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease. In 1998, we issued a Public Health Notice to warn health care professionals about the risk of serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.

We identified 52 cases of anaphylaxis, a severe form of allergic reaction, with the use of chlorhexidine gluconate products applied to the skin. In the 46 years between January 1969 and early June 2015, FDA received reports of 43 cases worldwide.* More than half of the 43 cases were reported after 2010, and after our 1998 Public Health Notice. This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware. The serious allergic reaction cases reported outcomes that required emergency department visits or hospitalizations to receive drug and other medical treatments. These allergic reactions resulted in two deaths. Eight additional cases of anaphylaxis were published in the medical literature between 1971 and 2015,1-3 and one case was identified in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database between 2004 and 2013.

We urge patients, consumers, and health care professionals to report side effects involving chlorhexidine gluconate or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.