Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions
AUDIENCE: Nursing, Surgery, Dentistry, Patient
ISSUE: 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. See the FDA Drug Safety Communication for a data summary.
As a result, FDA is 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.
BACKGROUND: 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. Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease.
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.
In 1998, FDA 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.
RECOMMENDATION: 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.
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.
Read the MedWatch alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm539575.htm
美國FDA發布警訊含chlorhexidine gluconate之皮膚用抗菌產品，雖罕見但可能會產生嚴重過敏反應，且近年來通報比例逐年增加。因此美國FDA要求含chlorhexidine gluconate之非處方藥(over-the-counter, OTC)抗菌產品需於仿單中增加此警訊。
Chlorhexidine gluconate作為消毒皮膚用途時為指示藥或非處方藥，常用於手術或注射前，以減少感染的機會，其相關產品包含溶液、洗劑、消毒海綿、消毒棉棒等，且有不同廠牌。作為口腔清潔用途時則為處方藥，如治療牙齦炎或牙周病之漱口水。
1998年美國FDA曾發布含chlorhexidine gluconate之醫材，例如：敷料或注射管路，可能會引起嚴重過敏反應。含chlorhexidine gluconate之處方藥，也已標示此嚴重過敏反應之警訊於仿單上。
因此美國FDA建議，醫療專業人員在開方或建議病人使用含chlorhexidine gluconate藥品時，須詢問病人是否曾對此類藥品有過敏反應。若曾懷疑或有對含chlorhexidine gluconate藥品過敏之相關紀錄，可考慮使用其他抗菌劑替代。例如：優碘(povidone-iodine)、酒精(alcohols)、benzalkonium chloride、benzethonium chloride或是parachlorometaxylenol (PCMX)。病人或消費者使用含chlorhexidine gluconate之藥品，若出現嚴重之不良反應，其症狀可能包含哮喘或呼吸困難、臉部腫脹、嚴重之紅疹或蕁麻疹甚至休克，通常於接觸藥品後幾分鐘內即發生。病人若出現任何嚴重過敏反應，須停止使用，並立即就醫。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm539575.htm
[Posted 02/03/2017]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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