WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Open this folder and view contentsRegulatory actions
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Close this folderMedical devices
View the documentChlorhexidine-impregnated medical devices - hypersensitivity reactions
View the documentPositron Emission Tomographic (PET) products - exemptions to CGMP: final rule revoked
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine

Chlorhexidine-impregnated medical devices - hypersensitivity reactions

United States of America. The Food and Drug Administration has alerted health care professionals to a potential for serious hypersensitivity reactions to chlorhexidine-impregnated medical devices.

Three types of medical devices have been approved recently that incorporate chlorhexidine in the composition of the device: intravenous catheters, topic antimicrobial skin dressings and implanted antimicrobial surgical mesh.

Although the antimicrobial properties of chlorhexidine are well known, it is not as well known that chlorhexidine has been associated with hypersensitivity reactions. Anaphylactoid and other types of reactions have been reported with chlorhexidine used topically, intra-urethrally, as a lubricant on urinary catheters and with chlorhexidine-impregnated catheters. These incidents have occurred in Japan, Switzerland, the United Kingdom, Australia and Malaysia, as well as the United States.

1. Immediate systemic hypersensitivity reactions to chlorhexidine gels/lubricants used during urological procedures have been reported in several countries.

2. Immediate systemic hypersensitivity reactions to central venous catheters. In Japan, 13 cases of anaphylactoid type adverse were reported while the patients were using central venous catheters impregnated with chlorhexidine. Tachycardia, hypotension and complains of chest pain were cited. One patient subsequently died, although the exact cause of death is unknown. The manufacturer voluntarily withdrew the product from the market in Japan on 19 August 1997. No reports have been received from other countries to date. [See DRS Alert No. 62: Central venous catheters recalled: anaphylactic shock (ArrowguardR: Arrow), 15 September 1997]

3. Other types of reaction. In a US study, six of 10 neonates weighing under 1 kg showed local hypersensitivity reactions to chlorhexidine gluconate-impregnated patches used to secure central venous catheters. Severe contact dermatitis was also reported in another US study in 7 neonates with this type of dressing. Two cases were reported in nurses which described occupation asthma due to chlorhexidine and alcohol aerosols, and bradycardia was reported in a neonate associated with a chlorhexidine spray used on the mother's breasts.

The FDA has made the following recommendations:

• If a patient exhibits an unexplained hypersensitivity reaction, check whether chlorhexidine was used or was impregnated in a medical device that was used.

• If you suspect a patient may have had a hypersensitivity reaction to a drug or medical device that contains a chlorhexidine compound, monitor the reaction carefully, provide immediate respiratory and/or cardiovascular support as needed, and discontinue the use of the drug or medical device as expeditiously as possible.

• Any hypersensitivity reactions to chlorhexidine should be reported.

Reference: FDA Public Health Notice, March 11, 1998.

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