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arznei-telegramm: e a-t 13 Sept. 2013

 


ANAPHYLACTIC REACTIONS WITH CHLORHEXIDINE (e.g. CHLORHEXAMED)

Due to recent reports, the Swiss Agency for Therapeutic Products, Swissmedic, draws attention to the rare, but potentially fatal risk of anaphylactic reactions related to the use of the disinfectant chlorhexidine (e.g. CHLORHEXAMED). Within the last 8 years, the regulatory authority has reviewed 18 reports concerning serious anaphylactic reactions caused by medicinal products containing chlorhexidine. Nine patients had reactions that were life threatening, and one patient died. Chlorhexidine had been used as a mouthwash, or for intra-urethral or topical application. A further six reports, from the last twelve years, of partially life-threatening anaphylactic reactions concern the use of medical devices, which had been previously cleaned with disinfectants containing chlorhexidine. The regulatory authority considers an increase in anaphylactic reactions to be probable, and assumes that only a proportion of the adverse reactions have been reported to them (1). The number of unreported cases might be considerable.

There have also been warnings on anaphylaxis due to chlorhexidine in other countries such as Great Britain (2), Australia (3) and New Zealand (4) in recent months. The German Federal Institute for Drugs and Medical Devices (BfArM), has overviewed a total of 105 reports of suspected anaphylactic or hypersensitivity reactions under chlorhexidine single-agent preparations since September 2003, 96 of which were classified as serious, and one of which was fatal. The authority wants shortly to publish a risk information (5). We advise against the indiscriminate use of chlorhexidine for sore throats or halitosis, for example, -Ed.



 

1

Swissmedic: HPC and anaphylactic reactions under chlorhexidine, 5 July 2013;
http://www.swissmedic.ch/marktueberwachung/00091/00092/02421/index.html?lang=de

 

2

MHRA: Medical Device Alert, 25 Oct. 2012;
http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con197920.pdf

 

3

Australian Prescriber 2012; 35: 101;
http://www.australianprescriber.com/magazine/35/3/article/1294.pdf

 

4

Prescriber Update 2013; 34: 22;
http://www.medsafe.govt.nz/profs/PUArticles/PDF/PrescriberUpdate_June2013.pdf

 

5

BfArM: letters dated 30 Aug. and 6 Sept. 2013



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