Summary Safety Review - Topical Antiseptic Non-Prescription Chlorhexidine Products - Assessing the Potential Risk of Serious Allergic Reactions (hypersensitivity reactions)

May 13, 2016

Product

Topical antiseptic non-prescription chlorhexidine products

Potential Safety Issue

Serious allergic reactions (hypersensitivity reactions)

Key Messages

• Chlorhexidine is used in non-prescription topical antiseptic products to kill harmful bacteria on the skin and to reduce the risk of infection.
• This safety review was triggered when Health Canada identified published cases of serious allergic reactions, including anaphylaxis, linked with the use of topical chlorhexidine, during routine health product monitoring.
• Health Canada’s safety review determined that topical chlorhexidine may cause serious allergic anaphylactic reactions in certain conditions when used in the mouth, on open wounds, or immediately before or during surgery.  Health Canada’s Antiseptic Skin Cleansers monograph already requires that the labelling for chlorhexidine-containing hand cleansers include warnings against using the product on persons who are allergic to the ingredients. Health Canada will work to update the product information with these new findings.

Overview

This safety review was carried out to look at the potential link between non-prescription topical antiseptic chlorhexidine products and serious allergic reactions, and to determine if there is a need for additional labelling requirements. This issue came to light when Health Canada found published cases of serious allergic reactions linked with the use of topical chlorhexidine, during routine health product monitoring.

Symptoms of a serious allergic reaction, including anaphylaxis, may include itchy hives with swelling of the face, eyes, lips, mouth or throat; difficulty breathing; throat tightness or hoarseness; and fainting. An anaphylactic reaction is a serious and potentially life-threatening hypersensitivity reaction.

Use in Canada

• Non-prescription chlorhexidine products are applied to the skin (topically) as an antiseptic in order to reduce the risk of bacterial infection.
• There are over 50 non-prescription topical chlorhexidine products for human use in Canada.
• In Canada, chlorhexidine may be sold as a non-prescription drug for topical use at concentrations of 2-4%, and these products are available in forms such as creams, liquids, gels and sprays. Chlorhexidine products used in the mouth (orally), such as mouthwashes, are available by prescription only.

Safety Review Findings

• At the time of this review, Health Canada had received 53 reports of serious allergic reactions with the use of non-prescription topical chlorhexidine products. Of these, 3 were anaphylactic reactions.
• There are also published case reports of serious allergic reactions, including anaphylaxis, with non-prescription topical chlorhexidine products.
• Allergic reactions, including anaphylaxis, are a known risk with prescription oral chlorhexidine products and are already included in the Canadian prescribing information.
• Serious allergic anaphylactic reactions to non-prescription topical chlorhexidine products are not common. Health Canada’s safety review determined that topical chlorhexidine may cause serious allergic anaphylactic reactions in certain conditions when used in the mouth, on open wounds, or immediately before or during surgery.

Conclusions and Actions

• Health Canada’s safety review determined that topical antiseptic chlorhexidine products may cause serious allergic reactions. These findings suggest that some conditions may increase the risk of anaphylaxis, such as using chlorhexidine in the mouth, on open wounds, or immediately before or during surgery.
• Health Canada’s Antiseptic Skin Cleansers monograph already requires that the labelling for non-prescription topical chlorhexidine products include a warning statement to minimize the risk of allergic reactions. Health Canada will work to update the product information with these new findings.
• Health Canada continues to monitor side effect information involving chlorhexidine, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.