Summary Safety Review - Over-the-Counter Topical Pain Relievers Containing Menthol, Methyl Salicylate or Capsaicin - Assessing the Risk of Serious Skin Burns

February 13, 2017

Product

Over-the-counter topical pain relievers containing menthol, methyl salicylate or capsaicin

Potential Safety Issue

Risk of serious skin burns

Key Messages

• Over-the-counter (OTC) topical pain relievers are authorized for sale in Canada to relieve pain in muscles or joints, when applied on the skin.
• Health Canada first carried out a safety review in 2013 to assess the risk of rare but serious skin burns with the use of OTC topical pain relievers containing menthol, methyl salicylate or capsaicin. Its conclusion and action was to request additional safety information from certain manufacturers of select OTC topical pain relievers containing these ingredients. This review is a follow-up assessment on the safety issue and includes new data provided by the manufacturers.
• Health Canada's current review of the available information has established a link between the use of topical pain relievers containing menthol and the risk of rare but serious skin burns; however, there was not enough information to draw the same conclusions for the products containing methyl salicylate or capsaicin alone. Health Canada is updating the labelling standard for OTC topical pain relievers containing menthol alone or in combination, to inform about this risk.

Overview

In 2013, Health Canada carried out a safety review on the risk of rare but serious skin burns associated with the use of topical pain relievers containing menthol, methyl salicylate or capsaicin. Health Canada requested additional safety information from certain manufacturers of these products. This follow-up safety review assessed the information that was provided by these manufacturers, as well as additional information that Health Canada has gathered on this safety issue.

Use in Canada

• OTC topical pain relievers are authorized for sale in Canada to relieve pain in muscles or joints, when applied on the skin. These products, which may contain menthol, methyl salicylate or capsaicin, either alone or in combination, relieve pain by slightly irritating the skin surface. This irritation reduces the feeling of pain in the underlying joints and muscles.
• There are over 400 OTC topical pain relievers available for sale in Canada that contain menthol, methyl salicylate or capsaicin, either alone or in combination. These products are available in various forms including creams, gels, liquids, and patches.
• Some of these products already include safety information related to the risk of rare but serious skin burns.

Safety Review Findings

• At the time of the review, Health Canada had received a total of 29 unique Canadian reports of serious skin burns related to the use of OTC topical pain relievers containing menthol, methyl salicylate or capsaicin. The products were used as directed in 28 reports; in some reports, other factors may have played a role in the development of burns. In the remaining report, the product was not used as directed. Of these 29 reports, there were 7 reports involving products containing only menthol, 2 reports involving products containing only methyl salicylate, and 1 report involving a product containing only capsaicin. There were 19 reports involving products containing multiple ingredients, and most of these contained menthol and methyl salicylate together.
• The review of the safety information provided by manufacturers identified over 100 additional international reports of serious burns linked to the use of topical pain relievers. The majority of these cases contained menthol, alone or in combination with methyl salicylate. There were no cases of serious burns linked to the use of topical muscle and joint pain relievers containing methyl salicylate or capsaicin alone.
• In the medical literature, there is only one case of serious skin burns linked to the use of a topical pain reliever product containing menthol and methyl salicylate; however, the product was used inappropriately.

Conclusions and Actions

• Health Canada's current review of the available information has established a link between the use of topical pain relievers containing menthol and the risk of rare but serious skin burns; however, there was not enough information to draw the same conclusions for the products containing methyl salicylate or capsaicin alone.
• Health Canada is updating the labelling standard for all topical pain relievers containing menthol alone or in combination, to inform consumers about this potential risk, and that they should stop use of the product and get medical help right away if they experience severe skin reactions such as pain, swelling or blistering.
• Health Canada will continue to monitor safety information involving topical pain relievers containing menthol, methyl salicylate or capsaicin, as it does for all health products on the Canadian market, to identify and assess possible 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 these products both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.