Information Update - Benzocaine health products: new risk statements to be added to product labels

OTTAWA, April 5, 2012 /PRNewswire/ - Health Canada is informing Canadians that it has requested companies to add new risk statements to the packaging and labelling of licensed benzocaine products. In April 2011, Health Canada reminded Canadians of certain health risks associated with benzocaine products, including a very rare but serious blood condition known as methemoglobinemia that can affect sensitive individuals. The new statements are intended to further raise awareness of these risks and promote the safe use of benzocaine products.

As with any health product, Canadians are reminded to carefully read and follow the instructions for product use. If you or your child experience weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin, stop use of the benzocaine product and seek medical attention as these may be symptoms of methemoglobinemia. Speak to a healthcare practitioner if you have questions or concerns about a benzocaine product, particularly before use in a child under two years of age.

Products that contain the medicinal ingredient "benzocaine" are used in children and adults to relieve pain due to a variety of conditions, including: teething, sore throats, toothache,canker sores, mouth or gum irritation, itching, hemorrhoids, and as a first-aid treatment for burns and insect bites. Benzocaine is also used as a desensitizer in sexual enhancement products.

Most benzocaine products are available over-the-counter in a range of formulations including gels, sprays, swabs, liquids, lotions, lozenges , while a small number require a prescription from a healthcare practitioner. Benzocaine products are also used in healthcare settings during surgical, dental and other medical procedures to numb the mouth and throat.

The label changes apply to all benzocaine products except lozenges (as the risk of methemoglobinemia has not been associated with lozenges). See below for a list of affected benzocaine products.

New risk statements:

The new risk statements provide added instructions with respect to the risk of methemoglobinemia and for safe product use, including the importance of using the smallest amount possible. In addition, they provide guidance on recognizing the signs and symptoms of methemoglobinemia, and child safety.

• Stop use and consult a healthcare practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
• Do not use in large quantities or over large areas of the body (OR, Use smallest amount possible to achieve desired result).
• Do not use if allergic to benzocaine or any other ingredient in the product.
• Keep out of reach of children.
• Use with caution in children. [For all products except those intended for use in children under two years old]
• Consult a healthcare practitioner prior to use for children less than 2 years of age. [For products intended for use in children under two years old, such as oral teething gels or body lotions]

Some products may already contain information to this effect. Health Canada is requesting companies add the above statements to product packages and labels if they do not already appear, to ensure consistency in the labelled information and to help consumers use these products more safely. Exact wording for some statements may vary depending on product type.

Companies will be implementing the label changes over the next six months. During this time, products that may not have the updated precautionary statements can remain available on store shelves.

How to report side effects to health products to Health Canada

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Affected benzocaine products currently approved in Canada

** Affected benzocaine health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), or a Natural Product Number (NPN) on the label. Some benzocaine natural health products may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing the application for licensing.

Related Health Canada Web content:

• Information Update (April 18, 2011): Health Canada reminds Canadians of health risks associated with topical benzocaine products
• Advisory (November 24, 2006): Health Canada advises Canadians of health risks involved with using benzocaine
• Notice to Hospitals (November 23, 2006): Benzocaine Sprays with Methemoglobinemia

SOURCE Health Canada