Benzocaine Product Labels Updated In Canada For Rare Blood Disorder

Benzocaine product labels have been updated in Canada for a rare blood disorder, Health Canada just announced. The agency advised Canadians that it has requested companies to add new risk statements to the packaging and labeling of licensed benzocaine products.

Last April, Health Canada reminded Canadians of certain health risks associated with benzocaine products, such as a rare, but serious, blood condition known as methemoglobinemia that can affect sensitive individuals. The new statements are meant to increase awareness about these risks and help promote the safe use of benzocaine products.

Health Canada reminds consumers to carefully read and follow the instructions for product use, and that if any person using a benzocaine product experiences weakness; confusion; headache; difficulty breathing; and/or pale-, gray- or blue-colored skin, use of the benzocaine product must be stopped and medical attention sought as these may be symptoms of methemoglobinemia. Health Canada also advises consumers to contact a healthcare practitioner with questions or concerns about benzocaine products, particularly before use in a child under the age of two.

Products that contain the medicinal ingredient “benzocaine” are used in children and adults to relieve pain due to an array of conditions such as for teething, sore throats, toothache, canker sores, mouth or gum irritation, itching, and hemorrhoids. These products can also be used as a first-aid treatment for burns and insect bites and 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, and lozenges; some require a prescription. Benzocaine products are also used during surgical, dental, and other medical procedures to numb the mouth and throat.

The label change applies to all but lozenge benzocaine products. The risk of methemoglobinemia has not been associated with these products. A list of affected benzocaine products can be accessed from the Health Canada web site here.

The new risk statements provide added instructions concerning the risk of methemoglobinemia and for safe product use, including the importance of using the smallest amount possible. The statements also provide guidance on child safety as well as on recognizing the signs and symptoms of methemoglobinemia. Companies will implement the label changes over the next six months; however, products without the new labeling may still be seen on store shelves.

The FDA first issued a warning about benzocaine and methemoglobinemia in 2006. Since, the agency said it has received reports of 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine, bringing the total to 319 cases as of last year. Most cases occurred in children aged two and under. The FDA warned that benzocaine products should not be used in children under two and adults should also use these products with caution, and not more than four times per day.

According to a prior Health Canada release, other side effects associated with topical benzocaine products include breathing or swallowing difficulties, a swollen tongue or mouth, irregular heartbeat, malaise, body twitching, hypersensitivity, burning, redness, itching, rash and irritation at the site. Symptoms of methemoglobinemia may include a pale, bluish or grayish pallor, shortness of breath, fatigue, confusion, lightheadedness, and rapid heart rate and can appear in minutes or hours following the application of a benzocaine product. Often, the condition occurs after just one application of the medication, the FDA said.

This entry was posted in Legal News and tagged . Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.