2011-176
December 23, 2011
For immediate release

OTTAWA - Health Canada is informing Canadians of Pfizer Canada's instruction for the correct use of EpiPen and EpiPen Jr., particularly the correct way to remove the blue safety caps. According to the company, it is important that the blue safety cap be removed by pulling the cap straight up while the device is held with the orange tip pointing downward. Pfizer states that inappropriate removal of the blue safety cap may prevent the device from working properly and potentially result in failure to deliver the drug.

Pfizer instructs that the blue safety cap should not be removed by pulling it sideways or bending and twisting it off and that the blue safety cap should not be removed until you need to use the EpiPen or EpiPen Jr.

EpiPen (0.3 mg epinephrine auto-injector) and EpiPen Jr (0.15 mg epinephrine auto-injector) are pre-filled, single-use auto-injectors containing an epinephrine solution that is used for the emergency treatment of severe allergic reactions, including anaphylaxis.

Pfizer recommends that consumers should continue to carry their EpiPen or EpiPen Jr. at all times, regularly review the instructions for how to use their product and check that it has not been unintentionally activated.

Health Canada recommends that consumers should consult with their healthcare practitioner with any questions or concerns regarding the use of their EpiPen or EpiPen Jr. Consumers may also contact the company directly at 1-800-463-6001 or check  the website for more information.

Canadians can be confident that Health Canada is working with Pfizer to inform Canadians and their health care practitioners regarding Pfizer's instructions for the safe use of these products. Should additional information be identified, Health Canada will take appropriate action and inform Canadians.

Any malfunction or serious or unexpected adverse reactions in patients receiving EpiPen or EpiPen Jr. should be reported to Health Canada and Pfizer Canada Inc. To report suspected adverse events to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

Complaints involving health products can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

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