Patients need to check their device to confirm that it can be removed from the carrier tube with ease
OTTAWA, Sept. 28, 2018 /CNW/ -
IssuePfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This
According to the company, the device label has been improperly applied to a very small number of devices in a way that the device label may become stuck to the inside of the carrier tube. This could mean that the device does not slide out of the tube as easily as expected. The issue is with the device label, and not with the device itself or the drug that it delivers (epinephrine).
EpiPen and EpiPen Jr are used to deliver an emergency treatment of adrenaline (epinephrine) to patients who are at risk or have a history of life-threatening allergic reactions (anaphylaxis).
Products are not being recalled by Pfizer, as the risk can be mitigated easily by pharmacists and patients by checking devices before an emergency situation arises to make sure they slide easily out of their carrier tube.
According to the company, there have been no reports of malfunctions related to this issue in Canada.
Health Canada is reminding Canadians of the ongoing supply disruptions of EpiPen and EpiPen Jr auto-injectors and that an alternative product, Auvi-Q (0.3 mg and 0.15 mg), has been made available through an Interim Order.
Who is affected
What consumers should do
Pfizer Canada is advising consumers to check if their devices expire between April 2018 and October 2019 and, if so, to do the following:
Additional information for pharmacists and other health professionals:
What Health Canada is doingHealth Canada is monitoring this issue and the company's implementation of corrective measures to prevent this issue from reoccurring. Should additional safety issues be identified with these products, Health Canada will take appropriate action and inform Canadians as necessary.
BackgroundEpiPen and EpiPen Jr epinephrine auto-injectors are supplied in a carrier tube. The auto-injector is removed from the carrier tube before use by flipping open the cap and inverting the carrier tube to allow the auto-injector to slide out. In a very small number of cases, there is a possibility that the auto-injector may not easily slide out of the tube. This may slow or prevent the administration of epinephrine during an anaphylactic reaction. Although the chance of this occurring as a result of this issue is very rare, failure to administer epinephrine as soon as possible during an anaphylactic response could lead to patient disability or death. Harm is preventable by checking the device before it is needed, to make sure that it will be easily accessed during an emergency.
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SOURCE Health Canada
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