OTTAWA, ONTARIO, Jul 14 (MARKET WIRE) --
Health Canada is advising Canadians of reported malfunctions with the
Twinject 0.3 milligram (mg) auto-injector and the Twinject 0.15 mg
auto-injector that may pose serious health risks to users.
Twinject is a pre-filled, single-use automatic injector containing an
epinephrine solution that is used for the emergency treatment of severe
allergic reactions, including anaphylaxis. The product is available in
two dosing strengths, 0.3 mg and 0.15 mg. The injector is designed to
administer one automatic injection, followed by a second dose by manual
injection if necessary.
Since Twinject was first marketed in Canada on August 1, 2005, Health
Canada has received 30 reports of malfunctions associated with the use of
either the 0.3 mg or the 0.15 mg dosage strength. Most cases were
reported to be life threatening and required either emergency room
visitation or hospitalization. Twenty eight patients recovered without
any major complications, and the outcome of the other two patients
remains unknown.
The following are the three main types of malfunctions that were reported:
1) the needle did not fire with the first dose;
2) the plunger did not depress when attempting to administer the second
dose; and
3) the needle was either bent or cracked.
In some cases, the auto-injector had a combination of malfunctions and
did not deliver any drug.
Patients are advised to periodically review the operating instructions
that accompany the product to ensure they remain informed of its proper
use and care. Educational material, including training DVDs and demos,
can be ordered free of charge from the manufacturer through the website
(http://www.twinject.ca/), or by phone at 1-877-894-6532. If patients are
still concerned about the use of the Twinject auto-injector, they are
encouraged to speak with their doctor or pharmacist.
Health Canada has been made aware that the manufacturer of Twinject made
changes to the product in 2007, and released modified products to the
Canadian market in November 2007 and in early 2008. The impact of the
changes on the use of the product has not yet been established.
Health Canada will continue to assess this issue and will be working with
the manufacturer to mitigate potential risks associated with this
product. Health Canada is monitoring adverse reaction reports suspected
of being associated with Twinject, and encourages Canadians to report
adverse reactions to the Department through its Canada Vigilance Program.
Consumers requiring more information about this Advisory can contact
Health Canada's public enquiries line at (613) 957-2991, or toll free at
1-866-225-0709.
To report a suspected adverse reaction to this product, please contact
the Canada Vigilance Program of Health Canada by one of the following
methods:
Telephone: 1-866-234-2345,
Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a
version that can be completed and submitted online, is located in the
MedEffect Canada (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php)
area of the Health Canada Web site.
Egalement disponible en francais
Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
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