July 14, 2008
REMINDER/Advisory: Reported Malfunctions With Twinject Auto- Injector Pose Potential Health Risks
OTTAWA, ONTARIO--(Marketwire - July 14, 2008) - 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.
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