Twinject NEW Safety Information

Health Canada recently released an advisory that it had received 30 adverse event reports categorized as device malfunctions for Twinject since 2005. At Paladin we take these reports very seriously. Patients, caregivers and healthcare professionals rely on our product to help protect them in the event of an anaphylactic reaction. We are concerned about and regret any uncertainty these reports may cause.

At Paladin, patient safety is our highest priority. Any report of an adverse event is treated with the highest degree of urgency and is thoroughly investigated by our Quality Assurance team to rule out the possibility of any quality issue with our product.

Paladin would like to assure all Twinject users that our device has been extensively and regularly tested for quality and reliability, including testing of each manufacturing batch produced to ensure that it meets Health Canada’s discerning standards.

We have also thoroughly investigated every adverse event report that we have received. As a result of our investigations, we have found no reason to believe that there are any actual manufacturing or design issues with any Twinject auto-injector that would prevent it from functioning as expected.

When a potential problem is reported, Paladin attempts to retrieve the device for inspection. We have been successful in retrieving a majority of devices involved in adverse event reports. To date, after careful investigation of these retrieved units, we have found no evidence of a defect or any other mechanical reason that would have affected the proper functioning of any of the devices involved in an adverse event report.

Training is vital for anyone using an epinephrine auto-injector. Paladin has been committed to elevating the standards of training and support for patients and caregivers living with severe allergies since Twinject’s launch. Providing training has been and will continue to be a major focus for Paladin. For more information on how to use Twinject, please visit www.twinject.ca.

Paladin Labs is working with Health Canada to address any concerns that are raised about Twinject. Twinject continues to be available in pharmacies across Canada.

If you have any questions about Twinject, please contact our Medical and Scientific Information line at 1-888-550-6060.

For more information about the Health Canada advisory, please click here