Health Canada is informing Canadians and healthcare professionals about changes to the product labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines. The Department is updating the label of the Janssen COVID-19 vaccine to provide additional information about the very rare risk of immune thrombocytopenia (ITP), an autoimmune condition, and the rare risk of venous thromboembolism (VTE) following vaccination. Health Canada is also updating the label of the Vaxzevria (AstraZeneca) COVID-19 vaccine to provide additional information about the very rare risk of thrombocytopenia, including the very rare risk of ITP, following vaccination.
Very rare cases of ITP, an autoimmune condition, have been reported internationally after receiving the Janssen COVID-19 vaccine. Similarly, cases of thrombocytopenia including ITP have been reported after receiving Vaxzevria. ITP is a disorder that can lead to easy or excessive bruising and bleeding. The bleeding results from unusually low levels of platelets the cells that help blood clot. These cases typically occur within the first four weeks after vaccination. Some of these cases occurred in individuals with a history of ITP. Cases with a fatal outcome have been reported abroad. Individuals should seek immediate medical attention if they develop symptoms, such as unexplained bleeding, unexplained bruising, or small purplish spots beyond the site of vaccination.
Rare cases of VTE have been reported following vaccination with the Janssen COVID-19 vaccine. VTE is a condition where a blood clot forms in a deep vein, usually in a leg, arm or groin, and may travel to the lungs causing a blockage of the blood supply, with possible life-threatening consequences. The risk of VTE should be considered for individuals who are at increased risk for thromboembolism. Healthcare professionals should be alert to the signs and symptoms of VTE. Individuals should seek immediate medical attention if they develop symptoms, such as shortness of breath, chest pain, leg pain, leg swelling, or persistent abdominal pain following vaccination.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/health-canada-updating-labels-janssen-and-vaxzevria-astrazeneca-covid-19-vaccines
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 11 Mar 2021, with the latest update posted on 2 Oct 2021.
Ends/Wednesday, Nov 10, 2021
Issued at HKT 14:00
|
