Other safety alerts
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| The United States: Janssen COVID-19 Vaccine: risk of immune thrombocytopenia |
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The US Food and Drug Administration (FDA) announces revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers. These revisions are in response to new safety information regarding the serious risk of immune thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.
Specifically, the Fact Sheet for Health Care Providers includes information about reports of adverse events following use of the vaccine which suggest an increased risk of ITP during the 42 days following vaccination, and that individuals with a history of ITP should discuss the risk and the potential need for platelet monitoring following vaccination with their healthcare provider. The Fact Sheet for Recipients and Caregivers includes additional information under the questions, “What should you mention to your vaccination provider before you get the Janssen COVID-19 Vaccine?” and “What are the risks of the Janssen COVID-19 Vaccine?” regarding ITP, as well as what to look for and when to seek medical attention.
The FDA and Centers for Disease Control and Prevention (CDC) continue to monitor the level of potential excess risk.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-11-2022
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 7 Aug 2021, with the latest update posted on 10 Nov 2021.
Ends/Wednesday, Jan 12, 2022
Issued at HKT 14:00
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