FDA Adds New Bleeding Disorder to List of Risks for J&J COVID-19 Vaccine

The FDA has added the rare bleeding disorder immune thrombocytopenia to the fact sheet listing risks associated with Johnson & Johnson’s COVID-19 vaccine.

In a letter to J&J’s subsidiary Janssen Biotech this week, the FDA said reports of adverse events following use of the vaccine suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination.

Immune thrombocytopenia occurs when the immune system mistakenly attacks platelets. Symptoms include easy bruising, bleeding, and pinpoint-sized reddish-purple spots on the lower legs.

In October, the European Medicines Agency recommended that the condition be added as an adverse reaction with an unknown frequency to the J&J vaccine product information.