USFDA amends J&J vaccine fact sheet to include rare bleeding risk

The symptoms include easy bruising or tiny blood spots under the skin, or unusual or excessive bleeding, the USFDA said.

51
USFDA
Picture: Pixabay

Last Updated on January 14, 2022 by The Health Master

The US Food and Drug Administration (USFDA) yesterday amended the fact sheet for Johnson & Johnson’s C-19 vaccine to include a rare risk of immune thrombocytopenia, a bleeding disorder.

The regulator said in a letter to J&J‘s arm, Janssen Biotech Inc., that “reports of adverse events following use of the Janssen C-19 vaccine under Emergency Use Authorization (EUA) suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination,”

The symptoms include easy bruising or tiny blood spots under the skin, or unusual or excessive bleeding, the USFDA said.

The amendment fact sheet follows similar moves for the vaccine by other regulators, including that of the European Medicines Agency (EMA), in October.

Both the J&J and AstraZeneca vaccines, which are based on a similar platform, have previously been associated with another very rare combination of blood clotting and low platelet counts, known as thrombosis with thrombocytopenia syndrome.

The US Centers for Disease Control and Prevention also last month recommended Americans choose to receive one of two other authorized C-19 vaccines from Pfizer-BioNTech over J&J’s single-dose shot, due to the rare but sometimes fatal risk.

FDA raids 16 Medical Stores for violation of D&C Rules

Indian Pharma Firms get 210 out of 635 approvals from USFDA

USFDA gives tentative nod to Alembic for Dronedarone tablets

Confusion over Molnupiravir ? Let’s understand

DCGI raises alarm over suspected spurious Tocilizumab injections in India

Drug recall: Clobetasol Propionate Ointment recalled due to this reason

3rd booster shot of Covaxin shows positive responses

FDA asks Chemists and Hospitals to ramp up medicine supply

India to become hub for Covid-19 antiviral medicines

Latest Notifications regarding Pharmaceuticals

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news

Enter your email address:

Delivered by FeedBurner