(Adds background on side effects)
Oct 1 (Reuters) - The European Union's drug regulator on
Friday identified a possible link between rare cases of blood
clotting in deep veins with Johnson & Johnson's COVID-19
vaccine and recommended the condition be listed as a side-effect
of the shot.
The European Medicines Agency also recommended that immune
thrombocytopenia (ITP), a bleeding disorder caused by the body
mistakenly attacking platelets, be added as an adverse reaction
with an unknown frequency to the J&J vaccine product information
and to AstraZeneca's vaccine.
J&J did not immediately respond to a request for comment.
Both vaccines have previously been associated with a very
rare combination of blood clotting and low platelet counts known
as thrombosis with thrombocytopenia syndrome (TTS).
The two products are based on harmless vector viruses that
instruct human cells to make a protein that primes the immune
system against future coronavirus infections.
EMA said the new, possibly life-threatening clotting
condition known as venous thromboembolism (VTE) to be included
on the J&J product label was separate from TTS.
VTE typically begins by a clot forming in a vein of a leg,
arm or groin, which then travels to the lungs and blocks the
blood supply there.
Regardless of any vaccine use, VTE is most commonly caused
by injury or lack of movement in bedridden patients. Birth
control pills and a number of chronic conditions are also seen
as risk factors.
(Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger
in Frankfurt
Editing by Maju Samuel and Frances Kerry)