Home » Covid: Ema, ‘abnormal thrombosis in list of very rare side effects J&J’

Covid: Ema, ‘abnormal thrombosis in list of very rare side effects J&J’

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Milan, April 20 (beraking latest news Health) – At its meeting today, Tuesday 20 April, the Prac Pharmacovigilance Committee of the European Medicines Agency Ema “concluded that a warning about blood clots should be added to the product information for the anti-Covid Janssen vaccine. unusual with low platelet levels. The PRAC also concluded that these events should be listed as very rare side effects of the vaccine. ” This is what the EMA reports in a note.

“Healthcare professionals and people who will receive the” Johnson & Johnson “vaccine should be aware of the possibility of very rare cases of blood clots associated with low blood platelets within 3 weeks of vaccination,” notes the Ema who examined 8 reported cases in the US of thrombosis associated with thrombocytopenia, out of over 7 million vaccinated with J&J.

In the information for healthcare professionals, the EMA explains that “these very rare types of thrombosis with thrombocytopenia” have been detected “at unusual sites”. Particular mention is made of cerebral venous sinus thrombosis and splanchnic vein thrombosis, as well as arterial thrombosis. And in one case the outcome was fatal. All occurred, within 3 weeks of vaccination, in people under the age of 60 and most were women. “As for the mechanism, practitioners are highlighted that” the vaccine is thought to trigger a response. immune system leading to a disorder similar to heparin-induced thrombocytopenia “and that” at this time, the pathophysiological mechanism has not been established “with certainty and therefore” it is not currently possible to identify specific risk factors “.

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Operators, the EMA invites, “must pay attention to the signs and symptoms of thromboembolism and thrombocytopenia in order to promptly treat those affected in line with available guidelines. Thrombosis associated with thrombocytopenia requires specialized clinical management. they must consult the applicable guide or consult specialists (hematologists, coagulation specialists) to diagnose and treat this condition. ” Then there is the chapter of information that vaccinators need to give: “Practitioners should tell people receiving the vaccine that they should see a doctor if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain, symptoms neurological such as severe and persistent headache and blurred vision, petechiae beyond the vaccination site after a few days “. The health professionals involved in administering the shield injections in the EU, the EMA informs, “will be sent a direct ‘Dhpc’ communication, which will also be published on a dedicated page on the Agency’s website”.

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