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AstraZeneca, Ema: new unwanted effect to be included in the leaflet

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Capillary permeability is added in the leaflet among the undesirable effects of the AstraZeneca vaccine, which has returned to the spotlight in Italy for rare cases of thrombosis after the administration of the first dose. The Prac Pharmacovigilance Committee of the European Medicines Agency (EMA) decided that capillary leak syndrome should be “added to the ‘Product Information’ as a new side effect of AstraZeneca’s Covid vaccine, Vaxzevria, along with a ‘warning to raise awareness among health professionals and patients on this risk “, Ema communicates, based on the conclusions reached by the experts of the EU body in the meeting that was held from 7 to 10 June. The PRAC carried out a thorough review of 6 cases of capillary leak syndrome in people who had received Vaxzevria. Most cases occurred in women and within 4 days of vaccination. Three of those affected had a history of capillary leak syndrome and one of them subsequently died. As of 27 May 2021, more than 78 million doses of the AstraZeneca vaccine have been administered in the EU / European Economic Area and the UK. People who have been vaccinated with this shield product, the EMA warns, “should seek immediate medical attention if they experience rapid swelling of the arms and legs, or sudden weight gain, in the days following the vaccination. These symptoms are often associated with feeling faint (due to low blood pressure) “. The PRAC will continue to monitor cases related to the syndrome and will take all further necessary actions.

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