The National Health Surveillance Agency (Anvisa) informed this Friday (3) the inclusion of serious adverse events in the package insert of the drug Olumiant (baricitinib), by the company Eli Lily do Brasil.
According to Anvisa, the change in the package insert includes the addition of a precautionary warning for the occurrence of major adverse cardiovascular events and an update on the occurrence of venous thromboembolism and malignancy, including lymphoma.
According to the agency, adverse events were identified based on a clinical study and a retrospective cohort study that evaluated patients being treated for rheumatoid arthritis.
“Prescribers should consider this data when evaluating the benefits and risks of baricitinib treatment for each patient,” he said.
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source https://pledgetimes.com/covid-19-anvisa-includes-serious-adverse-events-in-the-medicine-package-insert-istoe-money/
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