Anvisa includes adverse events in the package insert of the drug baricitinib against Covid

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The National Health Surveillance Agency (Anvisa) informed, this Friday (3), about the publication of a letter to health professionals from the company Eli Lilly do Brasil about the inclusion of new data in the package insert of the drug Olumiant (baricitinib), against to Covid-19.

The change in the package insert adds a warning for possible Major Adverse Cardiovascular Events (MACE) and updates on the occurrence of venous thromboembolism and cancer, including lymphoma.

According to Anvisa, adverse events were identified from a clinical study and a retrospective cohort, which evaluated patients being treated for rheumatoid arthritis.

In a note, Anvisa said that the data should be considered before prescribing, being recommended to assess the benefits and risks of treatment with baricitinib for each patient.

Reference: CNN Brasil

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