Pharmacovigilance Risk Assessment Committee (PRAC)

EU lists rare nerve disorder as side effect of J&J Covid-19 vaccine

European Medicines Agency (EMA), Guillain-Barré Syndrome, Johnson & Johnson, Nerve Disease, Pharmacovigilance Risk Assessment Committee (PRAC), Rare Diseases, Side Effects

Europe’s medicines regulator added a rare nerve-degenerating disorder, Guillain-Barré syndrome, as a possible rare side effect from Johnson & Johnson’s Covid-19 vaccine after the European Medicines Agency reviewed 108 cases reported worldwide.

EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics

Antibiotics, Birth Defects, Blockbusters, Bones, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, FDA/Regulatory, Fluoroquinolones, Integrase inhibitors, Muscles, Nervous System, Pharmacovigilance Risk Assessment Committee (PRAC), Quinolone, Tendons

The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.

EMA warns hep C drugs could reactivate hep B

Blockbusters, EMA, FDA, FDA/Regulatory, Health, Hepatitis B, Hepatitis C, Labeling, Liver Cancer, Pharmacovigilance Risk Assessment Committee (PRAC), Reactivation, Shares

The European Medicines Agency warned for the second time in 2016 that some of the top-selling hepatitis C treatments could reactivate hepatitis B in patients.