EMA: Recommendations for Updated Drug Safety Information Nearly Doubled in 2014
Between 2013 and 2014, the European Medicines Agency nearly doubled, to 40 percent, the percentage of drug adverse event assessments that led to a recommendation for updated patient information on labeling, a new report says.
On seven occasions, the agency’s Pharmacovigilance Risk Assessment Committee recommended highlighting important new safety information to prescribers via direct communications to healthcare professionals — three more than in 2013.
Five of the assessed adverse events also led to changes in drug risk-management plans, the annual report to the European Parliament, Council and Commission says.
Overall, the EMA reviewed more than 2,000 potential safety signals in 2014, 87 percent of them originating in the EudraVigilance database.
Of the 2,000 potential signals, 90 were confirmed and assessed by PRAC, including 34 signals validated by the agency and 56 by member state authorities.
Read the report at www.fdanews.com/5-15-EMA-Report.pdf. — Jonathon Shacat