Risperdal and Prozac are among top five subjects of adverse event reports to FDA in 1995.
Executive Summary
JANSSEN RISPERDAL ACCOUNTS FOR 2% OF POST-MARKETING ADE REPORTS to FDA, according to the agency's 1995 Annual Adverse Drug Experience Report released in late January by the Division of Pharmacovigilance and Epidemiology. The agency received 2,540 adverse event reports for Risperdal (risperidone) out of a total of 130,950 ADEs reported during 1995, making the antipsychotic the fifth most frequently mentioned "suspect" drug in the database.