FDA to post risk summaries of approved drugs on new website

June 23, 2010

FDA announced that it will release risk summaries about medicines approved after September 2007 and post them quarterly to a publicly accessible website, Reuters reported.

FDA announced that it will release risk summaries about medicines approved after September 2007 and post them quarterly to a publicly accessible website, Reuters reported.

According to the agency, summaries for 26 drugs and vaccines that treat allergies, HIV, and blood pressure, among other conditions, have already been posted.

The information, which will be based on post-approval health reports from companies, consumers, and physicians, will be disseminated about a drug or biologic 18 months after the products approval or after 10,000 patients have used it, which ever comes later. This is part of the agency’s efforts to comply with the 2007 FDA Amendments Act.

To help identify possible safety issues, an FDA official said the agency also will conduct a broad review of adverse-event reports, medical studies, and research and utilization databases.

The public website will be used by FDA to post summaries of its findings and describe actions the agency is taking to address the safety concerns.

Officials said the website aims to help physicians and patients track drug safety risks and make informed decisions about various treatment options.

For more information, go to http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm090385.htm