The U.S. Food and Drug Administration said it will provide information for patients and healthcare professionals on the safety of recently approved drugs and biologics on its website. The agency will post summaries of FDA safety analyses on recently approved products along with an outline of the steps the agency is taking to address any identified safety issues.

The new summaries will provide a look at safety data early in a newly approved product’s life cycle and are based on reports by manufacturers, providers, consumers and others to the FDA’s Adverse Event Reporting System and the Vaccine Adverse Event Reporting System maintained by the FDA and the Center for Disease Control and Prevention. The FDA will also draw information from periodic safety data submitted to FDA by manufacturers, information contained in the medical literature, and data from ongoing clinical studies.

 

“These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions about an individual’s health,” says Robert Ball, director of the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research.

 

Despite the use of clinical trials to determine the safety of medications before they are allowed to be marketed, some side effects may not become apparent until after a medicine becomes available to a larger, more diverse population than the patients who participated in studies prior to approval.

The FDA plans to include information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse events that occur more often than they did during clinical studies. The summaries will also include any steps FDA may be taking to address these safety issues.

By law, the FDA is required to prepare the safety summaries within 18 months after a product’s approval or after it has been used by 10,000 patients, whichever comes later.

“Conducting systematic, comprehensive, safety reviews of recently approved drugs and biologics provides an early detection mechanism for potentially serious risks and complements the FDA’s analysis of safety data during drug development and the agency’s routine monitoring of safety information after product approval,” says Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research.

Initial summary reports will contain information on drugs and biologics approved since September 2007. The summary reports will be located on an FDA web page that was first established in 2008 to serve as a portal for drug safety information.