The US Food and Drug Administration has unveiled a scheme which will see the agency post summaries of safety analyses every quarter for recently approved treatments on its website.

Noting that some side effects may not become apparent until after a medicine has become available to a larger, more diverse population than the patients who participated in clinical trials, the FDA says the new summaries “provide a comprehensive look at safety data early in the product’s post-approval life cycle”. They include reports by manufacturers, providers and consumers, plus data from ongoing drug and biologic studies will also include “a brief discussion of any steps FDA may be taking to address these safety issues”.

The process fits in with part of the Food and Drug Administration Amendments Act of 2007, where the agency is required to prepare safety summaries within 18 months after a product’s approval or after it has been used by 10,000 patients, whichever comes later.

To start with, the agency released summaries for 26 treatments, including two vaccines, following evaluations completed through the fourth quarter of 2009. For the vast majority, no unlabelled or unexpected serious adverse events were identified and only GlaxoSmithKline’s Rotarix vaccine required a label change.

However, the FDA did receive reports related to drug ineffectiveness on Sepracor/Nycomed’s asthma treatment Alvesco (ciclesonide), describing problems with drug delivery, possibly due to device malfunction, after a period of use. The agency has asked the makers to “further investigate this issue”.

Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research, said “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”.