The FDA has launched a new adverse event portal that enables drug developers, doctors and patients to search for safety red flags for approved drugs. This FDA Adverse Event Reporting System (FAERS) could offer a powerful post-marketing pharmacovigilance resource and a means of guiding preclinical drug development.

Prior to the unveiling of the new system, researchers had to download FAERS data sets and develop their own programmes to analyse the inputs. With the updated system, they can query the database online to generate reports for specific products and adverse events, over different time frames. The agency hopes that the increased transparency of the new system will spur stakeholders to submit more detailed and complete reports, increasing FAERS's utility further.

However, a team of academic and industry researchers cautioned earlier this year in eLife that the FAERS database is riddled with data problems. Due to the lack of data curation and standardization, for example, each drug has on average 16 different names in the system. The antidepressant fluoxetine had 378 synonyms. The descriptions of different adverse events also varied widely, and side effects tend to be reported more often when drugs are in the news, introducing a potential source of bias.

Nevertheless, the researchers concluded that with curation, FAERS offers an invaluable data set — even for preclinical drug discovery programmes. The same team of researchers showed in Nature in 2012 how computational analyses of drug structures could be used to discover novel toxicity liabilities for approved drugs. By comparing the chemical structures of novel candidates with those of approved drugs, and by feeding curated data from FAERS into this analysis, researchers may be able to discover possible toxicity red flags and mitigation strategies for preclinical candidates.