Formerly known as AERS (the Adverse Event Reporting System), FAERS is the FDA Adverse Event Reporting System. It is a tool used by the US Food and Drug Administration to track side effects of approved medications. The FDA explains, "The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products." (Prophylactic biologic products, or vaccines, are tracked in their own separate database, known as VAERS.)
FAERS is useful because drugs approved by the FDA may be less safe in practice than they appeared in the clinical trial reports submitted by their manufacturers. Even when potential safety signals are seen in clinical trial data submitted to the FDA, FDA reviewers sometimes accept explanations given by drug marketers and approve the drugs; FAERS provides valuable data that may confirm either the harmfulness of the drug or its relative safety. For example, the Medical Reviewer at the FDA who assessed the clinical trial data for Vioxx noted in 2001, "There is an increased risk of cardiovascular thrombotic events, particularly myocardial infarction, in the rofecoxib group compared with the naproxen group" in the study nicknamed VIGOR. However, because there was no true placebo group in the VIGOR study (no group receiving an inert substance), the FDA accepted Merck's explanation that "the difference in myocardial infarctions between the two groups is primarily due to the antiplatelet effects of naproxen." Later trial data demonstrated that the cardiovascular risk from Vioxx was inappropriate, and the manufacturer pulled the drug from the market. Although data from FAERS (then called AERS) was not used in the recall, it was used by researchers to identify an increased renal failure risk of some so-called COX-II inhibitors (including Vioxx) in 2002.
COX-II inhibitors and cardiovascular risk aside, the group of drugs for which FAERS may be the most useful is a large one, consisting of those therapeutic agents designated as "fast track" by the FDA. The "fast track" designation was created in 1997 by the Food and Drug Modernization Act of that year. The Code of Federal Regulations, Title 21, Section 312.80, provides the text of the regulatory process for fast-tracked drugs. Fast-tracked drugs, intended to be remedies for life-threatening or severely debilitating conditions, are granted several benefits, including consultation with the FDA early in the development process and a specialized risk-benefit analysis.
At least one group of fast-tracked drugs has already been shown to have potential safety signals missed during the clinical trial and approval process: antimicrobials. As discussed in a previous Examiner article, there is a growing threat of antibiotic-resistant bacteria due to inadequate hospital cleaning procedures, overprescription of antibiotics for humans, and feeding of antibiotics to healthy livestock. Because the threat of resistant microbes is perceived by the FDA to be so great, investigational antimicrobial agents are frequently fast-tracked. However, data discovered during post-marketing surveillance through FAERS points to previously unidentified adverse events associated with several antimicrobials, including an elevated risk of SIDS for users of darunavir (marketed as Prezista) and raltegravir (sold as Isentress). Research such as this points to both possible shortfalls of the current FDA approval process and to the importance of FAERS. Individuals and physicians can report adverse events of drugs to MedWatch by clicking here.