BOX 2-5

Adverse Event Reporting in 2004

In 2004, FDA received 422,889 reports of suspected drug-related adverse events:

  • 21,493 MedWatch reports directly from individuals (patients or providers).

  • 162,107 manufacturer 15-day (expedited) reports.

  • 89,960 serious manufacturer periodic reports.

  • 149,329 nonserious manufacturer periodic reports.

SOURCE: FDA and CDER (2005).

Union, where electronic reporting to the European Medicines Agency has been mandatory since November 2005, over 90 percent of adverse reactions involving European-authorized medicines have been electronically reported by manufacturers.

ODS/OSE safety officers are expected to review the “15-day reports” when they arrive. They continually review incoming reports from MedWatch, redirecting those related to other regulated products, and contractors enter all the MedWatch reports into AERS. Some adverse events (AEs) from companies, such as those in periodic reports for drugs that have been approved for more than 3 years or those considered non-serious, are not are routinely entered into AERS.

The structure of the AERS database complies with a guidance issued by the International Conference on Harmonisation (ICH E2B). FDA codes AEs with a standardized international terminology, the Medical Dictionary for Regulatory Activities (MedDRA). AERS allows for the on-screen review of reports, the use of searching tools, and various output reports. FDA is making limited use of data mining software to identify early drug safety signals in the AERS database via automated searching.

AERS is an important component of the postmarket surveillance system, particularly for identifying unexpected and rare adverse events (Rodriguez et al., 2001). For example, aplastic anemia and the rare skin disorder Stevens-Johnson syndrome have been linked to drugs through AE reporting (FDA, 1994). However, AERS is not efficient in distinguishing between signal and noise from adverse events, such as heart disease, which has a high background rate in the population (see Chapter 4 for a more comprehensive discussion). Some of the limitations of AERS data are the lack



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