The posting of this list is required under the FDA Amendments Act of 2007, which requires that the agency provide the public with any new safety information or "potential signals of serious risk" that have been identified from the review of the adverse event reports submitted to AERS, which it receives from health care professionals, patients, and pharmaceutical companies.
By cross analyzing case reports, reactions, indications and therapies on AERS with drugs, targets, metabolic enzymes and transporters, MASE enables the molecular analysis of adverse events information.
As of November 2005, when these cases were first discussed at a meeting of the same panel, 13 deaths in people aged 17 years and younger who were on oseltamivir had been reported to AERS, all from Japan.
The alert was prompted by a review of 38 cases of hypomagnesemia in patients on prolonged PPI therapy reported to the FDA's Adverse Event Reporting System and 23 cases reported in the medical literature (which included at least 8 of the AERS reports), which "suggests there is an association between serious adverse events related to hypomagnesemia and prolonged PPI use," the FDA said.
McGuffin said he is pleased by the findings from the first year of AERS, though he said the system definitely needs some tweaking, and more companies need to step up to their responsibility for reporting.
Since the February meeting, the FDA's Office of Drug Safety has searched the AERS database for reports of congenital eye disorders in association with citalopram, escitalopram, and other antidepressants.