Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.

Purpose: The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA's first experience with the receipt of electronic health record (EHR)-triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA's pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting.

Use of parenteral iron products and serious anaphylactic-type reactions.

Controversy exists about the safety of the parenteral iron dextran products, Dexferrum and INFeD, which have been associated with rare, serious anaphylactic-type reactions. In the United States, their product labels carry boxed warnings of this adverse event; some have called for the withdrawal from marketing of the higher molecular weight Dexferrum. Between 2002 and 2007, sales of Dexferrum, INFeD, and iron gluconate Ferrlecit declined 32.

Identifying patterns of adverse event reporting for four members of the angiotensin II receptor blockers class of drugs: revisiting the Weber effect.

Purpose: To evaluate the evidence for temporal reporting patterns, such as the Weber effect, in spontaneous post-marketing adverse event (AE) reports submitted to the Food and Drug Administration (FDA), for four members of the angiotensin II receptor blockers drug class (ARBs).

Methods: For losartan, valsartan, irbesartan, and candesartan, we evaluated temporal trends in reporting for the total number of AE reports, serious AE reports, and direct reports from consumers or health care providers (direct reports) to FDA. Reporting patterns were considered consistent with the Weber effect when the peak occurred 2 years after US marketing and the number of reports declined thereafter.

Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action.

Background: Warfarin sodium is widely used and causes bleeding; a review might suggest the need for regulatory action by the US Food and Drug Administration (FDA).

Methods: We accessed warfarin prescriptions from the National Prescription Audit Plus database of IMS Health (Plymouth Meeting, Pennsylvania), adverse event reports submitted to the FDA, deaths due to therapeutic use of anticoagulants from vital statistics data, and warfarin bleeding complications from national hospital emergency department data.

Results: The number of dispensed outpatient prescriptions for warfarin increased 45%, from 21 million in 1998 to nearly 31 million in 2004.

Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions.

Background: The Adverse Event Reporting System is the primary surveillance database used by the Food and Drug Administration for identifying postmarketing drug safety problems.

Methods: We analyzed all reports of suspected adverse drug reactions submitted to the Food and Drug Administration from the inception of the Adverse Event Reporting System database in 1969 through December 2002. We documented drug withdrawals and restricted distribution programs based on safety concerns.