PMID- 25255848
OWN - NLM
STAT- MEDLINE
DCOM- 20150831
LR  - 20220317
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 37
IP  - 11
DP  - 2014 Nov
TI  - Stimulated reporting: the impact of US food and drug administration-issued alerts 
      on the adverse event reporting system (FAERS).
PG  - 971-80
LID - 10.1007/s40264-014-0225-0 [doi]
AB  - BACKGROUND: The US Food and Drug Administration (FDA) uses the Adverse Event 
      Reporting System (FAERS) to support post-marketing safety surveillance programs. 
      Currently, almost one million case reports are submitted to FAERS each year, 
      making it a vast repository of drug safety information. Sometimes cited as a 
      limitation of FAERS, however, is the assumption that "stimulated reporting" of 
      adverse events (AEs) occurs in response to warnings, alerts, and label changes 
      that are issued by the FDA. OBJECTIVE: To determine the extent of "stimulated 
      reporting" in the modern-day FAERS database. METHODS: One hundred drugs approved 
      by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were 
      obtained by a comprehensive search of the FDA's MedWatch and main websites. 
      Publicly available FAERS data were used to assess the "primary suspect" AE 
      reporting pattern for up to four quarters before, and after, the issuance of an 
      FDA alert. RESULTS: A few drugs did demonstrate "stimulated reporting" trends. A 
      majority of the drugs, however, showed little evidence for significant reporting 
      changes associated with the issuance of alerts. When we compared the percentage 
      changes in reporting after an FDA alert with those after a sham "control alert", 
      the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed 
      for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated 
      an increase (greater than or equal to 1 %) in reporting. The long-term analysis 
      of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater 
      than or equal to 1 % increase. CONCLUSIONS: Our results suggest that most of 
      modern day FAERS reporting is not significantly affected by the issuance of FDA 
      alerts.
FAU - Hoffman, Keith B
AU  - Hoffman KB
AD  - AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA, 95403, 
      USA, keith@adverseevents.com.
FAU - Demakas, Andrea R
AU  - Demakas AR
FAU - Dimbil, Mo
AU  - Dimbil M
FAU - Tatonetti, Nicholas P
AU  - Tatonetti NP
FAU - Erdman, Colin B
AU  - Erdman CB
LA  - eng
GR  - R01 GM107145/GM/NIGMS NIH HHS/United States
PT  - Journal Article
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Humans
MH  - Product Surveillance, Postmarketing/*trends
MH  - Program Evaluation
MH  - United States
MH  - *United States Food and Drug Administration
PMC - PMC4206770
EDAT- 2014/09/27 06:00
MHDA- 2015/09/01 06:00
PMCR- 2014/09/26
CRDT- 2014/09/27 06:00
PHST- 2014/09/27 06:00 [entrez]
PHST- 2014/09/27 06:00 [pubmed]
PHST- 2015/09/01 06:00 [medline]
PHST- 2014/09/26 00:00 [pmc-release]
AID - 225 [pii]
AID - 10.1007/s40264-014-0225-0 [doi]
PST - ppublish
SO  - Drug Saf. 2014 Nov;37(11):971-80. doi: 10.1007/s40264-014-0225-0.