> Do we really want to go back to the
> unregulated days of pharmaceutical marketing that were filled with
> unsubstantiated claims of great benefits?
http://archinte.ama-assn.org/cgi/content/short/167/16/1752
Serious Adverse Drug Events Reported to the Food and Drug Administration,
1998-2005
Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD
Arch Intern Med. 2007;167:1752-1759.
Background The US Food and Drug Administration has operated the Adverse
Event Reporting System since 1998. It collects all voluntary reports of
adverse drug events submitted directly to the agency or through drug
manufacturers.
Methods Using extracts published for research use, we analyzed all serious
adverse drug events and medication errors in the United States reported to
the Food and Drug Administration from 1998 through 2005.
Results From 1998 through 2005, reported serious adverse drug events
increased 2.6-fold from 34 966 to 89 842, and fatal adverse drug events
increased 2.7-fold from 5519 to 15 107. Reported serious events increased 4
times faster than the total number of outpatient prescriptions during the
period. In a subset of drugs with 500 or more cases reported in any year,
drugs related to safety withdrawals accounted for 26% of reported events in
that group in 1999, declining to less than 1% in 2005. For 13 new
biotechnology products, reported serious events grew 15.8-fold, from 580
reported in 1998 to 9181 in 2005. The increase was influenced by relatively
few drugs: 298 of the 1489 drugs identified (20%) accounted for 407 394 of
the 467 809 events (87%).
Conclusions These data show a marked increase in reported deaths and serious
injuries associated with drug therapy over the study period. The results
highlight the importance of this public health problem and illustrate the
need for improved systems to manage the risks of prescription drugs.
Author Affiliations: Institute for Safe Medication Practices, Huntingdon
Valley, Pennsylvania (Mr Moore and Dr Cohen); and Division of Public Health
Sciences, Wake Forest University School of Medicine, Winston-Salem, North
Carolina (Dr Furberg).
Maryse
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