(2000-2010 - death and serious patient outcomes from FDA approved drugs) "These data describe the outcome of the patient as defined in U.S. reporting regulations (21 CFR 310.305, 314.80, 314.98, 600.80) and Forms FDA 3500 and 3500A (the MedWatch forms). Serious means that one or more of the following outcomes were documented in the report: death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome. Documenting one or more of these outcomes in a report does not necessarily mean that the suspect product(s) named in the report was the cause of these outcomes."
Editor's Note: These data show "deaths" totaling 452,780 and "serious outcomes" equaling 2,816,297 occurred during the eleven years from 2000 to 2010 as tabulated from the FDA's Adverse Event Reporting System for prescription drugs.
Comparing the five years (2001-2005) with the five years (2006-2010) finds that the number of deaths grew by +66.7% for the second time frame as compared to first. For the same comparative spans, serious patient leaped by almost three quarters (+77.5%).
AERS1 Patient Outcomes by Year
Year Death Serious
2000 19,445 153,818
2001 23,988 166,384
2002 28,181 159,000
2003 35,173 177,008
2004 34,928 199,510
2005 40,238 257,604
2006 37,465 265,130
2007 36,834 273,276
2008 49,958 319,741
2009 63,846 373,535
2010 82,724 471,291
Total 2000-2010 452,780 2,816,297
Total 2001-2005 162,508 959,506
Total 2006-2010 270,827 1,702,973
% Chg +66.7% +77.5%
1 AERS = Adverse Events Reporting System. This system managed by the U.S. Food and Drug Administration (FDA) contains over four million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented as summary statistics. These summary statistics cover data received over the last ten years. These data are presented at the individual report level; some of the numbers may reflect duplicate reporting due to factors such as follow-up reports received on a case or different persons reporting on the same patient case.
Source:
"AERS Patient Outcomes by Year," Food and Drug Administration (Washington, DC: U.S. Department of Health and Human Services, March 31, 2010).
http://www.fda.gov/Drugs/GuidanceCompli ... on/Surveil...
(1998 - causes of death - adverse drug reactions) "Adverse drug reactions are a significant public health problem in our health care system. For the 12,261,737 Medicare patients admitted to U.S. hospitals, ADRs were projected to cause the following increases: 2976 deaths, 118,200 patient-days, $516,034,829 in total charges, $37,611,868 in drug charges, and $9,456,698 in laboratory charges. If all Medicare patients were considered, these figures would be 3 times greater."
Source:
C. A. Bond, PharmD, FASHP, FCCP, and Cynthia L. Raehl, PharmD, FASHP, FCCP, Department of Pharmacy Practice, School of Pharmacy, Texas Tech University Health Sciences Center, Amarillo, Texas, "Adverse Drug Reactions in United States Hospitals" Pharmacotherapy, 2006;26(5):601-608.
http://www.ncbi.nlm.nih.gov/pubmed/16637789
(1996 - causes of death - NSAIDS) "Each year, use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) accounts for an estimated 7,600 deaths and 76,000 hospitalizations in the United States." (NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, ketoprofen, and tiaprofenic acid.)
Source:
Robyn Tamblyn, PhD; Laeora Berkson, MD, MHPE, FRCPC; W. Dale Jauphinee, MD, FRCPC; David Gayton, MD, PhD, FRCPC; Roland Grad, MD, MSc; Allen Huang, MD, FRCPC; Lisa Isaac, PhD; Peter McLeod, MD, FRCPC; and Linda Snell, MD, MHPE, FRCPC, "Unnecessary Prescribing of NSAIDs and the Management of NSAID-Related Gastropathy in Medical Practice," Annals of Internal Medicine (Washington, DC: American College of Physicians, 1997), September 15, 1997, 127:429-438.
http://www.annals.org/content/127/6/429.full.pdf
Citing: Fries, JF, "Assessing and understanding patient risk," Scandinavian Journal of Rheumatology Supplement, 1992;92:21-4.
(1993-1999 - causes of death - emergency department visits, hospitalizations and deaths from acetaminophen-related liver injury) "... acetaminophen-related liver injury led to approximately
• 56,000 emergency department visits (1993–1999),
• 26,000 hospitalizations (1990–1999), and
• 458 deaths (1996–1998).
"Of these cases, unintentional acetaminophen overdose was associated with
• 13,000 emergency department visits (1993–1999),
• 2189 hospitalizations (1990–1999), and
• 100 deaths (1996–1998) (71 FR 77314 at 77318)."
Source:
Federal Register, "Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph," Vol. 74, No. 81, Wednesday, April 29, 2009, p. 19385.
http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf
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