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Senior Citizen Health & Medicine
Senior Citizens Most Frequent Victims as Deadly Drug
Reactions Spiral Upward
Seniors are 12.6% of population but 33.6% of
serious adverse drug events
 Sept. 11, 2007 – Senior citizens represent a
disproportionate share of adverse drug events as the number of serious
outcomes reported to the U.S. Food and Drug Administration (FDA) more
than doubled between 1998 and 2005, as did deaths associated with
adverse drug events, according to a report in the September 10 issue of
Archives of Internal Medicine, one of the JAMA/Archives journals.
A serious adverse drug event, as defined by the
FDA, means an adverse event that resulted in death, a birth defect,
disability, hospitalization, or was life-threatening or required
intervention to prevent harm, according to background information in the
article.
Such events are voluntarily reported to the FDA
through its Adverse Event Reporting System (AERS) and known as "MedWatch"
reports. The reports come to the FDA directly or through drug
manufacturers, who are then required to forward them.
Thomas J. Moore, A.B., of the Institute for Safe
Medication Practices, Huntingdon Valley, Penn., and colleagues analyzed
serious adverse drug events reported to the FDA through AERS from 1998
through 2005.
During this period, a total of 467,809 serious
adverse events were reported. The annual number of reports increased
2.6-fold between 1998 and 2005, from 34,966 to 89,842. The number of
fatal adverse drug events increased from 5,519 to 15,107 in the same
time frame, a 2.7-fold increase.
"The overall relative increase was four times
faster than the growth in total U.S. outpatient prescriptions, which
grew in the same period from 2.7 billion to 3.8 billion," the authors
write.
A total of 1,489 drugs were associated with adverse
events, but a subset of 51 drugs that each had 500 or more reports in
any year accounted for 203,957 or 43.6 percent of the total adverse
event reports in the study.
Dangerous Drugs
|
Drugs
most often identified in fatal events.
In order of occurrences |
|
1 |
Oxycodone |
(OxyContin, etc.) |
|
2 |
Fentanyl |
(Duragesic, etc.) |
|
3 |
Clozapine |
(Clozaril) |
|
4 |
Morphine |
|
|
5 |
Acetaminophen |
(Tylenol) |
|
6 |
Methadone |
|
|
7 |
Infliximab |
(Remicade) |
|
8 |
Interferon beta |
(Avonex, Betaseron, Rebif) |
|
9 |
Risperidone |
(Risperdal) |
|
10 |
Etanercept |
(Enbrel) |
|
11 |
Paclitaxel |
(Taxol) |
|
12 |
Acetaminophen-hydrocodone |
(Vicodin, Lortab etc) |
|
13 |
Olanzapine |
(Zyprexa) |
|
14 |
Rofecoxib |
(Vioxx) |
|
15 |
Paroxetine |
(Paxil) |
|
Drugs most often identified in disability or serious outcomes.
In order of occurrences |
|
1 |
Estrogens |
|
|
2 |
Insulin |
|
|
3 |
Infliximab |
(Remicade) |
|
4 |
Interferon beta |
(Rebif, Betaseron, Avonex) |
|
5 |
Paroxetine |
(Paxil) |
|
6 |
Rofecoxib |
(Vioxx) |
|
7 |
Warfarin |
(Coumadin) |
|
8 |
Atorvastatin |
(Lipitor) |
|
9 |
Etanercept |
(Enbrel) |
|
10 |
Celecoxib |
(Celebrex) |
|
11 |
Phentermine |
(Pro-Fast) |
|
12 |
Clozapine |
(Clozaril) |
|
13 |
Interferon alfa |
(Alferon N, Infergen, Intron A, Roferon-A) |
|
14 |
Simvastatin |
(Zocor) |
|
15 |
Venlafaxine |
(Effexor) |
"Contrary to our expectations, drugs related to
safety withdrawals were a modest share of all reported events and
declined in importance over time," the authors write.
In the subset of 51 drugs with 500 or more reports
in a year, the percentage of reported events associated with drugs
related to safety withdrawals declined from 26 percent in 1999 to less
than 1 percent in 2005. "Among the most frequently reported drugs
associated with fatal events, we observed a disproportionate
contribution of pain medications and drugs that modify the immune
system."
"These data show a marked increase in reported
deaths and serious injuries associated with drug therapy over the study
period," they conclude. "The results highlight the importance of this
public health problem and illustrate the need for improved systems to
manage the risks of prescription drugs."
Age
A disproportionate share of adverse events occurred
among elderly patients, while fewer than expected were reported among
children younger than 18 years.
Children younger than 18 years accounted for 25.8%
of the total US population but accounted for just 7.4% of the reported
serious adverse events.
Persons 65 years and older constituted 12.6% of the
total US population but accounted for 33.6% of the reported serious
adverse events. After adjustment for more intensive medication use, the
33.6% of reported cases still exceeded the 23.6% expected.
Among the 15 drugs most frequently named in fatal
events, 7 were pain medications and 4 had primary effects on the immune
system. Among nonfatal serious events, the most frequently identified
drugs were of more varied classes. The number of serious adverse events
associated with 13 prominent biotechnology products grew 15.8-fold
during the period, from 580 in 1998 to 9181 in 2005
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