Adverse drug events reported to FDA appear to have increased markedly

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Public release date: 10-Sep-2007

http://www.eurekalert.org/pub_releases/2007-09/jaaj-ade090607.php

Contact: Brehio

JAMA and Archives Journals

Adverse drug events reported to FDA appear to have increased markedly

The number of serious adverse drug events 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.

J. , 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.

“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.”

(Arch Intern Med. 2007;167(16):1752-1759. Available pre-embargo to the

media at www.jamamedia.org.)

Editor’s Note: Please see the article for additional information,

including other authors, author contributions and affiliations,

financial disclosures, funding and support, etc.

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