Featured Research

from universities, journals, and other organizations

Adverse Drug Events Reported To FDA Appear To Have Increased Markedly

Date:
September 12, 2007
Source:
JAMA and Archives Journals
Summary:
The number of serious adverse drug events reported to the US Food and Drug Administration more than doubled between 1998 and 2005, as did deaths associated with adverse drug events, according to a new report.

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.

Related Articles


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.

"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."

Reference: Arch Intern Med. 2007;167(16):1752-1759.


Story Source:

The above story is based on materials provided by JAMA and Archives Journals. Note: Materials may be edited for content and length.


Cite This Page:

JAMA and Archives Journals. "Adverse Drug Events Reported To FDA Appear To Have Increased Markedly." ScienceDaily. ScienceDaily, 12 September 2007. <www.sciencedaily.com/releases/2007/09/070910132853.htm>.
JAMA and Archives Journals. (2007, September 12). Adverse Drug Events Reported To FDA Appear To Have Increased Markedly. ScienceDaily. Retrieved March 31, 2015 from www.sciencedaily.com/releases/2007/09/070910132853.htm
JAMA and Archives Journals. "Adverse Drug Events Reported To FDA Appear To Have Increased Markedly." ScienceDaily. www.sciencedaily.com/releases/2007/09/070910132853.htm (accessed March 31, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Tuesday, March 31, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Soda, Salt and Sugar: The Next Generation of Taxes

Soda, Salt and Sugar: The Next Generation of Taxes

Washington Post (Mar. 30, 2015) — Denisa Livingston, a health advocate for the Dinι Community Advocacy Alliance, and the Post&apos;s Abby Phillip discuss efforts around the country to make unhealthy food choices hurt your wallet as much as your waistline. Video provided by Washington Post
Powered by NewsLook.com
UnitedHealth Buys Catamaran

UnitedHealth Buys Catamaran

Reuters - Business Video Online (Mar. 30, 2015) — The $12.8 billion merger will combine the U.S.&apos; third and fourth largest pharmacy benefit managers. Analysts say smaller PBMs could also merge. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com
S. Leone in New Anti-Ebola Lockdown

S. Leone in New Anti-Ebola Lockdown

AFP (Mar. 28, 2015) — Sierra Leone imposed a three-day nationwide lockdown Friday for the second time in six months in a bid to prevent a resurgence of the deadly Ebola virus. Duration: 01:17 Video provided by AFP
Powered by NewsLook.com
These Popular Antibiotics Can Cause Permanent Nerve Damage

These Popular Antibiotics Can Cause Permanent Nerve Damage

Newsy (Mar. 27, 2015) — A popular class of antibiotic can leave patients in severe pain and even result in permanent nerve damage. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins