Navigation Links
Study shows adverse drug events reported to the FDA have significantly increased
Date:9/10/2007

WINSTON-SALEM, N.C. A new study shows the number of drug-therapy related deaths and injuries reported to the U.S. Food and Drug Administration (FDA) nearly tripled between 1998 and 2005.

A researcher at Wake Forest University School of Medicine and colleagues reviewed serious and fatal drug events reported in that eight-year period to the FDA by consumers, health professionals and drug manufacturers, and found that serious adverse drug events increased 2.6-fold, from about 35,000 to nearly 89,000, and adverse drug-related deaths increased 2.7-fold, from about 5,500 to more than 15,000.

The study is reported in the Sept. 10 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

The FDA receives these reports of serious adverse drug events through its Adverse Event Reporting System. Better known to health professionals as MedWatch, this system has been in operation under the same database system since 1998, with consistent regulatory requirements for drug manufacturers.

The study also reported serious events increased four times faster than the total number of outpatient prescriptions during that period.

This marked increase of serious injuries from drug treatment is of great concern, said Curt Furberg, M.D., Ph.D., professor of public health sciences at Wake Forest University School of Medicine, and a co-author of the report. It shows current efforts to ensure the safety of drugs are not adequate, and that physicians and patients are unaware of these risks.

Furberg has previously called for far-reaching changes in drug safety regulation, including expanded authority for the FDA, higher priority for drug safety and new systems to monitor drugs once they are approved by the FDA.

The study found that a relatively small number of drugs accounted for the most reported serious adverse drug events, said Thomas J. Moore, A.B., of the Institute for Safe Medication Practices (ISMP), and the lead author.

The authors of this study took into account several factors that might influence their findings.

We saw no evidence that doctors and patients had become more active in reporting events in some across-the-board fashion, said Furberg. We also tried to eliminate noise in the reporting system, by excluding reports from more than 14 days after a drug was withdrawn. In addition, we excluded events that were not serious, and foreign reports to focus on U.S. risks.


'/>"/>

Contact: Shannon Koontz
shkoontz@wfubmc.edu
336-716-2415
Wake Forest University Baptist Medical Center
Source:Eurekalert

Related medicine news :

1. Rural Canadians travel far for specialists: study
2. A new study surpasses Gene Therapy Hurdle
3. Tomato Sauce reduces Cancer Risk- Study
4. A question on study of Adult Stem Cell
5. Study on obesity and heart failure
6. National Lung Study in the process
7. Marijuana gateway theory strengthened by study of twins
8. Old theory of adaptation confirmed by new study
9. Study casts doubt on keyboard ills
10. Gene study links endometriosis, infertility
11. Study reveals how stress can make you sick
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is ... emergency ambulance transport experience for the millions of people who require these medical ... the taxi industry through the use of technology. Now, SmartEMS has put forth ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet ... product that was developed to enhance the health of felines. The formula is all-natural ... two main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of ... recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at Work ... Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... , June 24, 2016 Research ... World Market for Companion Diagnostic Tests" report to their ... Market for Companion Diagnostics The World Market ... and personalized medicine diagnostics. Market analysis in the report includes ... Test Market (In Vitro Diagnostic Kits) by Region (N. America, ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
Breaking Medicine Technology: