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We also tried to eliminate noise in the reporting system, by excluding reports from more than 14 days after a drug was withdrawn.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:2/20/2017)... Mass. (PRWEB) , ... February 20, 2017 , ... ... delivery for regulated industries, announced Biscom Document Router (BDR), the first IoT device ... resolution lab diagnostics and imaging. Biscom will debut BDR at HIMSS17 ...
(Date:2/20/2017)... ... 2017 , ... Houston dentist , Dr. Nazari, announces ... his office, Antoine Dental Center. Emergency dentistry encompasses many treatments for emergencies affecting ... for serious complications and often experience severe pain. Not only does prompt treatment ...
(Date:2/20/2017)... ... February 20, 2017 , ... ... to purchase a new ultrasound-enhanced thrombolysis machine, a state-of-the-art device that breaks up ... facilitated by the Pepin Family Foundation. , “We greatly appreciate this gift from ...
(Date:2/19/2017)... , ... February 19, 2017 , ... ... to result in better care, and MEDfx and the Delaware Health Information Network ... Delaware. , As the nation’s first state-wide health information exchange, DHIN stores and ...
(Date:2/18/2017)... ... 2017 , ... Butler Mobility invited Ken Matthews to visit its manufacturing facility ... Ken was impressed with the safety and reliability of the Stannah Stairlift as well ... This endorsement by Ken Matthews can be heard on News Radio WHP 580 ...
Breaking Medicine News(10 mins):
(Date:2/20/2017)... , Feb. 20, 2017 Provides understanding ... and agreements entered into by the worlds leading ... https://www.reportbuyer.com/product/3605699/ Description The Global Renal Failure ... understanding and access to partnering deals and agreements ... - Trends in partnering deals ...
(Date:2/20/2017)... Systems Magnetic resonance imaging (MRI) ... the organs and tissues in the body with the ... technique does not use ionizing radiation either for the ... of cancer. MRI is used for a variety of ... orthopedics. Hence, MRI helps in the diagnosis and treatment ...
(Date:2/20/2017)... report analyzes the worldwide markets for Drug-Eluting Stents in US$ Million. ... Canada , Japan , Europe ... , and Rest of World. Read the ... ... 2015 through 2022. Also, a six-year historic analysis is provided for ...
Breaking Medicine Technology: