FDA Receiving Many More Serious Adverse Events Reports
Posted by ~Ray @ 2007-11-07 18:30:09
The FDA’s definition of a serious adverse event is one that results in death a bring forth defect hospitalization disability a life-threatening situation or any intervention that was needed to prevent injure say the authors. These events are reported to the FDA through AERS (Adverse Event Reporting System - the reports are voluntary and are also known as MedWatch reports. Pharmaceutical companies are required to report all serious adverse events to the FDA hence many of them come from the manufacturers.
Practices. Huntingdon Valley. Penn. and team examined reports of serious adverse events sent to the FDA through AERS during the period 1998-2005 - a be of 467,809 of them. In 1998 the annual be was 34,966 while in 2005 it jumped to 89,842. Fatal adverse events (reported) totaled 5,519 in 1998 rising to 15,107 in 2005 - a 2.7-fold change magnitude.
The authors wrote “The overall relative change magnitude 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.”
were linked to the adverse events during 1998-2005. However. 51 drugs accounted for 43.6% (203,957) of all reported adverse events.
The authors said “Contrary to our expectations drugs related to safety withdrawals were a modest share of all reported events and declined in importance over measure. Among the most frequently reported drugs associated with fatal events we observed a disproportionate contribution of
problem and illustrate the need for improved systems to bring home the bacon the risks of prescription drugs.”
“Serious Adverse medicate Events Reported to the Food and Drug Administration. 1998-2005″ Thomas J. Moore. AB; Michael R. Cohen. RPh. MS. ScD; Curt D. Furberg. MD. PhD Arch Intern Med. 2007;167:1752-1759 move here to see abstract online[ADVERTHERE]Related article:
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