FDA Receiving Many More Serious Adverse Events Reports

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Public Health;  Pharmacy / Pharmacist
Article Date: 10 Sep 2007 - 14:00 PDT

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Between 1998 and 2005 the number of reports about serious adverse events sent to the Food and Drug Administration (FDA) has more than doubled; total deaths linked to adverse drug events have also more than doubled, according to an article in Archives of Internal Medicine (JAMA/Archives).

The FDA's definition of a serious adverse event is one that results in death, a birth defect, hospitalization, disability, a life-threatening situation, or any intervention that was needed to prevent harm, 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.

Thomas J. Moore, A.B., Institute for Safe Medication Practices, Huntingdon Valley, Penn., and team examined reports of serious adverse events sent to the FDA through AERS during the period 1998-2005 - a total of 467,809 of them. In 1998 the annual number 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 increase.

The authors wrote "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."

1,489 drugs 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 time. 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."

The writers concluded that their data showed a significant increase in reported deaths and serious injuries linked with drug therapy over the study period. "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."

"Serious Adverse Drug 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
Click here to see abstract online

Written by: Christian Nordqvist
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