[Pharmwaste] AP news article: U.S. reports of drug reactions triple

[Johnson, Emma (ECY)]

FYI

 

AP News  

Sep 11, 12:04 PM EDT

 

U.S. reports of drug reactions triple 

By LINDSEY TANNER 
AP Medical Writer

CHICAGO (AP) -- Reports of dangerous side effects and deaths from widely
used medicines almost tripled between 1998 and 2005, an analysis of U.S.
drug data found.

The number of deaths and serious injuries from prescription and
over-the-counter drugs climbed from 34,966 to 89,842 during the study of
reports to the Food and Drug Administration.

Potent narcotic painkillers including Oxycontin, sold generically as
oxycodone, were among 15 drugs most often linked with deaths in the
study. Drugs frequently linked with serious nonfatal complications
included insulin, the arthritis drugs Vioxx and Remicade, and the
antidepressant Paxil.

The report adds to recent criticism of FDA oversight on drug safety,
including its handling of serious problems connected with Vioxx, which
was removed from the market in 2004.

"This growing toll of serious injury shows that the existing system is
not adequately protecting patients and underscores the importance of
recent reports urging far-reaching legislative, policy and institutional
changes," the authors said.

The analysis appears in this week's issue of Archives of Internal
Medicine. Its authors are Thomas Moore and Michael Cohen of the
Institute for Safe Medication Practices, a nonprofit educational group
that analyzes drug safety issues; and Dr. Curt Furberg of Wake Forest
University School of Medicine.

They analyzed excerpts of reports on serious side effects received by
the FDA between January 1998 and December 2005. A total of 467,809
serious complications were found. Reported deaths nearly tripled, rising
from 5,519 to 15,107.

A disproportionate number of complications occurred in elderly patients.
Women were more often victims than men, 55.5 percent compared to 45.5
percent. Children were involved in 7.4 percent of the problems.

The FDA issued a statement saying it is aware of the growing number of
reported problems and takes them seriously, but the reason for the
increase "is not completely known."

"While some of this has to do with the increasing number of
prescriptions, there are clearly other factors responsible for this
increase, such as the increase in public attention to drug safety, and
use of the Internet to make it easier for the public to submit," Dr.
Gerald Dal Pan of the FDA's surveillance and epidemiology office said in
the statement.

Sen. Charles Grassley, an Iowa Republican and frequent FDA critic, said
the report is another indication that the FDA's review of drugs already
on the market "must be rigorous and timely."

 

http://hosted.ap.org/dynamic/stories/D/DRUG_REACTIONS?SITE=WHIZ&SECTION=
HOME&TEMPLATE=DEFAULT&CTIME=2007-09-11-12-04-07
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Emma Johnson

Solid Waste and Financial Assistance

Washington Department of Ecology

425-649-7266

ejoh461 at ecy.wa.gov <mailto:ejoh461 at ecy.wa.gov> 

 

 

 

 

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