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Adverse
drug events reported to the FDA have
significantly increased
Newswise — 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withdrawn.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.”
Michael R. Cohen, R.Ph.,
M.S., Sc.D., president of ISMP, also
co-authored the study.
Wake Forest University
Baptist Medical Center is an academic health
system comprised of North Carolina Baptist
Hospital and Wake Forest University Health
Sciences, which operates the university’s
School of Medicine. U.S. News & World Report
ranks Wake Forest University School of
Medicine 18th in primary care and 44th in
research among the nation's medical schools.
It ranks 35th in research funding by the
National Institutes of Health. Almost 150
members of the medical school faculty are
listed in Best Doctors in America.
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