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Side effects of drugs on the rise
in US
12 September, 2007
The number of serious side effects and
deaths caused by drugs reported to the
United States Food and Drug
Administration (FDA) more than doubled
over an eight-year period.
The FDA had initiated a system in 1998
to make it easier to report
significant side effects of drugs.
According to an analysis of
adverse-drug events reported to the
FDA as a part of the agency’s MedWatch
reporting system, drug companies,
health care professionals, and the
public can file reports when they
think that a drug is connected to a
side effect or fatality. Drug
companies are required to file such
reports, while they are voluntary for
health care professionals.
The study has been published in the
September 10, 2007 issue of the
Archives of Internal Medicine.
The study says that 20% of drugs
accounted for 87.1% of adverse
effects, and the biggest offenders
were painkillers and drugs that modify
the immune system to treat arthritis.
A fourth of the increase could be
attributed to a boost in prescriptions
and another 15% to the introduction of
new biotechnology drugs since 1998.
The rest of the increase could not be
explained, according to Thomas Moore,
drug safety expert of the Institute
for Safe Medication Practices in
Huntingdon Valley, Pasadena.
Moore, who led the study, added: “The
clear finding is that we are losing
ground in terms of drug safety, and
that ought to be of great concern.”
The report is expected to add momentum
to reform the US federal government’s
monitoring of prescription drugs.
The report said the dramatic rise in
the ‘adverse events’ reported to the
FDA point to a multitude of problems
with the government’s monitoring of
drugs before approval and after they
are on the market. The study looked at
“serious adverse events,” which are
events that result in death or serious
injuries including birth defects,
disability, and hospitalization.
The report suggested that the FDA and
the health care system, including
doctors, hospitals and other
caregivers, are lacking in their
ability to manage medications.
Insulin, for example, was among the
top drugs cited for causing disability
or other “serious outcomes.”
Though specific reasons for adverse
events were not disclosed, the
report’s lead author said that
mismanagement of the medication could
cause low blood sugar, which can also
lead to balance issues, accidents, and
unconsciousness.
Moore and his colleagues analyzed all
of the serious adverse-event drug
reports submitted to the FDA through
its Adverse Event Reporting System,
commonly known as MedWatch reports.
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