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Drug complaints reach a record high
Reports to FDA up 14 percent in 2004, possibly due to surge in prescription
use.
By Kevin McCoy
USA Today
March 14, 2005
Drug side effects and other related health problems reported to the Food
and Drug Administration reached an all-time high in 2004, a government
estimate shows.
The federal agency received roughly 422,500 adverse-event reports from
pharmaceutical companies, health professionals and patients, up nearly 14
percent from the 370,887 reports filed in 2003. A final 2004 total is
expected later this year, but FDA officials don't expect it to vary
significantly from the estimate.
The bulk of the reports come from drug manufacturers, which the FDA
requires to file details of all known adverse events involving their
products. Doctors, nurses and patients also file, but their reports are
voluntary. As a result, the annual totals are believed to cover only a
percentage of the actual number of serious drug reactions and problems.
Although the 2004 increase occurred during a year that saw rising questions
about prescription-drug safety, a top FDA official said the agency believes
the rise reflects a surge in prescription drug use, not any increase in
health risk.
"There are more drugs on the market and more use of pharmaceuticals in
general," said Paul Seligman, director of the FDA's Office of
Pharmacoepidemiology and Statistical Sciences. "Clearly, when you have more
products on the market, you're likely to have more side effects."
Prescription drug sales totaled $235 billion nationally in 2004, a historic
high that was up 8.3 percent from 2003 and more than triple the 1995
volume, according to IMS Health, a pharmaceutical market research firm.
Sidney Wolfe, director of Public Citizen's Health Research Group, a
Washington-based consumer watchdog, agreed that increased use of
prescription drugs offered one explanation for the jump in adverse-event
reports. But he suggested that increased doctor and consumer understanding
of the power of prescription drugs could play an important contributing
role.
"There's much more public awareness of the potential for drugs to cause
adverse reactions," Wolfe said. "The whole concept of drug-induced disease
is much better known than it was 10 or 15 years ago."
Seligman said FDA analysts are examining the most recent data.
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