FDA drug complaints surge: report
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FDA drug complaints surge: report
A reported rise in complaints coincides with increased use of prescription drugs.

CNN/Money | March 14, 2005

NEW YORK - Complaints to the Food and Drug Administration regarding drug side effects and other related health problems reached an all-time high in 2004, according to a published report.

The federal agency received about 422,500 adverse-event reports from pharmaceutical companies, health professionals and patients, up nearly 14 percent from the 370,887 reports filed in 2003, reported USA Today . A final 2004 total is expected later this year, but FDA officials don't expect it to vary significantly from the estimate.

The 2004 increase occurred during a year that saw rising questions about prescription drug safety. However, a top FDA official said the rise reflects a surge in prescription drug use, not an 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.

The bulk of the reports to the FDA come from drug manufacturers, which are required by the FDA 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.

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