2004 FDA drug complaints way up high

The Food and Drug Administration (FDA) received a record number of complaints regarding drug side effects and other related health problems in 2004, according to a published report.

There were 422,500 adverse-event reports from pharmaceutical companies, health professionals and patients, almost 14 percent more than the 370,887 reports filed in 2003; the 2004 total, expected later this year, is not predicted to vary significantly from this estimate.

The year 2004 saw increased demands and questions about prescription drug safety. A senior FDA official Paul Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Sciences, says 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, and clearly, when you have more products on the market, you're likely to have more side effects.

Prescription drug sales reached a historic high totaling $235 billion nationally in 2004, up 8.3 percent from 2003 and more than triple the 1995 volume, according to IMS Health, a pharmaceutical market research firm.

Most 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 on a voluntary basis. Consequently the annual totals are believed to reflect only a percentage of the actual number of serious drug reactions and problems.