Drug Complaints Reach Record High

The above headline comes from the March 13, 2005 USA Today. The article starts by noting that in 2004 preliminary reports show that the Food and Drug Administration (FDA) has received roughly 422,500 adverse-event reports from pharmaceutical companies, health professionals and patients, up nearly 14% from the 370,887 reports filed in 2003.

The article noted that the FDA requires drug companies to report adverse drug reactions or events when they are made aware of them. However, doctors, nurses and patients also file reports, but their reports are voluntary. The result is that the number posted by the FDA only represents a portion of the actual drug adverse effects that occur in each year.

Paul Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Sciences suggests that the increase may not be due completely to an increase of adverse reactions, but also due to an increase in usage of drugs in general. He suggested, "There are more drugs on the market and more use of pharmaceuticals in general. Clearly, when you have more products on the market, you're likely to have more side effects."

According to IMS Health, a pharmaceutical market research firm, prescription drug sales totaled $235 billion nationally in 2004, this historic high represented an 8.3% increase from 2003 and is more than triple the volume just a decade ago in 1995.

Sidney Wolfe, director of Public Citizen's Health Research Group, a Washington-based consumer watchdog group partially agreed that the increase may be due in part to the increased usage of drugs but he suggested that awareness also played an important role to the increase in reports. He noted, "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."