Drug complaints to the FDA reach all-time highComplaints to the FDA about drug side effects and other health-related problems reached a record high in 2004, according to government estimates.
The agency received roughly 422,500 adverse-event reports from pharmaceutical companies, health professionals and patients, up nearly 14 percent from 370, 887 filed in 2003, the newspaper USA Today reported Monday.
A final total for 2004 is expected later in the year and is not expected to vary greatly from reported estimates, the newspaper report said.
A large portion of adverse-event reports came from drug manufacturers, which the FDA requires to file details of all known adverse events involving their products.
Doctors, nurses and patients also file voluntary reports. As a result, annual totals are believed to only cover a percentage of the actual number of serious drug reactions and problems.
Sidney Wolfe, director of the consumer watchdog group Public Citizen said that although the increased use of prescription drugs offer an explanation for the spike in adverse event reports, increased doctor and consumer understanding of the power of prescription drugs could have also played an important contributing role.
"The whole concept of drug-induced disease is much better known than it was 10 or 15 years ago," Wolfe told USA Today.