Number of Reports of Adverse Prescription Drug Events to FDA Reached Record High in 2004, Agency Says
Prescription drug side effects and related health problems reported to FDA reached a record high in 2004, according to agency estimates, USA Today reports. The number of adverse-event reports received by the agency rose to 422,500 in 2004, compared with 370,887 in 2003, a 14% difference, according to USA Today.
Drug makers, which are required by law to file details of all known health problems related to their products, represent the "bulk" of the reports in 2004, USA Today reports. Physicians, nurses and patients also can file reports, but they are not required by law to do so. The adverse-event estimates are "believed to cover only a percentage of the actual number of serious drug reactions and problems," USA Today reports.
Paul Seligman, director of the FDA Office of Pharmacoepidemiology and Statistical Science, said there was no "unusual acceleration" of reports filed after Merck's September 2004 withdrawal of its painkiller Vioxx. Seligman said, "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."
Sidney Wolfe, director of Public Citizen's Health Research Group, said he agrees that one explanation for the rise in adverse-event reports is increased medication use, but he added, "There's much more public awareness of the potential for drugs to cause adverse reactions" (McCoy, USA Today, 3/14).