The US Food and Drug Administration received a record number of complaints regarding drug side effects and other related health problems in 2004, according to a report in USA Today.
The newspaper says that there were 422,500 adverse-event reports from pharmaceutical companies, health professionals and patients, almost 14% more than were filed the year before, though the final total for 2004, expected later this year, is unlikely to be significantly different from the estimate given.
However the FDA believes that the increase in adverse events is simply a result of the fact that there are more pharmaceuticals available. USA Today quotes Paul Seligman, director of the FDA’s Office of Pharmacoepidemiology and Statistical Sciences, as saying that “clearly, when you have more products on the market, you’re likely to have more side effects.”
Furthermore, he claimed that “more reports offer us an opportunity to detect safety concerns”, adding that the withdrawal of Merck & Co’s COX-2 inhibitor Vioxx (rofecoxib) at the tail-end of last year [[01/10/04a]], did not lead to a spate of fresh concerns.
Prescription drug sales reached a record $235 billion in the USA last year, according to IMS Health, up 8.3% 2003 and more than triple the figure in 1995.
Even Sidney Wolfe, director of the influential US consumer group Public Citizen’s Health Research Group and a tireless critic of the FDA, a Washington-based consumer watchdog, agreed that increased use of prescription drugs offered an explanation for the rise in complaints. However, he is quoted as saying: “There’s [now] much more public awareness of the potential for drugs to cause adverse reactions.”