Knight Ridder Series Examines Off-Label Prescription Drug Use
In a recently published three-part series called "Risky Prescriptions," Knight Ridder/Charlotte Observer examined safety issues surrounding off-label use of prescription drugs, in which physicians prescribe medications for uses not specifically approved by the FDA. Summaries of the articles appear below.
- "As Unapproved Uses Multiply, So Do the Dangers": A six-month Knight Ridder investigation found that off-label use of prescription drugs is "flourishing in a climate created by aggressive drug company marketing, receptive doctors and limited federal oversight," Knight Ridder/Observer reports. In the past year, about 115 million prescriptions were written for uses not specifically approved, leading in some cases to patient injuries and deaths nationwide, according to Knight Ridder/Observer (Young/Adams, Knight Ridder/Charlotte Observer, 11/2).
- "Marketing Plays Big Role in Rising Off-Label Sales": A "symbiotic relationship between physicians and drugmakers in which sales representatives routinely sway doctors untrained in the basics of drug therapy" has led to "soaring" retail sales for off-label uses of drugs, according to Knight Ridder/Observer. Off-label prescriptions increased by 96% from 1997-1998 to 2002-2003, and top-selling off-label drug sales totaled $12.9 billion in the past year, Knight Ridder/Observer reports (Adams/Young, Knight Ridder/Charlotte Observer, 11/3).
- "Little Progress at FDA in Fixing Problem": Although FDA officials have acknowledged potential risks from off-label uses of drugs, the agency "has barely tried to curb" the problem, and the Bush administration appears to be "laying the groundwork for even weaker regulation," Knight Ridder/Charlotte Observer reports. In addition, the FDA is "hobbled by a conflicted mandate from Congress" in which the agency is instructed to expand access to drugs while regulating advertising, according to Knight Ridder/Observer (Adams/Young, Knight Ridder/Charlotte Observer, 11/4).