Those direct-to-consumer ads for prescription drugs that include a long list of potentially harmful side effects give way to less scary commercials when the same meds become available over-the-counter. In other words, you may be led to believe that a medication is safer than it really is. That is the finding of a study by Jeremy A. Greene, MD, PhD of Brigham and Women's Hospital in Boston and colleagues that was published in the Journal of the American Medical Society.
"The US Food and Drug Administration (FDA) regulates prescription drug advertising, including requirements to provide consumers with a 'fair balance' of risks and benefits," the authors wrote. "When prescription drugs switch to over-the-counter (OTC) status, regulatory oversight of their advertising shifts to the Federal Trade Commission (FTC). Unlike the FDA, the FTC holds drug advertisements to the same standards as any consumer product: it applies a 'reasonable consumer' standard of truthfulness and nondeception that does not require any balancing of potential benefits and harms. Such a shift may be associated with changes in content."
The investigators analyzed all print and broadcast advertisements for four commonly used prescription drugs that were the subject of extensive direct-to-consumer promotion before and after OTC shift: loratidine (Claritin and others for allergies), omeprazole (Prilosec and others for acid reflux), orlistat (Alli and others for weight loss), and cetirizine (Aller-Tec and others for allergies). Television and print materials spanning 24 months before and six months following the OTC shift for each drug were obtained from an advertising database.
