Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low

Health Affairs
Dongyi DuClark Nardinelli

Abstract

In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event...Continue Reading

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Citations

Jun 26, 2013·International Journal of Medical Sciences·Toshiyuki SakaedaYasushi Okuno
Mar 20, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ethan Basch
Jan 31, 2016·Gastroenterology Nursing : the Official Journal of the Society of Gastroenterology Nurses and Associates·Allison Salk, Eli D Ehrenpreis
Nov 16, 2019·Briefings in Bioinformatics·Xuan LinXiangxiang Zeng
Dec 14, 2019·Pharmacoepidemiology and Drug Safety·Helen W SullivanVictoria J Hoverman
Dec 28, 2017·Pharmacoepidemiology and Drug Safety·Linda M ParkRichardae T Araojo

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