alexa Messages about black-box warnings: a comparative analysis of reports from the FDA and lay media in the US.
Pharmaceutical Sciences

Pharmaceutical Sciences

Pharmaceutical Regulatory Affairs: Open Access

Author(s): Yong PL, Bigman C, Flynn DN, Mittermaier D, Long JA

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Abstract BACKGROUND: The US FDA and lay media are important sources of information for the public about the risks of adverse events associated with drugs, yet the quality of FDA and US lay media reports about medication 'black-box' warnings, which highlight potentially severe adverse events from medications, is unknown. OBJECTIVE: To determine and compare the content of FDA and US lay media reports about medication black-box warnings. METHODS: We assessed FDA and US lay media reports about medication black-box warnings published or aired between 1 January 2003 and 31 December 2007 for the presence of six core message components, including (i) the affected drug's brand name; (ii) generic name; (iii) treatment indication; (iv) reason for the black-box warning; (v) clinical recommendations for patients, such as warning signs and symptoms of the adverse effect addressed by the black-box warning; and (vi) encouragement to discuss the issue with a healthcare provider, and additional characteristics. RESULTS: FDA reports presented more core information than lay media reports (median 5 vs 3 message components; p < 0.001). FDA reports were more likely to mention generic names (84.6\% vs 18.1\%; p < 0.001) of affected drugs, while lay media reports less frequently detailed clinical recommendations for patients (43.9\% vs 96.2\%; p < 0.001). Only 10.6\% of lay media reports encouraged patients to seek additional information from their healthcare provider, compared with 48.1\% of FDA reports (p < 0.001). CONCLUSIONS: FDA and US lay media reports about medication black-box warnings presented different information. This may reflect a difference in underlying motivation for reporting of news about risks of adverse drug events. It may also indicate a lack of agreement and understanding about the best methods to communicate risk information to the public, thus indicating areas for future research. This article was published in Drug Saf and referenced in Pharmaceutical Regulatory Affairs: Open Access

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