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Methods for estimating causal relationships of adverse events with dietary supplements.

Ide K, Yamada H, Kitagawa M, Kawasaki Y, Buno Y, Matsushita K, Kaji M, Fujimoto K, Waki M, Nakashima M, Umegaki K - BMJ Open (2015)

Bottom Line: Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events.Causal relationship assessment using prospectively collected data. 4 dietary supplement experts, 4 pharmacists and 11 registered dietitians (5 men and 14 women) examined 200 case reports of suspected adverse events using the modified Naranjo scale and the modified Food and Drug Administration (FDA) algorithm.Modified FDA algorithm: Fleiss' κ (95% CI) 0.622 (0.622 to 0.622).

View Article: PubMed Central - PubMed

Affiliation: Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.

No MeSH data available.


Related in: MedlinePlus

Modified Food and Drug Administration (FDA) algorithm.
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BMJOPEN2015009038F2: Modified Food and Drug Administration (FDA) algorithm.

Mentions: Details of the FDA algorithm have been described previously.16 The modified FDA algorithm is shown in figure 2. There was limited information included in the dietary supplement case reports, so the number of options for questions was changed from 2 to 3: ‘Yes’, ‘No’ and ‘Don't know’. The scale was structured with 4 primary questions and 5 branch questions. The contents of the main questions were as follows: (1) the temporal relationship; (2) changes in symptoms due to the dietary supplement being discontinued; (3) rechallenges and (4) objective evidence from laboratory tests such as a drug-induced lymphocyte stimulation test or patch test. Each of these questions had branch questions relating to: (1) existing clinical conditions; (2) objective evidence from laboratory tests such as a drug-induced lymphocyte stimulation test or patch test and (3) previous experiences of adverse events after taking the same or similar (eg, including the same ingredient) dietary supplement. Adverse event reports were assigned to one of the following probability categories on the basis of the answers to these questions: lack of information, unlikely, possible, highly possible, probable and highly probable.


Methods for estimating causal relationships of adverse events with dietary supplements.

Ide K, Yamada H, Kitagawa M, Kawasaki Y, Buno Y, Matsushita K, Kaji M, Fujimoto K, Waki M, Nakashima M, Umegaki K - BMJ Open (2015)

Modified Food and Drug Administration (FDA) algorithm.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4663420&req=5

BMJOPEN2015009038F2: Modified Food and Drug Administration (FDA) algorithm.
Mentions: Details of the FDA algorithm have been described previously.16 The modified FDA algorithm is shown in figure 2. There was limited information included in the dietary supplement case reports, so the number of options for questions was changed from 2 to 3: ‘Yes’, ‘No’ and ‘Don't know’. The scale was structured with 4 primary questions and 5 branch questions. The contents of the main questions were as follows: (1) the temporal relationship; (2) changes in symptoms due to the dietary supplement being discontinued; (3) rechallenges and (4) objective evidence from laboratory tests such as a drug-induced lymphocyte stimulation test or patch test. Each of these questions had branch questions relating to: (1) existing clinical conditions; (2) objective evidence from laboratory tests such as a drug-induced lymphocyte stimulation test or patch test and (3) previous experiences of adverse events after taking the same or similar (eg, including the same ingredient) dietary supplement. Adverse event reports were assigned to one of the following probability categories on the basis of the answers to these questions: lack of information, unlikely, possible, highly possible, probable and highly probable.

Bottom Line: Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events.Causal relationship assessment using prospectively collected data. 4 dietary supplement experts, 4 pharmacists and 11 registered dietitians (5 men and 14 women) examined 200 case reports of suspected adverse events using the modified Naranjo scale and the modified Food and Drug Administration (FDA) algorithm.Modified FDA algorithm: Fleiss' κ (95% CI) 0.622 (0.622 to 0.622).

View Article: PubMed Central - PubMed

Affiliation: Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.

No MeSH data available.


Related in: MedlinePlus