'Inactive' ingredients in pharmaceutical products: Update (subject review)

Jr Berlin, D. G. McCarver, D. A. Notterman, R. M. Ward, D. N. Weismann, G. S. Wilson, J. T. Wilson, D. R. Bennett, J. Mulinare, I. A. Hoskins, P. Kaufman, M. J. Rieder, G. Troendle, S. J. Yaffe, C. J. Cote, S. J. Szefler, S. C. Smolinske

Research output: Contribution to journalReview article

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Abstract

Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.

Original languageEnglish (US)
Pages (from-to)268-278
Number of pages11
JournalPediatrics
Volume99
Issue number2
DOIs
StatePublished - Feb 1997

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

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    Berlin, J., McCarver, D. G., Notterman, D. A., Ward, R. M., Weismann, D. N., Wilson, G. S., Wilson, J. T., Bennett, D. R., Mulinare, J., Hoskins, I. A., Kaufman, P., Rieder, M. J., Troendle, G., Yaffe, S. J., Cote, C. J., Szefler, S. J., & Smolinske, S. C. (1997). 'Inactive' ingredients in pharmaceutical products: Update (subject review). Pediatrics, 99(2), 268-278. https://doi.org/10.1542/peds.99.2.268