"Inactive" Ingredients in Pharmaceutical Products: Update (Subject Review)

Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement1recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qua...

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Bibliographic Details
Published in:Pediatrics (Evanston) 1997-02, Vol.99 (2), p.268-278
Main Author: Committee on Drugs
Format: Article
Language:English
Subjects:
Antiasthmatic agents
Biological and medical sciences
Complications and side effects
Excipients
Food coloring agents
Food colorings
Food colouring agents
General pharmacology
Labeling
Medical sciences
Miscellaneous
Nonprescription drugs
Pediatrics
Pharmacology. Drug treatments
Prescription drugs
Side effects
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Summary:Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement1recommending 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.
ISSN:0031-4005
1098-4275
DOI:10.1542/peds.99.2.268