Excipients and additives: hidden hazards in drug products and in product substitution

The excipients and additives in drug formulations have been described as inert because they do not have an active role in the prevention or treatment of particular ailments. This has led to the misconception among physicians, pharmacists, drug manufacturers and the public that excipients are harmles...

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Bibliographic Details
Published inCanadian Medical Association journal Vol. 131; no. 12; pp. 1449 - 1452
Main Authors Napke, E, Stevens, D. G
Format Journal Article
LanguageEnglish
Published Canada Can Med Assoc 15.12.1984
Subjects
Benzyl Alcohols - adverse effects
Child
Coloring Agents - adverse effects
Drug Compounding
Drug Hypersensitivity
Excipients - adverse effects
Flavoring Agents - adverse effects
Humans
Pharmaceutic Aids - adverse effects
Polyethylene Glycols - adverse effects
Propylene Glycols - adverse effects
Sulfites - adverse effects
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Summary:The excipients and additives in drug formulations have been described as inert because they do not have an active role in the prevention or treatment of particular ailments. This has led to the misconception among physicians, pharmacists, drug manufacturers and the public that excipients are harmless and unworthy of mention. In fact, pharmacists are allowed to substitute drug formulations, without regard to the excipients, as long as they ensure that the active ingredients in the substitute are the same as those in the formulation prescribed. The inappropriateness of the term inert is becoming increasingly apparent as evidence of adverse reactions--some fatal--to excipients mounts. The likelihood that some "active" constituents, particularly erythromycin, have been blamed for such reactions deserves to be investigated. The public deserves to be better protected. For example, the United States has legislation requiring complete labelling of all food, drugs and cosmetics that incorporate more than one ingredient, no matter how innocuous the constituents are believed to be. In Canada, drug manufacturers are not even required to share this information with physicians or pharmacists when they introduce a new drug or reformulate a product already being marketed, nor are pharmacists required to disclose the contents of formulations that they prepare in the absence of commercially available products.
ISSN:0008-4409