Asbestos fibers in parenteral medication

Our plain-English summary of Asbestos fibers in parenteral medication, by J. Addison, K. Browne, J.M. Davis, et al (Regulatory Toxicology and Pharmacology, 1993).

The study

• Authors: J. Addison, K. Browne, J.M. Davis, U.F. Gruber
• Journal: Regulatory Toxicology and Pharmacology
• Published: 1993;18(3):371-80
• Type of article: Review
• Cited by: 2 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

The adequacy of current regulations for the control of particulate matter in injectable medicines has been brought into question by a recent television program which reported that asbestos fibers had been found in a number of such preparations. The fibers were identified as chrysotile, which occurs very widely as a secondary mineral in rocks, and is almost ubiquitous among minerals derived from natural erosion. Fibers are found in almost all drinking water and air samples unrelated to any contamination of fiber resulting from industrial exploitation. Because of this, even extreme laboratory precautions may fail to eliminate every fine fiber. A normal person living in an urban environment inhales about 10(5) asbestos fibers daily and ingests 10(10). There is evidence that a small proportion of these fibers regularly enters the circulation, and some fibers may be excreted in the urine. Elimination also occurs because retained chrysotile fibers fragment and disappear relatively quickly from human tissues, probably through macrophage action. Fiber length and dose are also important in disease causation. Established evidence on fiber length, durability, and quantitative exposure required for disease production does not indicate that the fibers reported to have been found in parenteral preparations constitute any hazard.

In plain English

This paper was a review prompted by a Südwestfunk television program of January 18, 1993, which, citing transmission electron microscopy work at the Fraunhofer Institute in Hannover, claimed that two antibiotic preparations and a vitamin K injection contained chrysotile: some fibers longer than 5 micrometres in the vitamin preparation, 9000 fibers all shorter than 2.5 micrometres in one antibiotic, and so many particles in another that fibers on the filter could not be counted. The authors reviewed published evidence that chrysotile is almost ubiquitous in air and water, so even extreme laboratory precautions may fail to exclude every fiber; that fibers have been recovered from virtually every organ, mostly short chrysotile (<4 micrometres); that chrysotile splits into thin filaments and fragments in tissues; that fibers are excreted in urine; and that lifetime feeding studies showed absence of ill effects at very high doses. The authors concluded that established evidence on fiber length, durability and the quantitative exposure required for disease production did not indicate that the fibers reported in parenteral preparations constitute any hazard.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Review/commentary on published evidence, written in response to a television report; no new experiment or patient series
• Who was studied: No study subjects of its own; the paper drew on published human and animal studies of asbestos deposition, clearance and disease
• Exposure: Chrysotile fibers reported in injectable medicines (two antibiotic preparations, a vitamin K injection), plus background environmental chrysotile in air and water
• Main results:
  • The television claim, as reported by the authors, was that 9000 fibers, all shorter than 2.5 micrometres, were found in one of the antibiotic preparations
  • The authors stated that, because chrysotile is so widespread in the environment, laboratory precautions cannot be relied on to exclude every fiber
  • From the literature reviewed: intravenously administered fibers were rapidly removed from the blood and deposited in tissues within minutes
  • From the literature reviewed: fibers have been recovered from virtually every organ, with quantity usually related to exposure and the majority being short chrysotile (<4 micrometres)
  • From the literature reviewed: chrysotile bundles split into individual thin filaments within days of deposition in tissues and eventually fragment
  • From the literature reviewed (animal data, Wagner 1974): chrysotile lung content levelled off after 3 months with no further increase
  • From the literature reviewed: lymph nodes act as filters, 9 micrometres being the maximum fiber length found in postnodal lymph
  • From the literature reviewed: asbestos fibers are routinely excreted in the urine of both occupationally exposed workers and normal control populations
  • From the literature reviewed: lifetime feeding studies repeatedly showed an absence of ill effects even at very high doses
• The authors' conclusion: The authors concluded that established evidence on fiber length, durability and the quantitative exposure required for disease production does not indicate that the fibers reported in parenteral preparations constitute any hazard
• Limitations the authors state:
  • The authors noted that no data are available on the kinetics of circulating fibers in the blood or on the efficiency of the kidney in removing them

Topics

Medical terms in this study, explained in our Lexicon: Chrysotile, Macrophage, Fiber Length, Causation.

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