Colloidal silica-induced hypersensitivity: myth or reality

Int J Clin Pharm. 2016 Feb;38(1):7-9. doi: 10.1007/s11096-015-0225-x. Epub 2015 Nov 27.

Abstract

Background: Many excipients have been reported to induce drug hypersensitivity (e.g. colouring additives, preservatives). Colloidal silica has never been reported to induce drug hypersensitivity reactions.

Case report: We report herein a 40-year-old patient who developed a skin eruption 2 days after Voltarene(®) (diclofenac) intake, confirmed by a positive patch test. Investigation of cross reactivity, assessed by patch testing to other non steroidal anti-inflammatory drugs, have showed a positive reaction only to piroxicam (Piroxen(®)), ketoprofen (Oki(®)) and indometacin (Indocid(®)). A hypersensivity to colloidal silica, a common excipient, was suspected. A patch test to this compound was performed showing a positive reaction.

Conclusion: Colloidal silica, a compound widely used in drug manufacturing, could be another culprit excipient in inducing skin hypersensitivity reactions.

Keywords: Colloidal silica; Drug hypersensitivity reaction; Patch test.

Publication types

  • Case Reports

MeSH terms

  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Anti-Inflammatory Agents, Non-Steroidal / chemistry
  • Diclofenac / adverse effects*
  • Diclofenac / chemistry
  • Drug Compounding
  • Drug Eruptions / diagnosis
  • Drug Eruptions / etiology*
  • Excipients / adverse effects*
  • Excipients / chemistry
  • Humans
  • Male
  • Patch Tests
  • Predictive Value of Tests
  • Risk Factors
  • Silicon Dioxide / adverse effects*
  • Silicon Dioxide / chemistry
  • Skin / drug effects*
  • Skin / pathology

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Excipients
  • Diclofenac
  • Silicon Dioxide