Iodinated Contrast Media: Risk of Severe Cutaneous Adverse Reactions (SCAR)

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Overview

Iodinated contrast media (ICM) is used in medical X-ray imaging to distinguish physiologically normal and abnormal features1. Different ICMs vary greatly in their physical and chemical characteristics, indication and toxicity2. They are used intravenously at most of the time, but can also be administered via intraarterially, intrathecally and intraabdominally3.

 

Background of Safety Issue

In Malaysia, there are currently seven (7) types of ICM available, namely iohexol, iomeprol, amidotrizoic acid/diatrizoate, ioxitalamate, iopamidol, ioversol and iobitridol4. At present, a total of 19 products containing ICM are registered with the Drug Control Authority (DCA).

The Pharmaceuticals and Medical Devices Agency (PMDA), Japan, had directed the product registration holders of iohexol and iomeprol to update their package insert with the risk of acute generalised exanthematous pustulosis (AGEP)5,6. This decision was made based on opinions of expert advisors following reports of AGEP received by the PMDA and literature review.

Based on literature review and search in global ADR data, other skin adverse reactions such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported following ICM use. Following this, NPRA has required product information of ICM products to be updated with the risk of SCAR.

 

Adverse Drug Reaction Reports

The NPRA has received a total of 486 reports with 853 adverse events related to iodinated contrast media. The most reported adverse event were pruritus (158), followed by rash (105) and urticaria (99). To date, no case of severe cutaneous adverse reactions following the use of ICM has been reported to the NPRA.

 

 Advice for Healthcare Professionals

  • Counsel patient on the signs and symptoms of initial skin reaction. Advise patient to return to the hospital immediately if the signs and symptoms start to appear.
  • Please report all adverse events suspected to be related to the concomitant use of iodinated contrast media to the NPRA.

 

A directive [Ruj. Kami: (24) dlm. BPFK/PPP/07/25] has been issued by NPRA for updates to the local product packaging insert and consumer medication information leaflet (Risalah Maklumat Ubat untuk Pengguna) related to this safety issue. Please refer to the directive for more information.

 

References:

  1. Goergen, Stacy (2017). Inside Radiology: Iodine-containing contrast medium.
  2. Pasternak J.J. and Williamson E.E. (2012). Clinical Pharmacology, Uses, and Adverse Reactions of Iodinated Contrast Agents: A Primer for the Non-radiologist. Mayo Clin Proc. 2012 Apr; 87(4): 390–402.
  3. Jagdish Singh et al. (2008). Iodinated Contrast Media and Their Adverse Reactions. Journal of Nuclear Medicine Technology; 36(2):69-74.
  4. The NPRA QUEST 3+ Database [Accessed: May 2018]
  5. Pharmaceuticals and Medical Devices Agency (2018). PMDA Safety Information No. 351, March 2018.
  6. Pharmaceutical and Medical Devices Agency (2018). Summary of Investigation Results – Iomeprol and iohexol.
  7. The Malaysian Adverse Drug Reaction database, NPRA [Accessed: May 2018]

 

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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