Overview

Beta-lactam antibiotics are among the most commonly prescribed drugs, grouped together based upon a shared structural feature, the beta-lactam ring. Beta-lactam antibiotics include the penicillins, cephalosporins, carbapenems and monobactam antibiotics.

Background

Health Canada has reviewed the potential risk of Severe Cutaneous Adverse Reactions (SCARs) with beta-lactam antibiotics after receiving information from a manufacturer that included reports of SCARs with the use of amoxicillin-clavulanic acid in Canada. It was found that the product information on the risk of SCARs for various beta-lactam antibiotics was inconsistent, and this prompted Health Canada to conduct the review for all the antibiotics in this group. 

Based on the review of all available information, it was established that there is a link between the use of beta-lactam antibiotics and the risk of SCARs. Following this, Health Canada will be working with the manufacturers to update the product information of beta-lactam antibiotics with the information related to SCARs¹.

Local Scenario

In Malaysia, the information regarding SCARs in product information of various beta-lactam antibiotics was also found to be inconsistent and inadequate. There were also local reports on SCARs with use of beta-lactam antibiotics, as follows.

Adverse Drug Reaction Reports

Since year 2000, the NPRA has received a total of 833 ADR reports related to SCARs for beta-lactam antibiotics².

Advice for Healthcare Professionals

1. Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams.
2. Before initiating therapy with any beta-lactam antibiotics, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other beta-lactam agents.
3. If an allergic reaction occurs, the beta-lactam antibiotic must be discontinued immediately and appropriate alternative therapy instituted.
4. Advise patients to stop the antibiotic and seek medical assistance immediately if they experience any of the following symptoms: skin reddening, blisters, rash, fever, sore throat or eye irritation.
5. Please report all adverse events suspected to be related to the use of beta-lactam antibiotics to NPRA.

A directive [Ruj. Kami: (2) dlm. BPFK/PPP/07/25 Jld. 3] 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. Health Canada (2018). Summary Safety Review - Beta-lactam Antibiotics - Assessing the Potential Risk of Severe Skin Side Effects.
2. The Malaysian Adverse Drug Reactions database, NPRA [Accessed: December 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.