PRESS RELEASE ON THE TOXIC EPIDERMAL NECROLYSIS LINKED TO SINOMAL (Sulphadoxine and Pyrimethamine) Tablets 525mg USP
Document No: 1/2023
Date: 15/07/2023
Source:
Pharmacovigilance and Clinical Trials and Information and Communication
Departments
PHARMACY BOARD OF SIERRA
LEONE PRESS RELEASE ON THE TOXIC EPIDERMAL NECROLYSIS LINKED TO SINOMAL
(Sulphadoxine and Pyrimethamine) Tablets 525mg USP (500/25)
The Pharmacy Board of Sierra Leone (PBSL) has received a
suspected adverse drug reaction report of Toxic Epidermal Necrolysis (TEN)
linked to Sulphadoxine and Pyrimethamine 525mg tablets ( 500/25). This case
report includes an adult female that took an OVERDOSE (six tablets) as a single
dose of Sulphadoxine-Pyrimethamine 525mg( 500/25) instead of three tablets
which is the recommended dose as stipulated in the summary of product
characteristic (SmPC) and patient information leaflet (PIL) of the product. The
clinical team at the hospital where the patient is admitted has been providing
all medical care required and the patient is on the way to recovery.As a
result of this PBSL did a preliminary causality assessment and risk-benefit
analysis on this case and concluded that the Toxic epidermal necrolysis is not
as a result of a DRUG QUALITY PROBLEM but probable/likely related to the
medicine due to the OVERDOSE the intrinsic pharmacology of the medicine and
its sulpha chemical moiety which can all contribute to the risk of
hypersensitivity reactions. It is important to note that dermatologic reactions
like TEN are RARE. Therefore all healthcare professionals and the general
public are advised that if sulphadoxine-pyrimethamine is prescribed it is
essential to inquire about allergy to any of the active ingredients or
excipients. Another option should be prescribed if the patient is intolerant to
any of these. Patients should be warned that at the first appearance of a skin
rash they should stop using the medicine and seek medical attention
immediately.
Information and
Communication Department Pharmacy Board of Sierra Leone. Email:
info@pharmacyboard.gov.sl Phone number: 073994830 and 099117117