Deferiprone: Risk of neurological disorders in children

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Overview

Deferiprone is an iron-chelator that removes excess iron from the body in patients with thalassemia major when treatment with other iron chelators is inadequate or contraindicated.

 

Background of Safety Issue

NPRA has received information from Health Canada regarding a safety alert on the potential risk of neurological disorders in children receiving deferiprone at recommended doses.

Previously, the package insert of deferiprone has already documented this risk occurring in children who received deferiprone at 2.5 times more than the recommended dose. However, a safety review was initiated by Health Canada when two published cases of neurological disorders including difficulty walking or difficulty with the coordination of movement were observed in children treated with deferiprone at recommended doses. Health Canada has concluded that these neurological adverse events may occur with deferiprone even at recommended doses. Following this, product manufacturers of deferiprone are required to update the package insert with this information1.

Upon further investigation, it was noted that the package insert of deferiprone in Europe was approved by the European Medicine Agency (EMA) to be updated with safety information on the risk of neurological disorders in children receiving standard doses of deferiprone. Among the neurological disorders observed with the standard dose are hypotonia, instability, inability to walk, and hypertonia with inability of limb movement. These neurological disorders were found to gradually subside with discontinuation of deferiprone2.

 

Adverse Drug Reaction Reports

NPRA has received 351 ADR reports with 721 adverse events suspected to be related to deferiprone. To date, no report related to neurological disorders such as difficulty in walking or difficulty in coordination of movement has been reported3.

 

Advice for Healthcare Professionals

  • Monitor for any signs and symptoms of neurological disorders in patients taking deferiprone at any dose.
  • Please report any adverse events suspected to be related to deferiprone to NPRA.

 

References:

  1. Health Canada (2019). Summary Safety Review - Ferriprox (deferiprone) – Assessing the potential risk of brain and nervous system (neurological) disorders in children.
  2. European Medicine Agency (2018). Product information - Ferriprox [Accessed: May 2019]
  3. The Malaysian Adverse Drug Reaction database, NPRA [Accessed: April 2019]

 

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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  • Last Modified: Khamis 12 September 2019, 14:20:55.
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