Oseltamivir: Risk of haemorrhages

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Overview

Oseltamivir is indicated for the treatment and prophylaxis of influenza and is available in the form of capsules and oral suspension.1

 

Background

The National Pharmaceutical Regulatory Agency (NPRA) has received information from Health Canada on the potential risk of haemorrhages in general with the use of oseltamivir.2

Health Canada had started a safety review following an update  by the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, on an update of safety information for oseltamivir products with new information on the risk of haemorrhages in general. In the safety review, Health Canada had reviewed information from the Canadian Vigilance dan international database as well as published literature on the potential link between the use of oseltamivir with the risk of haemorrhages in general. Based on the review, the information was found to be inadequate. However, it was concluded that there may be a link on the use of oseltamivir and the risk of lower gastrointestinal bleeding. As the Canadian product safety information for oseltamivir has already included information on the risk of gastrointestinal bleeding, there was no further product information update required.

 

Adverse Drug Reaction (ADR) Reports

NPRA has received a total of 175 ADR reports with 295 adverse events suspected to be related to oseltamivir-containing products.3 There were reports of bleeding adverse events associated with oseltamivir use, such as epistaxis (1) and petechiae (1) but no event of gastrointestinal bleeding. Both adverse events appeared to have occurred in small children aged 9 months old and 4 years old.

 

Advice for Healthcare Professionals

  • Be alert on the risk of haemorrhages when prescribing oseltamivir to patients.
  • Advise patients and their caretakers to be practice caution whilst on oseltamivir therapy, and to inform healthcare professionals if any bleeding symptoms including epistaxis and haematemesis occurred.
  • Please report all suspected adverse events associated with oseltamivir to the NPRA.

 

References:

  1. National Pharmaceutical Regulatory Agency.  QUEST3+ Product Search [Internet]. 2021 [Cited 2021 May 5] Available from: https://www.npra.gov.my
  2. Health Canada. Summary Safety Review: Tamiflu (oseltamivir) and generics - Assessing the Potential Risk of Haemorrhages [Internet]. 2021 January 8 [Cited 2021 January 11]. Available from: https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00255.
  3. National Pharmaceutical Regulatory Agency. The Malaysian National ADR Database [Internet]. 2021 [Cited 2021 May 5]. Available from: https://www.npra.gov.my

 

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 (Jalan Profesor Diraja Ungku Aziz), 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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