View Alert


Originator: MHRA Drug Alerts

 
From: Himal Makwana

Issue date: 12-Feb-2020 11:00:19

Action by recipients:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health

Information to recipients:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • GP Practices
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, ACCORD HEALTHCARE LTD, ATROLAK XL PROLONGED RELEASE TABLETS, ALL STRENGTHS, (QUETIAPINE FUMARATE - SEE ALERT FOR MORE INFORMATION)

Broadcast content:
Accord Healthcare Ltd has informed the MHRA that the Patient Information Leaflet (PIL) for specific batches of Atrolak XL Prolonged Release Tablets (quetiapine fumartate) are missing the side effects identified from post-marketing experience that are documented in Section 4. (Possible Side Effects) relating to Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome.

Healthcare professionals are asked to ensure that patients are aware of the missing information and the current PIL should be included when dispensing the the batches listed in this alert, (https://www.medicines.org.uk/emc/search?q=Atrolak&filters=attributes%5bpil%5d&offset=1&limit=50&orderBy=product&refreshFilters=true).

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.


Additional information: NHS England Regional Offices: please cascade this alert to community pharmacy.
GP Practices: Please note this alert is relevant to Dispensing GP Practices only.


Alert reference: EL (20)A/06

Attachments:
Cascade to:
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency