MHRA Class 4 Drug Alert Atrolak (Quetiapine) XL (Accord) Caution in use

MHRA Class 4 Drug Alert Atrolak (Quetiapine) XL (Accord) Caution in use

February 12, 2020

Drug alert number: EL (20)A/06

Date issued: 12 February 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Atrolak (Quetiapine) prolonged release tablets (Accord)

Accord Healthcare Ltd has informed MHRA that the Patient Information Leaflet (PIL) within the packs for the batches detailed below are missing the side effects identified from post-marketing experience that are documented in Section 4. (Possible Side Effects) of the PIL:

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph
nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). Stop using Atrolak
XL [quetiapine] if you develop these symptoms and contact your doctor or seek medical attention immediately.

It is important that any patients who notice the symptoms seek immediate medical advice.

Atrolak XL 50mg prolonged release tablets PL 20075/0213

Batch Number Expiry Date Pack Size First Distributed
322729 05/2021 60 19 December 2019
Y06455 10/2021 60 03 September 2019

Atrolak XL 150mg prolonged release tablets PL 20075/0446

Batch Number Expiry Date Pack Size First Distributed
Y04771 10/2021 60 06 November 2019
Y04788 10/2021 60 27 September 2019
Y02374 05/2021 60 07 August 2019

Atrolak XL 200mg prolonged release tablets PL 20075/0214

Batch Number Expiry Date Pack Size First Distributed
X17653 02/2021 60 24 November 2019
Y06710 08/2021 60 18 November 2019

Atrolak XL 300mg prolonged release tablets PL 20075/0215

Batch Number Expiry Date Pack Size First Distributed
Y06909 09/2021 60 04 October 2019
X21602 05/2021 60 07 April 2019
X19649 03/2021 60 03 July 2019
X19866 03/2021 60 11 June 2019

Atrolak XL 400mg prolonged release tablets PL 20075/0216

Batch Number Expiry Date Pack Size First Distributed
X21825 05/2021 60 10 October 2019
X18765 03/2021 60 05 July 2019

Advice for contractors 

When dispensing this product, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of any missing information. The current PILs includes the special warning and precautions and should be issued when this product is dispensed. Click here for Atrolak XL PILs available from the electronic medicines compendium (emc).

For more information or medical information queries, please contact: Accord Medical Information Department on 01271 385257.

Full details of the drug alert can be viewed here.

 

 



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