Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Atrolak XL Prolonged-release tablets, all strengths (quetiapine fumarate) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Accord Healthcare Ltd has informed MHRA that the Patient Information Leaflet (PIL) for all strengths of Atrolak XL Prolonged-release tablets is missing the side effects identified from post-marketing experience. The affected products are:
- Atrolak XL 50mg Prolonged-release tablets (batch number: 322729, Y06455)
- Atrolak XL 150mg Prolonged-release tablets (batch number: Y04771, Y04788, Y02374)
- Atrolak XL 200mg Prolonged-release tablets (batch number: X17653, Y06710)
- Atrolak XL 300mg Prolonged-release tablets (batch number: Y06909, X21602, X19649, X19866)
- Atrolak XL 400mg Prolonged-release tablets (batch number: X21825, X18765)
The PIL within the packs for the above batches is 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.
Healthcare professionals are advised, 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. Atrolak XL PILs is available from the electronic medicines compendium (emc).
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atrolak-xl-prolonged-release-tablets-all-strengths-quetiapine-fumarate
In Hong Kong, Accord Quetiapine Extended Release Tablets 50mg (HK-64305), Accord Quetiapine Extended Release Tablets 200mg (HK-64304), Accord Quetiapine Extended Release Tablets 300mg (HK-64303) and Accord Quetiapine Extended Release Tablets 400mg (HK-64301) are pharmaceutical products registered by I & C (Hong Kong) Limited (I & C), and are prescription-only medicines. As confirmed with I & C, the affected batches have not been imported into Hong Kong.
Ends/Thursday, Feb 13, 2020
Issued at HKT 17:00
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