GovWire

DMRC Reference Number

DMRC-30746702

Company name

Desitin Pharma UK Ltd

Product name

Lamotrigine Desitin 10mg/ml Oral Suspension, PL 14040/0040

SNOMED Code

42751111000001102

Active Pharmaceutical Ingredient: Lamotrigine

Brief description of the problem

Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testing. Desitin Pharma UK Ltd believe that this is a homogeneity issue with the batches manufactured. This issue means that there is the potential for some doses to have too little active ingredient (lamotrigine) in them and some doses to contain too much active ingredient. This could result in potential underdosing or overdosing. No such confirmed reports have been received to date. The root cause of this issue is under investigation, but based on the potential for a homogeneity issue, the product is being recalled as a precautionary measure.

Advice for healthcare professionals

Stop supplying the impacted batch immediately. Quarantine all remaining stock and return it to your supplier/MAH using your suppliers approved process.

Patients should be advised not to stop their medication as this may cause seizures to start again or happen more often or last longer than before.

1. Pharmacists should identify and immediately contact all patients who have been dispensed the impacted batches and ask them to confirm if they have remaining stock within their possession. If batch traceability information is not available, all patients dispensed this product from 07 May 2024 should be contacted. Patients and carers should be reminded that suddenly stopping an epilepsy medicine may cause seizures to start again or happen more often or last longer than before.

If the pharmacist identifies any patients with an impacted product, they should, in the first instance, contact the patients GP or prescriber and discuss alternative lamotrigine treatment for the patient. As patients may require monitoring, other clinicians and healthcare professionals may need to be involved.

2. Prescribers, clinicians, and other healthcare professionals involved in the prescribing/monitoring of patients who are using lamotrigine oral suspension should contact their patients and/or carers directly to ensure that their treatment is reviewed, and a suitable alternative product is prescribed.

Desitin Pharma UK Ltd has confirmed that Lamotrigine Desitin 10mg/ml Oral Suspension (PL 14040/0040) was first distributed on 07 May 2024 and therefore prior to this, this specific product was not available in the UK. Desitin UK Pharma Ltd have also confirmed that 282 packs have been sold from wholesalers to pharmacies directly and the remaining stock (circa 4800 units) will not be distributed.

Healthcare professionals should be aware that there are no other licensed lamotrigine oral suspension/solutions available, and patients will require substitution with other licensed formulations including tablets, dispersible tablets, and/or an unlicensed product (specials). See details in Further Information section.

Lamotrigine has been designated as a Category 2 Antiepileptic drug (AED). See further information in the MHRA Drug Safety Update.

Advice for patients

The MHRA have been made aware of a potential issue with Lamotrigine Desitin 10mg/ml Oral Suspension. The issue identified by the manufacturer means that there is the potential for some doses to have too little lamotrigine in them and some doses to contain too much active ingredient. This could result in potential underdosing or overdosing. These batches are being recalled as a precaution; we are not aware of any confirmed cases of patient harm.

Your GP, specialist, pharmacist, or other healthcare professional will contact you to make sure you get a new prescription for an alternative product. Once you have a replacement, you should return your Lamotrigine Desitin 10mg/ml Oral Suspension to any pharmacy as part of the recall. You can contact your healthcare professional directly if you are worried but you should keep taking your medicine as advised until you get an alternative.

Never stop taking medicines such as lamotrigine without medical advice, especially if they are being used for epilepsy. Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before.

Patients who experience adverse reactions, have a sudden worsening of their clinical condition, or have any questions about medication used by you or someone you care for, should seek medical attention. If you have any concerns about your or your childs health, consult with your healthcare professional. Continue to take your medicine as prescribed.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via theMHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact medinfo@desitin.co.uk. For stock control enquiries please contact alison.wilton@desitin.co.uk.

Any decision to prescribe an unlicensed medicine must consider the relevant guidance and NHS Trust or local governance procedures. Unlicensed imports do not undergo any central quality assessment or suitability evaluation. Therefore, any import must be locally assessed in line with local unlicensed medicines processes.

Please see the links below for further information:

• The supply of unlicensed medicinal products, Medicines and Healthcare products Regulatory Agency (MHRA)
• Professional Guidance for the Procurement and Supply of Specials, Royal Pharmaceutical Society
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