National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRA
Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
This alert is for action by: primary and secondary care, specifically those involved in pharmacy services, including dispensing general practices.
This is a safety critical and complex National Patient Safety Alert. Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards) supported by Chief Pharmacists and the clinical lead for cardiology, as well as leaders in general practice and community pharmacy.
National Patient Safety Alert Reference Number
NatPSA/2022/007/MHRA
PL Number
Mexiletine hydrochloride 50mg Hard Capsules, PL 31644/0027
Mexiletine hydrochloride 100mg Hard Capsules, PL 31644/0028
Mexiletine hydrochloride 200mg Hard Capsules, PL 31644/0029
MDR Number
MDR 109-07/22
Company Name
Clinigen Healthcare Ltd
Product description
Mexiletine hydrochloride 50mg Hard Capsules, PL 31644/0027
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 2111216 | 02/2024 | 84 capsules | 10/02/2022 |
Mexiletine hydrochloride 100mg Hard Capsules , PL 31644/0028
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 2111217 | 04/2024 | 84 capsules | 10/02/2022 |
Mexiletine hydrochloride 200mg Hard Capsules, PL 31644/0029
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 2111218 | 04/2024 | 100 capsules | 10/02/2022 |
Active Pharmaceutical Ingredients: mexiletine hydrochloride
Explanation of identified safety issue
Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
Stability testing identified that some individual capsules on the market may fall outside the individual fill-weight range. This means that there is the potential for some capsules to contain too little active ingredient and for some to contain too much active ingredient. This could result in potential underdosing and overdosing.
Clinigen Healthcare Ltd has confirmed that no alternative batches of Mexiletine hydrochloride 50mg, 100mg or 200mg hard capsules will be available until later in the year, therefore the recall of these batches from patients should only be considered where patients have access to appropriate alternative products. See below for more information on resupplying patients with alternative products.
Patients should be advised not to stop any treatments without consulting their relevant healthcare professional. The risks of suddenly stopping medication for ventricular arrhythmias is higher than the potential risk presented by too much or too little of the active ingredient in the capsule.
Actions required
Actions required to complete by 12 August 2022
The action to recall should be coordinated by the Chief Pharmacist/Superintendent Pharmacist/Responsible Pharmacist and Dispensing GPs in the first instance.
- Stop supplying the impacted batch immediately. Quarantine all remaining stock and return it to your supplier/MAH using your supplier’s approved process.
- Identify and immediately contact all patients who have been dispensed the impacted batch 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 since 10 February 2022 should be contacted.
- If the pharmacist identifies any patients with an impacted batch, they should, in the first instance, contact the patient’s GP and discuss alternative mexiletine treatment of the patient. As this is a specialist use product and patients may require monitoring, other clinicians and healthcare professionals may need to be involved.
- Discuss the risk of cardiac arrhythmias with patients and advise them to seek urgent medical attention if they experience any new or worsening of symptoms of an arrhythmia including palpitations, angina pain, chest discomfort, dizziness and loss of consciousness.
Healthcare professionals may also consider the use of unlicensed medicines where appropriate. See the MHRA recall notice for more information.
Advice for healthcare professionals
Patients should be advised not to stop any treatments without consulting their relevant healthcare professional. The risks of suddenly stopping medication for ventricular arrhythmias is higher than the potential risk presented by continuing to take capsules containing too much or too little of the active ingredient. This product should only be recalled from patients when it has been confirmed that the patient has access to an alternative mexiletine product.
Healthcare professionals should be aware of the following clinical considerations related to the potential risk of either under- or overdosing.
Underdosing
- Underdose could lead to lack of efficacy, which could consequently result in a ventricular arrhythmia
- There needs to be an increased vigilance for symptoms of arrhythmias (palpitation, chest pain, shortness of breath, light-headedness, and syncope) reported by a patient, which may be due to underdosing.
- A patient alert card is supplied with the product in each pack. Advise patients to complete their and their doctor’s name and contact details on the patient alert card and keep it with them at all times, for instance in a wallet or a purse.
- Discuss the risk of cardiac arrhythmias with patients and tell them to seek urgent medical attention if they experience any new or worsening of symptoms of an arrhythmia including palpitations, angina pain, chest discomfort, dizziness and loss of consciousness
- The HCP guide for management of risk of cardiac arrythmia is available here.
Overdosing
- The clinical features include nausea, hypotension, bradycardia, paraesthesia, left bundle branch block, asystole, convulsions, which may be life-threatening and can be fatal.
- Refer to the approved Summary of Product Characteristics (SmPC) for treatment recommendations: Click here to access SmPC via eMC.
Any patients experiencing any of the symptoms listed above should be advised to immediately contact their nearest accident and emergency centre.
Healthcare professionals should note that some patients may have an implantable cardioverter-defibrillator (ICD) fitted and additional monitoring should be considered where appropriate.
Additional monitoring should be considered for all patients due to the potential for under- and/or overdosing to have occurred and as per product literature to monitor electrolytes, full blood counts and liver function tests during treatment and where alternative products may be provided.
Patients who have the impacted batch can be provided with a supplementary letter to explain any potential observations in relation to the issue and underdosing and/or overdosing. See more information in the Download Document section of the MHRA National Patient Safety Alert webpage.
Advice for healthcare professionals on recall and resupply
If the pharmacist identifies any patients with an impacted batch, they should, in the first instance, contact the patient’s GP and discuss alternative mexiletine treatment for the patient. As this is a specialist use product and patients may require monitoring, other clinicians and healthcare professionals may need to be involved.
Healthcare professionals should be aware that other licensed preparations for mexiletine are available. Whilst licensed mexiletine products marketed by Clinigen Healthcare Ltd are out of stock, the only other licensed mexiletine product available is Namuscla 167mg (equivalent to 200mg mexiletine hydrochloride) hard capsules, Summary of Product Characteristics (SmPC): https://www.medicines.org.uk/emc/product/9838/smpc#gref
- Namuscla 167mg hard capsules: Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders and is not indicated for treatment of life-threatening ventricular arrhythmias and supply would be considered “off-label” use.
- Although the MHRA does not recommend “off label” (outside of the licensed indications) use of products, if alternative UK licensed products can meet the patients clinical need, even “off-label”, they should be used instead of an unlicensed product. Licensed products available in the UK have been assessed for quality, safety, and efficacy. It should be understood that the prescribing healthcare professional’s responsibility and potential liability are increased when prescribing off-label.
Healthcare professionals may consider that an unlicensed product (special) should be used as an alternative mexiletine product for patients requiring maintenance doses and any dose titrations in the absence of alternative licensed products.
See Department of Health and Social Care Guidance on ordering and prescribing unlicensed imports:
- Any decision to prescribe an unlicensed medicine must consider the relevant guidance and NHS Trust or local governance procedures. 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
- Prescribing unlicensed medicines, General Medical Council (GMC),
- When prescribing a product that is not licensed in the UK due to a supply issue with the licensed alternative, prescribers must indicate on the FP10 prescription that an unlicensed product is required. This can be done in one of the following two ways:
- Electronic prescriptions – if the required unlicensed product is shown on electronic prescribing systems, GPs should select:
- Mexiletine 50mg capsules (imported)
- Mexiletine 100mg capsules (imported)
- Paper prescriptions – where the unlicensed product is not shown on electronic prescribing systems, GPs should use a paper prescription and annotate with the following wording: “special order”.
- Electronic prescriptions – if the required unlicensed product is shown on electronic prescribing systems, GPs should select:
Patients should be advised to report any side effects to their healthcare professional and via the MHRA’s Yellow Card scheme.
Advice for patients
Patients should not stop taking mexiletine without consulting your relevant healthcare professional. The risks of suddenly stopping medication for ventricular arrhythmias is higher than the potential risk presented by taking capsules containing too much or too little mexiletine.
See further information in the supplementary letter explaining any potential observations relating to underdosing and/or overdosing. See more information in the Download Document section of the MHRA National Patient Safety Alert webpage.
If you feel unwell or experience any of the symptoms mentioned relating to either underdose or overdose, please contact your doctor immediately or visit the nearest accident and emergency centre
Further information
For more information or stock and resupply queries, please contact Quantum Pharmaceutical +44 (0) 1207 279 400 or email enquiries@quantumpharma.co.uk.
For medical information queries, please contact Clinigen Medical Information on +44 (0) 1932 824 026 or email medicalinformation@clinigengroup.com.
For all other enquires place contact Clinigen Healthcare Ltd on +44 (0) 1283 494 340 or email medicineaccess@clinigengroup.com.
Download documents
Updates to this page
Published 4 August 2022Last updated 4 August 2022 + show all updates
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Per correction by Clinigen Healthcare Ltd, an update was made to correct the expiry date for Mexiletine hydrochloride 50mg Hard Capsules (batch 2111216)
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First published.