Levetiracetam Neuraxpharm granules for oral solution in sachet defect notice over a labelling error

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/40). Quoted as issued.

Summary

Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information.

The risk

DMRC reference number DMRC- 40741691 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare professionals are advised that the current Patient Information Leaflet (PIL) for Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet does not contain all the information included in the corresponding reference product information.

1. Healthcare professionals, including GPs, independent prescribers and specialist prescribers, involved in prescribing Levetiracetam should continue to prescribe and dispense Levetiracetam Neuraxpharm in accordance with the approved product information and manage patients according to their individual clinical circumstances.

Healthcare Professionals should be informed:

that the approved indication includes use in infants from one month of age.

of the information relating to very rare SCN8A mutation-associated early-onset epilepsy.

that there is evidence suggesting a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS).

that obsessive-compulsive disorder (OCD) is a recognised very rare adverse reaction.

that multiorgan hypersensitivity reactions is a recognised rare adverse reaction.

The following text has been included from other brands of levetiracetam products (reference product) that contain the correct information and indicate what sections will be updated in due course:

SmPC section 4.4 and PIL section 2: Lack of efficacy or seizure worsening has for example been reported in patients with epilepsy associated with sodium voltage-gated channel alpha subunit 8 (SCN8A) mutations.

SmPC section 4.8 and PIL section 4: Evidence also suggests a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS).

SmPC section 4.8 and PIL section 4: Very rare cases of development of obsessive-compulsive disorders (OCD) in patients with underlying history of OCD or psychiatric disorders have been observed in post-marketing surveillance.

Advice for patients

Patients should continue to take medicines from these batches as prescribed by your healthcare professional. The quality of the granules for oral solution in sachets is not affected by this issue.

Patients should contact the relevant healthcare professional if:

Patients should seek medical advice if they experience any unexpected change or worsening in their condition, including an increase in the frequency or severity of seizures.

Very rarely, changes in thoughts or behaviour, including new or worsening obsessive thoughts or repetitive behaviours, may occur. Patients should speak to their healthcare professional if they experience such symptoms.

Patients should seek urgent medical attention if they develop any combination of high temperature, marked muscle stiffness, confusion, reduced consciousness, or changes in blood pressure or heart rate, as these may be signs of a serious reaction known as neuroleptic malignant syndrome.

Patients should also seek urgent medical attention if they develop any combination of fever, skin rash, swelling of the face, swollen lymph nodes, or other unexplained symptoms affecting different parts of the body, particularly within 2 to 8 weeks of starting treatment, as these may indicate a serious hypersensitivity reaction known as DRESS.

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

Open the MHRA notice