Specialist initiation (S1)

BRIVARACETAM

  • SMC restrictionRestricted to adjunctive treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with epilepsy. Treatment should be initiated by physicians who have appropriate experience in the treatment of epilepsy.
  • MHRA Category 3.

Specialist initiation (S1)

CARBAMAZEPINE

  • Hepatic enzyme inducing agent and reduces the effectiveness of hormonal contraceptives.
  • MHRA Category 1.

ESLICARBAZEPINE

  • Hepatic enzyme inducing agent and reduces the effectiveness of hormonal contraceptives.
  • SMC restrictionas adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation, with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs.
  • MHRA Category 2.

OXCARBAZEPINE

  • Hepatic enzyme inducing agent and reduces the effectiveness of hormonal contraceptives.
  • MHRA Category 2.

Specialist initiation (S1)

CENOBAMATE

  • SMC restriction: Restricted to specialist initiation in patients with drug-resistant epilepsy as a second-line adjunctive anti-seizure medicine, after the failure of the first adjunctive anti-seizure medicine.

Specialist initiation (S1)

ETHOSUXIMIDE

  • MHRA Category 3.

Specialist initiation (S1)

GABAPENTIN

  • MHRA Category 3.

Specialist initiation (S1)

LACOSAMIDE

  • SMC restriction: adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with refractory epilepsy.
  • MHRA Category 3.

Specialist initiation (S1)

LAMOTRIGINE

  • Combined oral contraceptives can affect the concentration of lamotrigine.
  • Lamotrigine use has been associated with skin reactions and blood dyscrasias.
  • MHRA Category 2.

Specialist initiation (S1)

LEVETIRACETAM

  • MHRA Category 3.

Specialist initiation (S1)

PERAMPANEL

  • SMC restriction: for use as a second-line adjunctive treatment in patients with refractory partial onset epilepsy.
  • MHRA Category 2.

Specialist initiation (S1)

PHENOBARBITAL

  • Hepatic enzyme inducing agent and reduces the effectiveness of hormonal contraceptives.
  • MHRA Category 1.

Specialist initiation (S1)

PHENYTOIN

  • Hepatic enzyme inducing agent and reduces the effectiveness of hormonal contraceptives.
  • MHRA Category 1.

Specialist initiation (S1)

PRIMIDONE

  • Hepatic enzyme inducing agent and reduces the effectiveness of hormonal contraceptives.
  • MHRA Category 1.

Specialist initiation (S1)

RUFINAMIDE

  • Hepatic enzyme inducer and reduces the effectiveness of hormonal contraceptives.
  • SMC restrictionas adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), in patients who have failed treatment with, or are intolerant to, other antiepileptic drugs.
  • MHRA Category 2.

Specialist initiation (S1)

TOPIRAMATE

  • MHRA Category 2.

IMPORTANT NEW RESTRICTIONS MHRA update (June 2024): introduction of new safety measures, including a Pregnancy Prevention Programme.

  • Topiramate should not be used in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled. Clinicians are reminded of the need to use highly effective contraception throughout treatment and for at least four weeks after the last dose of topiramate.
  • Topiramate is an enzyme-inducer, meaning it may alter the effectiveness of different hormonal contraceptives. Guidance from Faculty of Family Planning and Sexual Health provides information on potential drug interactions with hormonal contraceptives and what this means for topiramate.  

MHRA Resources: Patient Guide for Migraine and Epilepsy, Guide for Healthcare Professionals for Migraine and Epilepsy, Risk Awareness Form for Migraine and Epilepsy, Patient Card. For information on when these resources are to be utilised/provided please see Drug Safety Update June 2024.

Source: Drug Safety Update June 2024: Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme

Specialist initiation (S1)

SODIUM VALPROATE

MHRA VALPROATE AND DEVELOPMENTAL DISORDERS ALERT

IMPORTANT NEW RESTRICTIONS: MHRA DRUG SAFETY UPDATES JANUARY 2024, SEPTEMBER 2024 and FEBRUARY 2025.

Additional safety measures include a requirement for a review by two specialists when initiating valproate for MALES and FEMALES under the age of 55 and for existing FEMALE patients already prescribed valproate under the age of 55. A review by two specialists is not required for existing MALE patients already taking valproate.

Valproate must not be prescribed to women/girls of childbearing potential unless enrolled in pregnancy prevention programme (PPP).

Inform male patients (of any age) who may father children of the possible increased risk of neurodevelopmental disorders in children conceived around the time of valproate use and the recommendation to use effective contraception (condoms, plus contraception used by the female sexual partner) during valproate treatment and for at least 3 months after stopping valproate.

Source: MHRA Drug Safety Update Jan 2024: New safety and educational materials to support regulatory measures in men and women under 55 years of age, Sep 2024: Valproate use in men: as a precaution, men and their partners should use effective contraception, and Feb 2025: Valproate: review by two specialists is required for initiating valproate but not for male patients already taking valproate

MHRA ResourcesMHRA information pagePatient GuidePatient cardPatient Information LeafletHealthcare Professional GuideAnnual Risk Acknowledgement Form for female patients, Risk Acknowledgement Form for male patients starting valproate, Advice for male patients on valproate to use contraception, Visual risk communication diagram to be used by a healthcare professional when counselling on the risks, and infographics which clarify in which situations review by two specialists may be required: for female patients under 55 years old, for male patients under 55 years old and for male and female patients 55 years and older

Specialist initiation (S1)

VIGABATRIN

  • MHRA Category 3.

Specialist initiation (S1)

ZONISAMIDE

  • SMC restriction: as adjunctive therapy in adult patients with partial seizures, with or without secondary generalisation.
  • Zonisamide should be initiated only by physicians who have appropriate experience in the treatment of epilepsy and should be used principally in patients who have not benefited from treatment with an older anti-convulsant drug, or for whom these drugs are unsuitable because of contraindications, interaction or poor tolerance.
  • MHRA Category 2.

Specialist initiation (S1)

CLONAZEPAM

  • MHRA Category 2.

CLOBAZAM

  • Licensed for adjunctive therapy only.
  • MHRA Category 2.

To indicate the category of a formulary medicine, updated sections adopt the following key:

Preferred list (P): First-line formulary choices.

Total list (T): Alternative choices when preferred list options not effective/not tolerated, or not indicated.

Specialist initiation (S1): Specialist initiation, or on the advice of a Consultant or Specialist Practitioner in this therapeutic area. Continuation in primary care is acceptable.

Specialist use only (S2): Supply via hospital, Homecare Service or a hospital based prescription (HBP) for dispensing by community pharmacy. Not prescribed in primary care setting.

Editorial Information

Author(s): NHSL.

Version: Please refer to the introduction section for an explanation of the review dates above.

Approved By: ADTC