Clinical evidence and review register
Evidence source check: 2026-11-06. The entries below are proposed corrections for clinician review. Neither a source-check date nor publication records approval. Patients should not independently change or stop medicines; urgent reactions need immediate assessment.
Corrections, privacy and safety contact
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Proposed shared statements
lw first line focal
Levetiracetam is an appropriate option for many people. UK NICE NG217 includes lamotrigine or levetiracetam as first-line monotherapy options for focal seizures. Individual selection requires assessment of seizure type, comorbidities, adverse effects, interactions, reproductive considerations and patient preferences.
Scope: For Clinicians; Place in Therapy; Alternatives; search/print/PDF derivatives
Jurisdiction: UK guidance; Australian product information checked separately
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
Decision awaiting clinician: Approve how to describe Australian preferred options alongside NICE and SANAD II; do not imply NICE is Australian licensing guidance.
lw classification and urgency
Clarify diagnosis and seizure classification wherever possible and revisit uncertainty. This is not an instruction to delay time-critical treatment. Emergency seizure treatment may be needed before a full epilepsy classification is established, followed by reassessment of the ongoing indication and medicine choice.
Scope: For Clinicians; Reflex Prescribing; glossary
Jurisdiction: UK emergency guideline used as supporting source; Australian clinician/local emergency protocol governs treatment
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
Decision awaiting clinician: Approve patient wording and any local emergency protocol link. Do not publish doses from this summary.
sanad ii focal
SANAD II enrolled 990 people aged 5 years or older with newly diagnosed focal epilepsy. Its primary endpoint was time to 12-month seizure remission. Levetiracetam did not meet non-inferiority to lamotrigine in the intention-to-treat analysis: HR 1.18, 97.5% CI 0.95–1.47; non-inferiority margin 1.329. The reported HR compares lamotrigine with levetiracetam; HR above 1 favours lamotrigine for remission. The per-protocol competing-risk analysis favoured lamotrigine: HR 1.32, 97.5% CI 1.05–1.66. These are time-to-event relative effects, not absolute remission probabilities.
Scope: All SANAD II claims
Jurisdiction: UK multicentre trial; not Australian prescribing regulation
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
sanad ii treatment failure
Time to treatment failure was a separate secondary endpoint. For lamotrigine versus levetiracetam its HR was 0.60 (95% CI 0.46–0.77), favouring lamotrigine. Do not substitute this endpoint or HR for time to 12-month remission.
Scope: SANAD II tables and snippets
Jurisdiction: UK trial
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
historical seizure freedom
In Kwan and Brodie's 2000 cohort, 222 of 470 previously untreated patients (47%) became seizure-free for at least one year on their first drug; 67 of 470 (14%) did so on a second or third drug, and 12 of 470 (3%) with two-drug treatment. These are cohort proportions, not the conditional success chance of every next medicine. The reported 11% subsequent seizure freedom applied to patients whose first treatment failed for lack of efficacy. The study did not establish that a 'correct' first drug prevents later drug resistance.
Scope: Place in Therapy; IRE; glossary; charts
Jurisdiction: Historical single-centre Scottish cohort
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
drug resistance framework
Persistent events require review of diagnosis, seizure classification, whether treatment trials were informative, medicine selection and use, access or adherence barriers, interactions and other explanations. This is a discussion framework, not evidence that an individual clinician or drug caused permanent refractory epilepsy. ILAE drug-resistant epilepsy requires failure of adequate trials of two tolerated, appropriately chosen and used antiseizure medication schedules to achieve sustained seizure freedom.
Scope: IRE; false pharmacoresistance; glossary
Jurisdiction: International ILAE definition
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
Decision awaiting clinician: Approve renaming prominent IRE headings to 'Apparent treatment resistance: reasons to reassess' or retaining the term with an explicit framework-only qualification.
esett
ESETT studied benzodiazepine-refractory convulsive status epilepticus in patients aged 2 years or older. Its endpoint combined absence of clinically evident seizures and improved consciousness at 60 minutes, without additional antiseizure medicine. Success occurred in 47% with levetiracetam, 45% with fosphenytoin and 46% with valproate. The trial stopped for futility of finding superiority or inferiority. It did not establish equivalence or universal interchangeability, and it does not answer long-term maintenance-treatment questions.
Scope: Emergency treatment; Place in Therapy; news/research
Jurisdiction: US emergency trial
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
behaviour and depression
Levetiracetam can cause irritability, aggression, other behavioural changes, depression or psychotic symptoms; monitor mood and behaviour and seek prompt advice for concerning changes. Do not quote a universal 13% depression risk. Josephson 2019 found 165/1173 (14.1%) had a psychiatric symptom or therapeutic code within two years after a first levetiracetam prescription in a UK records-based cohort; this was not depression alone and cannot establish drug causation. US labelling reports 13% versus 6% for a composite of nonpsychotic behavioural symptoms in adult clinical studies, not depression alone.
Scope: For Clinicians; Side Effects; Patient Leaflet; comparison/glossary
Jurisdiction: Australian qualitative warning; UK cohort and US label percentages are separate contexts
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
- Josephson CB et al. JAMA Neurol. 2019;76:440–446. ↗
- 5.1 Behavioural abnormalities; US label ↗
- 4.4; Australian PI ↗
Decision awaiting clinician: Recommend qualitative patient-facing wording; approve any retained numeric estimate with adjacent population, comparator, denominator and study-design caveats.
cognitive effects
Avoid 'no cognitive impairment'. Drowsiness, forgetfulness and difficulty concentrating can occur; effects vary between people.
Scope: Patient Leaflet; Side Effects; comparison
Jurisdiction: Australian Keppra tablets/oral-solution CMI
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
pregnancy
Avoid 'safe in pregnancy'. Levetiracetam is an option with comparatively reassuring pregnancy evidence when clinically appropriate; individual benefits, uncertainties and seizure-control risks need specialist discussion. Do not stop or change treatment independently. The 2024 US AAN/AES/SMFM guideline includes levetiracetam among options to minimise major congenital-malformation risk when suitable for the syndrome and patient.
Scope: Place in Therapy; Patient Leaflet; pregnancy comparisons
Jurisdiction: Australian PI; US guideline separately identified
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
Decision awaiting clinician: Approve local counselling and monitoring wording. Avoid importing US folate doses as Australian requirements; Australian PI and US guideline differ.
rash and urgent action
For Keppra, seek a doctor straight away or attend an emergency department for serious allergic symptoms or flu-like illness with widespread rash and/or fever; call 000 for a medical emergency. Routine advice against independent sudden stopping must not delay urgent assessment. Different medicines have different instructions: Australian Lamictal PI requires prompt evaluation of any rash and immediate withdrawal unless clearly not drug-related. Do not copy one medicine's rash/withdrawal instruction to all medicines.
Scope: All medicine safety HTML, PDFs and print
Jurisdiction: Australia; medicine-specific CMI/PI
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
Decision awaiting clinician: Approve patient-facing next-dose/urgent-contact wording for each medicine. Keep emergency advice distinct from routine tapering advice.
australian keppra indications
Australian Keppra oral PI: focal-onset seizures initially as add-on from age 4; newly diagnosed focal-onset monotherapy from age 16; juvenile-myoclonic-epilepsy myoclonic seizures as add-on from age 12; idiopathic-generalised-epilepsy primary generalised tonic-clonic seizures as add-on from age 4. These indications must not be generalised to other countries, brands or formulations.
Scope: Medicine monograph; clinician tables; PI/CMI labels
Jurisdiction: Australia; Keppra film-coated tablets and 100 mg/mL oral solution only
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
first aid au
Follow the individual seizure management plan. Protect from injury; do not put objects in the mouth or restrain unless essential to avoid injury. Once the seizure stops, if unresponsive and breathing normally, use the recovery position. If unresponsive and not breathing normally, call 000 and follow the dispatcher and ANZCOR basic life support instructions. Call an ambulance if the person may be pregnant or the event is inconsistent with the management plan.
Scope: First aid; SOS; emergency plans
Jurisdiction: Australia / New Zealand ANZCOR; 000 action Australia only
Reviewer / actual review: unassigned / not recorded; approval pending.
Next trigger: clinician approval, source change or correction.
Decision awaiting clinician: Clinical first-aid review and approval still required. Source check is not approval.