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Brief Summary

GUIDELINE TITLE

Newer drugs for epilepsy in adults.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Newer drugs for epilepsy in adults. London (UK): National Institute for Clinical Excellence (NICE); 2004 Mar. 36 p. (Technology appraisal; no. 76).

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • December 12, 2007, Carbamazepine: The U.S. Food and Drug Administration (FDA) has provided recommendations for screening that should be performed on specific patient populations before starting treatment with carbamazepine.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • The newer antiepileptic drugs gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate and vigabatrin, within their licensed indications, are recommended for the management of epilepsy in people who have not benefited from treatment with the older antiepileptic drugs such as carbamazepine or sodium valproate, or for whom the older antiepileptic drugs are unsuitable because:
    • there are contraindications to the drugs
    • they could interact with other drugs the person is taking (notably oral contraceptives)
    • they are already known to be poorly tolerated by the individual
    • the person is a woman of childbearing potential (see below).
  • It is recommended that people should be treated with a single antiepileptic drug (monotherapy) wherever possible. If the initial treatment is unsuccessful, then monotherapy using another drug can be tried. Caution is needed during the changeover period.
  • It is recommended that combination therapy (adjunctive or 'add-on' therapy) should only be considered when attempts at monotherapy with antiepileptic drugs (see above) have not resulted in seizure freedom. If trials of combination therapy do not bring about worthwhile benefits, treatment should revert to the regimen (monotherapy or combination therapy) that has proved most acceptable to the patient, in terms of providing the best balance between effectiveness in reducing seizure frequency and tolerability of side effects.
  • In women of childbearing potential, the possibility of interaction with oral contraceptives and the risk of the drugs causing harm to an unborn child should be discussed and an assessment made as to the risks and benefits of treatment with individual drugs. There are currently few data upon which to base a definitive assessment of the risks to the unborn child associated with the newer drugs. Specific caution is advised in the use of sodium valproate because of the risk of harm to the unborn child.
  • It is recommended that all people having a first seizure should be seen as soon as possible by a specialist in the management of the epilepsies to ensure precise and early diagnosis and initiation of therapy as appropriate to their needs.
  • Treatment should be reviewed at regular intervals to ensure that people with epilepsy are not maintained for long periods on treatment that is ineffective or poorly tolerated and that concordance with prescribed medication is maintained.
  • The recommendations on choice of treatment and the importance of regular monitoring of effectiveness and tolerability are the same for specific groups such as older people and those with learning disabilities as for the general population.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

Only randomised controlled trials and systematic reviews were included in the review of clinical effectiveness, and in addition non-randomised experimental studies and observational studies were included in the review of serious, rare and long-term adverse events.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Newer drugs for epilepsy in adults. London (UK): National Institute for Clinical Excellence (NICE); 2004 Mar. 36 p. (Technology appraisal; no. 76).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 Mar

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Dr A E Ades, MRC Senior Scientist, MRC Health Services Research Collaboration, University of Bristol; Dr Tom Aslan, General Practitioner, Stockwell, London; Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester; Professor Rosamund Bryar, Professor of Community and Primary Care Nursing, St Bartholomew School of Nursing and Midwifery; Dr Richard Cookson, Senior Lecturer, Health Economics, School of Health Policy and Practice, University of East Anglia, Norwich; Professor Terry Feest, Clinical Director & Consultant Nephrologist, Richard Bright Renal Unit, & Chair of UK Renal Registry, Bristol; Dr John Geddes, Consultant Psychiatrist, University Department of Psychiatrists, Oxford; Ms Bethan George, Interface Liaison Pharmacist, Tower Hamlets PCT and Royal London Hospital, Whitechapel; Mr John Goulston, Director of Finance, Barts and the London NHS Trust; Dr Terry John, General Practitioner, The Firs, London; Mr Muntzer Mughal, Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust, Chorley; Judith Paget, Chief Executive, Caerphilly Local Health Board, Torfaen; Mr James Partridge, Lay Representative; Chief Executive, Changing Faces, London; Mrs Kathryn Roberts, Nurse Practitioner, Hyde, Cheshire; Professor Andrew Stevens (Vice-Chair) Professor of Public Health, University of Birmingham; Dr Cathryn Thomas, General Practitioner, & Senior Lecturer, Department of Primary Care & General Practice, University of Birmingham; Dr Norman Vetter Reader, Department of Epidemiology, Statistics and Public Health, College of Medicine, University of Wales, Cardiff; Dr David Winfield, Consultant Haematologist, Royal Hallamshire Hospital, Sheffield

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N0453. 11 Strand, London, WC2N 5HR.

Additionally, Audit Criteria can be found in Appendix C of the original guideline document.

PATIENT RESOURCES

The following is available:

  • Newer drugs for epilepsy in adults. Understanding NICE guidance - information for adults with epilepsy, their families and carers, and the public. London (UK): National Institute for Health and Clinical Excellence (NICE); 2004 Mar. 10 p. (Technology appraisal 76).

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the Department of Health Publications Order Line 0870 1555 455. ref: N0454. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

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