Epilepsy Action announces Mysoline news, UK

Main Category: Public Health
Article Date: 25 Jun 2004 - 17:00 PDT

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After months of anxious waiting, people with epilepsy taking the anti-epileptic drug Mysoline have been informed that AstraZeneca, who make the drug, will transfer the licence for Mysoline (primidone) to Acorus Therapeutics Limited. The announcement comes as a result of many months of campaigning by Epilepsy Action, the UK's largest member-led epilepsy organisation and its members and supporters, to prevent the drug being withdrawn.

The uncertainty over Mysoline began in June last year, when AstraZeneca announced they would be discontinuing supplies of the drug at the end of 2003. Epilepsy Action, along with health professionals, expressed serious concern about the devastating effect that such a short withdrawal time could have on the 10,000 people taking Mysoline. AstraZeneca then announced that supplies would be extended until the end of 2006. There has been no firm guarantee of a long-term solution until today's announcement.

Some patients who are prescribed Mysoline are still taking it because previous attempts to wean them off the drug led to severe difficulties. Frances Bolton from Exeter has been taking the drug for many years: "This is brilliant news. It's been a worry for such a long time. Previous attempts to withdraw me from Mysoline have resulted in serious side affects including hallucinations and severe depression."

Philip Lee, Epilepsy Action's Chief Executive said: "The news will bring relief to thousands of people with epilepsy who depend on Mysoline. Many of our members have had a long and traumatic year waiting for a firm guarantee about the future of this drug. We hope that this news will end some of the immediate worry and anxiety but we will continue to monitor the situation.

We hope that in future drug companies will consult with patients before taking this kind of decision. People's health should come first."

For further information and advice, contact Epilepsy Action's freephone helpline 0808 800 5050 or look at Epilepsy Action's website:
http://www.epilepsy.org.uk.

=== NOTES TO EDITORS ===

Epilepsy Action is the country's leading member-led epilepsy organisation. The charity provides information and advice to over 365,000 every year via its freephone helpline, website, national branch network, accredited volunteer scheme, and range of literature and videos. For further information, please contact Jenny Goldthorpe, PR Assistant or Barbara Pinder, Press Officer on 0113 210 8800 or press@epilepsy.co.uk

Information about Epilepsy:

- Epilepsy is the tendency to have recurrent seizures.

- There are over 40 different types of epilepsy and a person can have more than one type.

- Epilepsy can affect anyone, from any walk of life and at any age.

- 1 in 133 people in the UK have epilepsy - 440,000.

Information about Mysoline:

- Mysoline (brand name) or Primidone (generic name) was first licensed in 1952. It is used to treat all forms of epilepsy except absence seizures.

- Discontinuation of Mysoline was announced by manufacturers AstraZeneca in June 2003, due to low demand for the product. The company notified the Department of Health, purchasing pharmacists and pharmaceutical press.

AstraZeneca has also written to Neurologists, PCT pharmacists and GP pharmacists to alert them to the withdrawal of the drug.

- Epilepsy Specialist withdrawal rates for Mysoline are based on dose reductions of 10 per cent every four to eight weeks. This means withdrawal from Mysoline should take place over a period of 10 to 18 months.

- Mysoline is a barbiturate - there are dependency issues for patients. Consequences of rapid withdrawal include the possibility of breakthrough seizures and/or an increase or change in seizure activity/severity.

Rapid withdrawal from anti-epileptic medication threatens quality of life, driving and employment, and increases the risk of epilepsy-related death.

Current guidelines on discontinuation of drugs:

The Department of Health Best Practice Guidelines suggest drug companies give between three and six months notice of the cessation of drug production. If there is no alternative available for the drug then up to 12 months notice should be given.

http://www.dh.gov.uk/PolicyAndGuidance/MedicinesPharmacyAndIndustry/DiscontinuedMedicines/fs/en

The guidelines do not take into account the severe withdrawal problems associated with some medication; the sensitivity/dependency issues that often arise with drugs used for treating long-term medical conditions, like epilepsy; or the long wait for consultant appointments many patients face.

Epilepsy Action believes an urgent review should be undertaken to protect patients who have long-term conditions against the sudden withdrawal of their medication. The charity continues to work for a review of the current regulations.

This press release is also available in Adobe Acrobat PDF and Microsoft Word formats at:
http://www.epilepsy.org.uk/press/releases.html

If you would like to contact Epilepsy Action regarding any matters which may concern the media please contact our Press Officer, Barbara Pinder:
Phone: +44 (0)113 210 8800
Fax: +44 (0)113 391 0300
Email: press@epilepsy.org.uk