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Mysoline withdrawal: charity warns of health risk to patients

20 August, 2003

The charity Epilepsy Action is calling for the international drugs company AstraZeneca to reconsider its decision to stop production of the anti-epileptic drug Mysoline.

The drug, which is also known as primidone, has been discontinued. By the end of January 2004 Mysoline will be unavailable. An estimated 10,000 people in the UK are currently taking Mysoline. The charity says patients are not being given enough time to withdraw from the drug safely.

Epilepsy Action is urging people who take the drug to see their doctor and gain a specialist appointment as soon as possible so they can transfer to new medication. Recommended guidelines suggest patients withdraw gradually from anti-epileptic medication and Mysoline (a barbiturate) is associated with severe withdrawal problems. According to epilepsy specialists, the drug requires a withdrawal period of between 10 and 18 months. Mysoline stocks are expected to run dry in five months.

Epilepsy Action has drafted a letter for concerned patients to show their doctor, with help from Leeds-based epilepsy specialist Dr Morgan Feely. Dr Feely has highlighted several issues for doctors to consider. He recommends patients receive an urgent referral to a specialist so a complete review of their drug therapy can be undertaken. The letter is available by phoning the Freephone Helpline on 0808 800 5050.

Philip Lee, Chief Executive of Epilepsy Action said:

"We're extremely concerned by this situation. The impact for epilepsy patients is potentially very serious. Withdrawing from this drug too quickly could have devastating consequences for patients - seizure patterns may suddenly change with differences in nature and frequency. As well as affecting people's work and lifestyles this could result in personal injury and potentially loss of life. Many doctors are unaware of the situation and the problem will be compounded by the long wait many patients could face to see their consultant or specialist. The guidelines must change to protect patients who have long-term medical conditions and are reliant on particular forms of medication."

In a statement, AstraZeneca UK announced it was is in advanced discussions with a European company concerning the provision of an alternative supply of primidone:

"The company recognises and apologises for the concerns that have been raised by its earlier announcement and is committed to working with the health care professionals and patient associations to resolve the situation."