Epilepsy Action has been told that both the anti-epileptic drugs (AEDs)
Zarontin capsules and Emeside capsules (branded versions of the drug
ethosuximide) are to be discontinued from the UK market.
capsules are being withdrawn with immediate effect and Zarontin
capsules will be available until October 2006. Zarontin syrup and
Emeside syrup will not be affected and will remain on the market.
the manufacturer of Zarontin, have explained their reason for stopping
the production of this drug: they say they are having difficulties in
meeting quality standards and although they have tried different ways
to meet these standards, they have been unsuccessful. For this reason,
they say they have no alternative but to stop manufacturing the
the manufacturer of Emeside, have said that, due to circumstances
beyond their control, Emeside capsules have had to be discontinued with
immediate effect. No stocks remain.
Epilepsy Action has expressed extreme concern at the news of the sudden and immediate discontinuation of the Emeside capsules.
The charity says that expert clinical opinion (supported by National Institute for Health and Clinical Excellence
guidance) advises that when patients are having their anti-epileptic
drug withdrawn it should be done slowly, over at least two to three
months. Epilepsy Action says this is likely to be impossible for people
taking Emeside capsules, given that clinicians and patients have had no
notice of the discontinuation of the capsules.
issued a statement to health professionals informing them that Zarontin
capsules will be discontinued and giving advice on how to manage the
necessary change of AED for patients. The advice indicated that Emeside
was the only alternative capsule AED containing ethosuximide. However,
given the news that Emeside capsules have been discontinued, no
alternative capsule is currently available and the advice issued by
Pfizer is no longer applicable. Zarontin syrup 250mg/5ml, which
contains ethosuximide, will continue to be available but its
formulation is different to the capsule formulation, so Epilepsy Action
is urging people to contact their doctor to check dosages.
Philip Lee, Epilepsy Action's chief executive, comments:
are extremely concerned that the sudden discontinuation of Emeside
capsules will compromise the health of anyone taking capsule versions
of ethosuximide. We are strongly advising that people prescribed the
Emeside capsules should urgently contact their epilepsy specialist to
discuss alternative medication. People taking Zarontin capsules should
also seek an appointment with their specialist for advice. Epilepsy
Action is calling on the government to ensure supplies of Emeside
continue to be available for a longer period to allow a managed
transfer to alternative medication."
Action said it is important than an epilepsy specialist carefully
monitors any changes as the formulation for Zarontin and Emeside syrups
are different to the capsule versions and dosages may need to be
The Department of Health
is investigating the availability and quality of unlicensed
ethosuximide capsules from a variety of international sources and will
provide information to health care professionals as soon as possible.
The Department of Health states that there might be a suitable
alternative for patients who need an ongoing supply of ethosuximide,
and for whom the liquid formulation is not suitable.