Concern over ethosuximide capsule discontinuation
Extreme concern at the sudden and immediate withdrawal of epilepsy drug Emeside (ethosuximide) has been expressed by Epilepsy
Action.
Laboratories for Applied Biology (LAB), the product licence holder for
Emeside, announced this month (PJ, 15 October, p477) that Emeside
capsules 250mg have been discontinued and no stock remains; Emeside syrup will
be available for the time being.
The situation is complicated by the fact that Pfizer, the only other
manufacturer that holds a licence to produce and distribute ethosuximide
capsules, plans to discontinue Zarontin (ethosuximide) capsules 250mg
in October 2006; Zarontin syrup will remain available.
Epilepsy Action highlights the fact that antiepileptic medication should
be withdrawn gradually over at least two to three months. Philip Lee,
chief executive of Epilepsy Action, commented: “We 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 that supplies
of Emeside are available for longer to allow a managed transfer to alternative
medication. A spokeswoman for the Department of Health told The Journal: “The
department has been in discussion with both companies, as well as Epilepsy
Action, to help ensure that health care professionals and patients are
aware of these discontinuations. We are also investigating the availability
and quality of unlicensed ethosuximide capsules from a variety of international
sources, which might be a suitable alternative for patients who need
an ongoing supply of ethosuximide, and for whom the liquid formulation
is not suitable.”
A spokesman at LAB commented: “We were advised by the manufacturers
that they were no longer able to make [Emeside capsules] in the UK. We
considered moving production to France, but this would have meant having
[Emeside capsules] off the market for a year while capsules from the
new plant were validated.”
He explained that the apparently sudden withdrawal of Emeside capsules
is linked to the planned withdrawal of Zarontin capsules. “Problems
with the production of Zarontin led to a run on Emeside, depleting our
stocks much more rapidly than had been anticipated. The subsequent announcement
that Zarontin would be discontinued caused another run which cleared
our stocks completely.”
In a press release, Kate Lloyd, medical director at Pfizer, said: “Pfizer
has decided to discontinue Zarontin capsules from the UK market because
of persistent failure to meet manufacturing quality standards and none
of the corrective measures adopted have been able to resolve this problem.
Pfizer … hopes that the extensive advance notice of the discontinuation
will allow all those affected to be identified, contacted and appropriately
advised and treated.” |
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