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Concern over ethosuximide capsule discontinuation

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PJ Online homeThe Pharmaceutical Journal
Vol 275 No 7373 p539
29 October 2005

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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Epilepsy Action highlights the fact that antiepileptic medication should be withdrawn gradually over at least two to three months.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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Citation: The Pharmaceutical JournalURI: 20015941

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