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UCB's Vimpat recalled over quality defect

UCB's epilepsy treatment Vimpat is to be recalled because of a quality defect, which has led to an uneven distribution of its active ingredient

The European Medicines Agency (EMA) has agreed to a recall of epilepsy treatment Vimpat 15mg/ml syrup, marketed by Belgian pharmaceutical firm UCB, because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup.

The EMA was informed that a flake-like precipitate was observed in the bottles. The precipitate consists of the active substance lacosamide and is not a contamination.

Further analysis showed that the active substance was not evenly distributed in the syrup, which could lead to patients receiving either too much or too little of the active substance. No cases of adverse reactions related to over- or under-dosing have been reported.

UCB is preparing the submission of an application for a10mg/ml syrup for Vimpat to continue to make the medicine available in a liquid formulation. Until this new formulation is authorised in the EU, another 10mg/ml liquid formulation, which is approved in the US, may be made available on a named patient basis for those patients who cannot take Vimpat tablets.

Doctors have been advised to contact their patients to switch them to Vimpat film coated tablets whenever possible. Meanwhile patients have been advised not to stop their medication or change the dose without speaking to their doctor.

The recall will be started on September 15, 2011 to allow sufficient time for patients to be switched to suitable alternatives.

25th July 2011

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