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European regulator wants Abbott's Loftyl suspended

EMA says risk of serious cardiological and neurological side effects of peripheral arterial occlusive disease treatment too great

The European Medicines Agency (EMA) has recommended the suspension of Abbott's Loftyl (buflomedil) due to the risk of serious cardiological and neurological side effects.

The regulator said that any potential benefits of buflomedil, which is used to treat peripheral arterial occlusive disease, did not outweigh its risks.

A review by the EMA's Committee for Medicinal Products for Human Use (CHMP) concluded efforts to minimise these risks, including restricting its use in certain patients, had not been able to cut down buflomedil's potential for harm.

Data supporting the benefits of the agent, which has been authorised in the EU since the 1970s, was also said to be 'limited and of poor quality'.

The EMA's review of buflomedil was initiated following France's decision to suspend Loftyl's marketing authorisation in February, 2011.

Doctors are now advised to stop using buflomedil in favour of other treatment options, while patients on the drug should speak to their healthcare professional.

The CHMP's recommendation to suspend medicines containing buflomedil, including Abbott's Loftyl, will be discussed by the European Commission which will make a final decision on the drug's marketing authorisation.

18th November 2011

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