AEMPS Briefing Note on buflomedil (Lofton ®): suspension of marketing.
Publication Date: May 20, 2011
Category: DRUGS FOR HUMAN USE, SAFETY.
Reference: MUH (FV) 06/2011
• The English Agency for Medicines and Health Products announced the suspension of marketing of buflomedil (Lofton ®) from 15 July 2011.
• No new treatments should be initiated Lofton ® and proceed to review the treatment of patients currently using this medication.
• No need to interrupt patients treatment until they come to consult your doctor.
The English Agency for Medicines and Medical Devices (Competent Authority) informed healthcare professionals about the suspension of marketing next buflomedil (Lofton ®).
Buflomedil is a peripheral vasodilator, approved in Spain in 1980 in the form of tablets and oral solution droplets. Its licensed indication is the symptomatic treatment of intermittent claudication in peripheral arterial occlusive disease stage II (see data sheet Lofton ®).
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) comprising representatives of all European national agencies, has recommended the suspension of marketing in Europe buflomedil medicines containing as active ingredient. This recommendation has been adopted after the reassessment of the benefit-risk (arbitration).
The arbitration proceedings began after the February 2011 suspension marketed in France. This suspension was due to the occurrence of serious adverse neurological and cardiac, in some cases fatal. These adverse reactions were related to accidental or intentional overdose of medication, even after the country adopted measures to reduce the risk of overdose with the drug.
For this review, the CHMP considered all available data on the benefits and risks of buflomedil, including the assessment carried out in France, data clinical trials, notifications of suspected adverse reactions and information from the literature.
The CHMP has concluded that the measures in France have not prevented the occurrence of overdoses and buflomedil has limited benefit for patients in terms of improving walking distance. Therefore, considered that expected benefits may not outweigh the potential risks.
The Commission shall publish the relevant decision to the conditions of the suspension of marketing.
Regarding the situation in Spain, the Competent Authority reports the following:
• marketing suspension Lofton ® tablets and oral solution drops Spain will become effective on 15 July, the date from which you can not prescribe or dispense the drug.
• To date, no new treatments should be initiated Lofton ® and proceed to review the treatment of patients currently using this medicine, taking into account the current recommendations for treating this disease is based primarily on smoking cessation, exercise and establishment of adequate antiplatelet therapy.
• It is imperative that patients discontinue the treatment until you come to the consulting your doctor.
Available the press release and document questions and answers on its website EMA (www.ema.europa.eu).
Finally recalls the importance of reporting all suspected adverse reactions to the Centre for Pharmacovigilance Autonomy.
Date updated: May 20, 2011
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