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EMA recommends suspending buflomedil due to cardiac and neurological adversity.

M2 PHARMA-November 21, 2011-EMA recommends suspending buflomedil due to cardiac and neurological adversity(C)2011 M2 COMMUNICATIONS

21 November 2011 - The European Medicine Agency (EMA) said that its Committee for Medicinal Products for Human Use (CHMP) had recommended the suspension of the marketing authorisations across the EU of all medicines containing buflomedil after establishing that the risks of these drugs in the treatment of peripheral arterial occlusive disease (PAOD) outweigh the benefits.

The recommendation follows a CHMP's review of the safety and effectiveness of buflomedil concluding that the adverse effects, mainly the risks of cardiac and neurological side effects, are bigger than the limited positive impact in PAOD therapy.

Those risks were most prominent in elderly patients and in people with kidney and other health problems, which are common in PAOD. At the same time, data supporting the benefits of buflomedil was limited and of low quality, the CHMP said.

The CHMP launched the review on buflomedil after the French regulator suspended the marketing authorisation in France in February 2011. The CHMP examined all available clinical and post-marketing data on the risks and benefits of buflomedil, including trial results and publications in the EU.

Buflomedil is a vasoactive agent used to treat the PAOD symptoms such as pain and weakness in the legs, which occur due to obstruction in the large arteries. Buflomedil is used to treat people with stage II PAOD, who feel acute pain when walking even short distances.

Physicians should discontinue buflomedil treatment and consider other therapies, including those that address health problems intensifying the risk of PAOD such as high blood pressure, diabetes and smoking.

Buflomedil-containing medicines have been cleared in the EU in the 1970s via national procedures.

Buflomedil is used in the form of tablets, an oral solution or a solution for injection in Austria, Belgium, Cyprus, Germany, France, Greece, Luxembourg, Italy, the Netherlands, Poland, Portugal and Spain under the name Loftyl and other trade names.

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Publication:M2 Pharma
Date:Nov 21, 2011
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