EMA Recommends Suspension of Buflomedil-containing Medicines

According to the EMA, the benefits of buflomedil-containing medicines do no longer outweigh their risks, and marketing of these medicines should be suspended throughout the EU.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded a review of the safety and efficacy of buflomedil, saying that the risks of these medicines, particularly the risks of severe cardiological and neurological adverse reactions, are greater than their limited benefits in the treatment of patients with chronic peripheral arterial occlusive disease (PAOD).

Buflomedil, a vasoactive agent, is used to treat the symptoms of peripheral arterial occlusive disease (PAOD). Buflomedil is used in patients with stage II PAOD, who experience severe pain when walking even relatively short distances.

The Committee recommended that the marketing authorisations of all buflomedil-containing medicines be suspended in all European Union Member States where