EMA Recommends Suspension of Oral Buflomedil-Containing Medicines

The decision was taken because serious and sometimes fatal neurological and cardiac side effects, mainly related to accidental or intentional overdose, continued to occur.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that the supply of oral buflomedil-containing medicines be suspended in all European Union (EU) Member States where it is currently authorised. This is an interim recommendation pending the finalisation of the continuing review of the benefits and risks of buflomedil solution for injection. The CHMP will adopt an opinion at the end of the full review.

Buflomedil, a vasoactive agent, is used to treat the symptoms of peripheral arterial occlusive disease (PAOD). This is a condition where the body’s large arteries become obstructed causing symptoms such as pain and weakness, particularly in the legs. Buflomedil is used in patients with stage II PAOD, who experience severe pain when walking even relatively short distances.