November 17, 2011 — The European Medicines Agency (EMA) is recommending that buflomedil-containing medicines be suspended from marketing in the European Union (EU) because of concerns about severe neurologic and cardiac toxicity, the agency announced today.
According to the EMA's Committee for Medicinal Products for Human Use, its review of safety and efficacy data found 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)."
"Doctors should stop using buflomedil and consider alternative treatment options, including managing underlying health problems which can increase the risk of PAOD, such as diabetes, high blood pressure as well as smoking," the EMA says in its announcement released today.
The recommendation will be sent to the European Commission for a final decision.
The review of buflomedil followed the suspension of the drug's marketing authorization in France in February 2011. The decision was based on a safety and efficacy review of buflomedil, including a benefit–risk assessment carried out by France, data from clinical studies, postmarketing surveillance, published literature, and data from EU poison control centers.
According to the EMA, a serious risk for neurologic and cardiac adverse events is present even in patients taking buflomedil under normal conditions. Furthermore, efforts to improve the safety, such as labeling amendments and dose adjustments, had not been sufficient to minimize these risks.
"[D]ue to the narrow therapeutic index...there was a significant risk of adverse events, particularly in elderly patients and in patients with certain conditions such as kidney problems, which are common in PAOD," the EMA notes. In addition, data in support of the medicine's benefits were limited and of poor quality, the agency suggests.
In the EU, buflomedil, a vasoactive agent, was indicated for treatment of PAOD symptoms, specifically in patients with stage II PAOD who experience severe pain when walking even relatively short distances.
Buflomedil is not currently approved by the US Food and Drug Administration for use in the United States.
More information on the announcement is available on the EMA Web site.
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Cite this: Buflomedil-Containing Drugs May Be Suspended in EU - Medscape - Nov 17, 2011.