European Medicine Agency Suspends Loftyl for POAD Patients
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has suspended its authorisation for buflomedil (Loftyl), saying that the risks of severe cardiological and neurological adverse reactions do not outweigh their limited benefits in the treatment of patients with chronic peripheral arterial occlusive disease (PAOD).
Doctors should stop using buflomedil, which is also sold under brand names Hydegine and Sermyon, and consider alternative treatment options, including managing underlying health problems which can increase the risk of PAOD, such as diabetes, high blood pressure and smoking, said the CHMP. In May, the CHMP suspended the oral dose of Loftyl, and today it announced a complete suspension of all forms of the drug. A growing number of people suffer from peripheral arterial disease, and the number is estimated to grow to nine million Europeans and five million US patients by 2020, according to J. Belch's survey (Institute of Cardiovascular Research, Dundee).
Patients using buflomedil-containing medicines should make an appointment with their doctor at a convenient time to discuss their ongoing treatment, advises the medical authority.
Buflomedil, a vasoactive agent, is used to treat the symptoms of PAOD and is sold under the brand name Loftyl by Abbott. PAOD 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.
The review of buflomedil was initiated following the suspension of the marketing authorisation in France by the French regulatory authority in February 2011.
The CHMP considered all available data on the benefits and risks of buflomedil, including the benefit-risk assessment carried out by France, data from clinical studies, post-marketing surveillance and published literature, as well as from poison control centres in the EU.
Following review of these data the Committee concluded that:
* there was a risk of serious neurological and cardiac side effects in patients taking buflomedil under normal conditions of use and that risk minimisation measures such as changes to the packaging of the medicine, recommendations on adjusting the dose for patients with kidney problems and restrictions on the medicines' use in certain patients had not been able to reduce these risks to an acceptable level;
* due to the narrow therapeutic index (i.e. the small difference between buflomedil's therapeutic dose and its toxic dose) 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;
* data in support of the benefit of the medicine for patients were limited and of poor quality.
The Committee was therefore of the opinion that the benefits of buflomedil-containing medicines no longer outweigh their risks, and recommended that marketing of these medicines should be suspended throughout the EU.
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