B. Braun: HES should be kept on the market
B. Braun is convinced that HES can be used effectively and safely in the authorized indications.
Melsungen (Germany). B. Braun Melsungen AG stated today that medicinal products containing hydroxyethyl starch (HES) should be kept available for the treatment of patients. HES solutions are used as volume replacement solution in patients suffering acute blood loss due to a severe injury or surgical procedures when crystalloids alone are not considered sufficient. B. Braun is convinced that HES can be used effectively and safely in the authorized indications.
The Coordination Group for Mutual Recognition and Decentralised Procedures - human (CMDh), the committee in charge for the European Medicines Agency of the EU Commission, has recommended suspending the market authorization of HES in the EU through a majority vote. The final decision now lies with the EU Commission. The main reason for the CMDh vote was that HES products were frequently infused outside the authorized uses or despite contraindications for certain patient groups, e.g. in patients who are critically ill or those with sepsis A use outside the approved labelling information is called “off-label”. In these cases measures are required to avoid off-label-use, but cannot be a reason for suspending the authorization in indications with positive benefit-risk-ratio. The company is going to commence legal action against a decision, especially since an expert commission set up by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) had voted by a large majority to continue to allow the use. The commission suggested to wait for the results of two current clinical studies on perioperative use and use in trauma patients to get more evidence about the positive risk/benefit balance. The expert commission came to the conclusion that HES has its place in the treatment of patients and should continue to be available.