04 Jun 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Co-ordination group for Mutual Recognition and Decentralized Procedures - Human (CMDh), a medicines regulatory body representing the European Union (EU), has endorsed the recommendation by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), that permission to market oral medicines containing almitrine should be withdrawn across the European Union (EU).
As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by the EU member states where oral almitrine is authorized, according to an agreed timetable which should be completed by 25 July 2013.
Almitrine is a stimulant of the part of the brain responsible for the breathing reflex. In the EU, it is authorized in France, Poland and Portugal, to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood). These conditions pose a particular problem in patients with lung conditions known as chronic obstructive pulmonary disease (COPD), where the airways and air sacs inside the lungs become damaged or blocked.
The safety review of oral almitrine was requested by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), because of concerns about side effects and a view that the available evidence did not support the use of the medicine in the current management of COPD.
The PRAC concluded that there is a clear association between oral almitrine treatment and potentially serious and long-lasting peripheral neuropathy (damage to the nerves in the hands and feet) and significant weight loss that further weakens patients. The PRAC noted that cases continue to be reported even after additional precautions on the use of the medicines were put in place. Furthermore, oral almitrine is no longer included as a recommended therapy in international treatment guidelines for the management of COPD.
The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorizations should be withdrawn throughout the EU.
In the EU, it is authorized in France, Poland and Portugal as 50-mg tablets (Vectarion, Armanor) for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood).