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The CMDh agrees to suspend the marketing authorization of Numeta G13%E because of a risk of hypermagnesaemia.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a medicines regulatory body representing the EU member states, has endorsed the recommendation to suspend the marketing authorization of Numeta G13%E because of a risk of hypermagnesaemia. Numeta G13%E, which is given into a vein to premature babies to provide nutritional support, will remain suspended until a re-formulated preparation is made available.
For Numeta G16%E, used in full-term newborns and children up to 2 years, the CMDh agreed that the benefit-risk balance remains positive. Patients whose blood magnesium levels are elevated or signs of hypermagnesaemia are identified Numeta G16%E should be stopped or the infusion rate reduced.
The review of Numeta G13%E and Numeta G16%E was carried out by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) following several reports of hypermagnesaemia in preterm infants. As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU. The PRAC assessed the available data on the risk of hypermagnesaemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, post-marketing reports and the published literature and considered available treatment guidelines.
The PRAC concluded that the administration of Numeta G13%E could lead to a higher risk of hypermagnesaemia, and noted that this risk is further increased in premature newborns because their kidneys are immature and less able to clear the body of magnesium.
For Numeta G16%E, the PRAC concluded that although the magnesium content may result in a magnesium intake that is slightly higher than suggested in some guidelines, the proposed measures, including updating the product information and a further study, are sufficient to ensure the safe use of this product. In addition, the PRAC recommended a study be carried out to further evaluate blood magnesium levels observed in term newborn infants and children up to two years of age following use of Numeta G16%E.
As the PRAC recommendations were endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.