The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) today recommended suspending the marketing authorization of the intravenous nutrition preparation Numeta G13%E because of a risk for hypermagnesemia in premature infants.
Numeta G13%E, which is given to premature babies to provide nutritional support, should remain suspended until a reformulated preparation is made available, the PRAC said in a statement.
However, the benefit–risk balance remains "positive" for Numeta G16%E used in full-term newborns and children up to age 2 years, the PRAC said, "provided that healthcare professionals monitor their patients' blood magnesium levels before giving the preparation and at appropriate intervals thereafter in accordance with routine clinical practice and the clinical needs of the individual patient."
In patients whose blood magnesium levels are elevated or in whom signs of hypermagnesemia are identified, Numeta G16%E should be stopped or the infusion rate reduced, the committee advised.
Reports of Hypermagnesemia Prompt Review
Hypermagnesemia is a serious condition that can produce symptoms of weakness, nausea and vomiting, breathing difficulties, and hypotension, although it is often difficult to detect.
The PRAC initiated a review of Numeta G13%E after several reports of asymptomatic hypermagnesemia in preterm infants. As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the European Union. Although no reports of hypermagnesemia were received for Numeta G16%E, this product was included in the review.
For their review, the PRAC assessed the available data on the risk for hypermagnesemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, postmarketing reports, and the published literature and considered available treatment guidelines.
The committee also invited stakeholders to submit any relevant information to support the assessment, and the agency's Paediatric Committee was consulted for advice.
On the basis of their assessment, the PRAC concluded that the administration of Numeta G13%E "could lead to a higher risk" for hypermagnesemia. In addition, the PRAC noted that this risk is further increased in premature newborns because their kidneys are immature and are less able to clear the body of magnesium. The PRAC also noted the difficulty in identifying symptoms of hypermagnesemia in premature newborns, which means hypermagnesemia may not be detected until it causes serious complications.
While Numeta G13%E is suspended, healthcare professionals should use alternative nutrition solutions, the PRAC said.
Action on Numeta G16%E
For Numeta G16%E, the PRAC concluded that the magnesium content "may result in a magnesium intake that is slightly higher than suggested in some guidelines."
The committee recommends that the product information be revised accordingly and healthcare professionals be informed in writing of the potential risk for hypermagnesemia, which is increased in patients with impaired kidney function and in patients whose mothers were receiving supplemental magnesium before delivery, and of the measures to be taken to minimize this risk.
In addition, the PRAC recommends a study be carried out to further evaluate blood magnesium levels observed in term newborn infants and children up to age 2 years after use of Numeta G16%E.
These proposed measures "are sufficient to ensure the safe use of this product," the committee concluded.
These PRAC recommendations will be considered by the Coordination Group for Mutual Recognition and Decentralised Procedures–Human at its meeting to be held September 16 to 18, 2013.
Numeta G13%E and Numeta G16%E have been authorized since 2011 in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, and the United Kingdom.
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Cite this: PRAC Wants Numeta G13%E Off the Market - Medscape - Sep 06, 2013.