Journal of Clinical Nutrition & Dietetics

Safety and Usage of an Amino Acid-based Formula for Infants: Results from a Post Market Surveillance Study

Safety and Usage of an Amino Acid-based Formula for Infants: Results from a Post Market Surveillance Study.

Background: The primary objective was to assess the frequency and nature of Adverse Events (AE) in infants fed a hypoallergenic amino acid-based infant formula. Secondary objectives were to describe the demographic and clinical characteristics of participants.

Methods: This prospective, multicentre, post-market surveillance program with Alfamino® Infant formula (HAA) was conducted during 2017-2018. Infants <12 months old were enrolled if the use of HAA was planned per their Health Care Provider’s (HCP) recommendation, or if the infant was already consuming HAA at enrolment. Infants were followed by their HCP for routine care for four months.

Findings: 144 infants were enrolled, 69% (n=100) with a diagnosis of Cow’s Milk Protein Allergy (CMPA). Six (4%) of the 144 subjects reported a Serious Adverse Event (SAE), though for all the causal relationship to the formula was reported as “Unrelated” or “Unlikely”. In total, 156 AE were reported in 58 subjects (40%). Of those, the relationship to the formula was deemed to be “Unrelated” in 122 (78%), “Unlikely” in 14 (9%), “Probable” in 17 (11%), “Definitely” in 1 (1%), and “Unknown” in 2 (1%). Emesis and constipation were the most frequently reported events with a “Probable” association. There were no reports of anaphylaxis during the study. Eighty present (n=91) of caregivers were satisfied with the formula.

Conclusion: In this study, use of an amino acid infant formula in infants with CMPA, severe CMPA, and malabsorptive conditions does not present with safety concerns and shows a high degree of caregiver satisfaction with the formula.

Author(s):

Pamela Cekola, Aimee Henrikson , Heidi Reichert, Sarah S Cohen , Maureen B Huhmann, and Krysmaru Araujo Torres

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