Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Jul;91(7):387-92.
doi: 10.1016/j.earlhumdev.2015.04.008. Epub 2015 May 15.

Safety of octreotide in hospitalized infants

Daniela Testoni  1 , Christoph P Hornik  2 , Megan L Neely  3 , Qinghong Yang  4 , Ann W McMahon  5 , Reese H Clark  6 , P Brian Smith  7 ; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee
Collaborators, Affiliations

Safety of octreotide in hospitalized infants

Daniela Testoni et al. Early Hum Dev. 2015 Jul.

Abstract

Background: Octreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile of octreotide in hospitalized infants has not been described; we sought to fill this information gap.

Methods: We identified all infants exposed to at least 1 dose of octreotide from a cohort of 887,855 infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012. We collected laboratory and clinical information while infants were exposed to octreotide and described the frequency of baseline diagnoses, laboratory abnormalities, and clinical adverse events (AEs).

Results: A total of 428 infants received 490 courses of octreotide. The diagnoses most commonly associated with octreotide use were chylothorax (50%), pleural effusion (32%), and hypoglycemia (22%). The most common laboratory AEs that occurred during exposure to octreotide were thrombocytopenia (47/1000 infant-days), hyperkalemia (21/1000 infant-days), and leukocytosis (20/1000 infant-days). Hyperglycemia occurred in 1/1000 infant-days and hypoglycemia in 3/1000 infant-days. Hypotension requiring pressors (12%) was the most common clinical AE that occurred during exposure to octreotide. Necrotizing enterocolitis was observed in 9/490 (2%) courses, and death occurred in 11 (3%) infants during octreotide administration.

Conclusion: Relatively few AEs occurred during off-label use of octreotide in this cohort of infants. Additional studies are needed to further evaluate the safety, dosing, and efficacy of this medication in infants.

Keywords: Drug toxicity; Infant; Octreotide; Safety.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Octreotide use over time.
Fig. 2
Fig. 2
Octreotide use by site.
See this image and copyright information in PMC

References

    1. Bauer W, Briner U, Doepfner W, Haller R, Huguenin R, Marbach P, et al. SMS 201-995: a very potent and selective octapeptide analogue of somatostatin with prolonged action. Life Sci. 1982;31(11):1133–40. - PubMed
    1. Foo NH, Hwang YS, Lin CC, Tsai WH. Congenital chylothorax in a late preterm infant and successful treatment with octreotide. Pediatr Neonatol. 2011;52(5):297–301. - PubMed
    1. Tyden G, Samnegard H, Thulin L, Muhrbeck O, Efendic S. Circulatory effects of somatostatin in anesthetized man. Acta Chir Scand. 1979;145(7):443–6. - PubMed
    1. U.S. Food and Drug Administration Web site. [Accessed October 22, 2013];Sandostatin (octreotide acetate) injection. [pdf]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf.
    1. D'Amico G, Pietrosi G, Tarantino I, Pagliaro L. Emergency sclerotherapy versus vasoactive drugs for variceal bleeding in cirrhosis: a Cochrane meta-analysis. Gastroenterology. 2003;124(5):1277–91. - PubMed

Publication types