Teduglutide — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Teduglutide as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Abdominal pain | 38.0 | 23.0 | +15.0 | STEPS |
| Nausea | 25.0 | 20.0 | +5.0 | STEPS |
| Injection-site reaction | 21.0 | 5.0 | +16.0 | STEPS |
| Stomal complication (in patients with a stoma) | 42.0 | 3.0 | +39.0 | STEPS |
| Fluid overload | 12.0 | 7.0 | +5.0 | STEPS |
| Colorectal polyp | — | — | — | Colonoscopy required before initiation and periodically thereafter |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Active gastrointestinal malignancy
- Active malignancy outside the gastrointestinal tract within the preceding five years in some labelling
§4.3Warnings and precautions
- Neoplastic growth — colonoscopy before initiation, at one year, and at least every five years thereafter
- Intestinal obstruction
- Biliary and pancreatic disease — laboratory surveillance advised
- Fluid overload with cardiac decompensation
- Increased absorption of concomitant oral medicines requiring narrow therapeutic monitoring
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641
- Müller TD, Finan B, Bloom SR, D’Alessio D, Drucker DJ, Flatt PR, Fritsche A, Gribble F, Grill HJ, Habener JF, Holst JJ, Langhans W, Meier JJ, Nauck MA, Perez-Tilve D, Pocai A, Reimann F, Sandoval DA, Schwartz TW, Seeley RJ. Glucagon-like peptide 1 (GLP-1). Molecular Metabolism 2019;30:72–130. doi:10.1016/j.molmet.2019.09.010 · PMID 31767182
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