Epithalon — 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 Epithalon 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 |
|---|---|---|---|---|
| No controlled safety dataset | — | — | — | None of adequate quality exists |
| Telomerase induction | — | — | — | If the proposed telomerase mechanism operated as described, the implications for neoplasia would require careful study; none has been performed |
| 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
- Not established — no marketing authorisation
§4.3Warnings and precautions
- No independent replication of the central mechanistic claim
- A telomerase-activating mechanism, if real, has unstudied neoplasia implications
- No modern safety data
§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.
- Khavinson VK, Kuznik BI, Tarnovskaya SI, Linkova NS. Peptides and CCL11 and HMGB1 as differently expressed age-dependent proinflammatory biomarkers of ageing. Advances in Gerontology 2020;10(1):1–8. doi:10.1134/S2079057020010063
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
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