Is Afamelanotide safe?
Trials, two-year cohort and label data
In the phase 3 trials, most adverse events were mild. Serious events were judged unrelated to the drug. The most common effects are implant-site reactions, nausea, headache, fatigue and skin darkening. The darkening is the intended effect. In the two-year Dutch cohort, side effects were minor and went away on their own. 56
The US label warns of serious hypersensitivity reactions, including anaphylaxis. It advises full-body skin exams. The drug darkens moles and freckles. That could make melanoma harder to spot. No one knows if MC1R stimulation changes melanoma risk over decades. The trials were too short and too small to tell. Unregulated 'melanotan' products sold online for tanning are different compounds. Nobody oversees how they are made. 28
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More on Afamelanotide
Citations
- FDA: Scenesse (afamelanotide) prescribing information, 2019 accessdata.fda.gov
- McGill Office for Science and Society: the 'Barbie drug' mcgill.ca
- EMA: Scenesse European public assessment report ema.europa.eu
- BioSpace 2019: FDA approves first treatment to increase pain-free light exposure in EPP biospace.com
- Langendonk 2015, NEJM: afamelanotide for erythropoietic protoporphyria pubmed.ncbi.nlm.nih.gov
- Wensink 2020, JAMA Dermatology: afamelanotide outcomes in clinical practice pubmed.ncbi.nlm.nih.gov
- J Am Acad Dermatol 2023: consensus guidelines for EPP and X-linked protoporphyria pubmed.ncbi.nlm.nih.gov
- DailyMed: Scenesse label, warnings and precautions dailymed.nlm.nih.gov
- Langendonk 2015, NEJM (DOI) doi.org
Reference information only, not medical advice. Drawn from the Afamelanotide article, fact-checked against the cited sources. No dosing anywhere on this site.