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FDA will issue a formal Safety Communication specifically on ibogaine-associated cardiac risks (QT prolongation/arrhythmia) before December 31, 2026.

Predicted 2026-05-12 · Resolves 2026-11-30 · regulation · USA
38%
ORACLE CONFIDENCE
⏳ Pending
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The FDA (the U.S. drug regulator) will publish an official warning about ibogaine's documented risk of causing dangerous heart rhythm problems. This matters because people are seeking ibogaine treatment overseas for PTSD and addiction, but the FDA hasn't yet formally warned Americans about the specific cardiac danger, even though deaths have been documented.

Multiple ibogaine cardiac safety papers published in a single adverse event signal cycle represents an unusual concentration of safety data. FDA has institutional incentive to issue communications when a drug class is attracting IND interest and documented cardiac deaths exist. However, FDA communications timelines are slow and this prediction duplicates prediction #3 below. Confidence is moderate; FDA may choose to act through IND-specific guidance rather than a broad Safety Communication.

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