FDA will issue a formal Safety Communication or draft guidance specifically addressing ibogaine cardiac monitoring requirements before December 31, 2026.

The FDA (US drug regulator) will publish an official warning or guidance document about heart safety risks from ibogaine, a psychedelic compound being tested as a treatment. Two recent scientific papers documented heart rhythm problems in ibogaine users, which triggers an FDA obligation to communicate these risks publicly to doctors and patients.

Two concurrent cardiac safety publications (QT-prolongation and arrhythmia findings) create a documented signal FDA is obligated to address. Precedent exists: FDA issued cardiac safety communications for antipsychotics within 6 months of comparable signal density. IND expansion is likely to stall pending protocol updates regardless of formal communication. Key uncertainty: FDA may act via informal IND hold letters rather than a public-facing Safety Communication, which would not satisfy this prediction's resolution criteria — hence a moderate downward adjustment from raw agent confidence.