FDA warns Min­neso­ta doc for run­ning two ke­t­a­mine tri­als with­out INDs, and with chil­dren and a preg­nant woman

The FDA on Tues­day re­leased a warn­ing let­ter sent to a Min­neso­ta physi­cian who failed to ex­clude vul­ner­a­ble pop­u­la­tions from two clin­i­cal tri­als com­par­ing the anes­thet­ic ke­t­a­mine with haloperi­dol and mi­da­zo­lam as po­ten­tial se­vere ag­i­ta­tion treat­ments.

The let­ter makes clear that not on­ly did Jon Cole, emer­gency doc at Min­neapo­lis’ Hen­nepin Coun­ty Med­ical Cen­ter, nev­er file INDs for the tri­als with the FDA, as re­quired by law, he al­so didn’t write ap­pro­pri­ate pro­to­cols to en­sure that chil­dren and preg­nant women weren’t en­rolled, and didn’t ex­clude those who were un­der the in­flu­ence of in­tox­i­cants, in whom the use of ke­t­a­mine is cau­tioned.

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