BOT - Anything but charting, page-6931

sounds very similar to Oxy in Dopesick….

therapeutic BT products — even when used at recommended doses, either during initial or subsequent (repeated) treatment — are associated with systemic iatrogenic botulism or related symptoms, which may require prompt administration of botulinum antitoxin to avoid disease progression and possible serious outcomes, including temporary paralysis, hospitalization, and even death. This risk is neither adequately clear nor emphasized in the current labeling of these products. Instead, it is masked with the euphemism of "distant spread of toxin effect" beyond injection sites. Furthermore, the current FDA-approved labeling of BT products discusses the need to administer botulinum antitoxin only in the context of excessive dosing, accidental injection, or oral ingestion of these products. Therefore, this petition requests that the FDA make the potential risk of systemic iatrogenic botulism and related symptoms, and the need to administer botulinum antitoxin, clear in the boxed warning on the labeling of BT