We also urge the agency to remove promotional claims that mislead the public and evade the warning included in the box from the onabotulinumtoxinA (Botox, Botox Cosmetic) labeling. Therefore, this petition asks the FDA to clarify the potential risk of contracting systemic iatrogenic botulism and related symptoms, as well as the need to administer botulinum antitoxin, in the warning box that appears on the label of tuberculosis products. The Food and Drug Administration (FDA) will reinforce safety warnings on labels for botox and botox cosmetics and will eliminate misleading promotional statements currently on labels. Of the total 121 reports on botulism, 100 (82.64%) were notified to the FDA after meeting the requirement to include warning in a box. The majority (79.55%) of the reports containing annulment information and 55.36% of those containing rebuttal information referred to reports prior to the warning box requirement.
In this petition, the current warning about tuberculosis products does not explicitly mention the potential risk of systemic iatrogenic botulism and related symptoms; on the contrary, it dilutes and conceals this serious risk by limiting its wording to the euphemism of “remote spread of the toxin”. Second, the risk of distant spread of tuberculosis products contained in the warning box is only emphasized in the context of spasticity treatment (especially in children) and in patients with certain other underlying conditions. Modify the warning box on the label of the products AbotulinumToxina (Dysport), DaxibotulinumToxin-LANM (Daxxify), IncobotulinumToxin (Xeomin), OnabotulinumToxin (Botox, Cosmetic), PrabotulinumToxin-XVFS (Jeuveau) and RimabotulinumToxinB (Myobloc) to emphasize the risk of serious systemic iatrogenic botulism. In addition to a reinforced warning in the form of a black box, the petition asks the FDA to remove three misleading promotional statements from Botox and Botox Cosmetic labels.
From this request, it is up to the FDA to demand that these misleading statements be eliminated, since they only serve to evade the warning in the box and cause the label of the onabotulinum cosmetic TOXinA (Botox Cosmetic) to be mislabeled, in accordance with the Drugs and Drugs Act. In addition, of these latest reports, 1,868 (66.31%) were notified to the FDA after meeting the requirement to include a warning in a box. Although the incidence of this risk appears to be low, it should be clearly indicated in the warning box of these products. Failure to do so would mislead doctors and patients to discount the warning in the warning box for these products and, possibly, for other approved BT products as well.
