๐ ็ธฝ็ฎ้ ๏ฝ ๐ ่ฑๆๅๆ๏ผๆฌ็ฏ๏ผ ๏ฝ ๐ ๅฎๆด็ฟป่ญฏ ๏ฝ โญ ็ฒพ่ฏ็ญ่จ
SAFETY
No long-term adverse effects have been reported, and no systemic safety problems have been associated with FDA-approved uses of BoNT. A review of the long-term safety of BoNT-A for cosmetic purposes revealed no serious adverse events (AEs) in over 850 treatment sessions for up to 9 years. An interim analysis of 768 patients enrolled in phase 3 clinical trials, who received up to six treatments of aboA, found that multiple treatments over 17 months were well tolerated. A large-scale, comprehensive phase III program of onaA for crowโs feet and glabellar rhytides comprising three trials, 684 patients, and up to four treatment cycles found no serious treatment-related AEs, evidence of distant spread of the toxin, or immunogenicity over a 12-month period. Side effects were mostly mild and included hematoma, headache, and injection-site hemorrhage. Treating both the crowโs feet region and glabellar rhytides at the same time did not result in an increased incidence of AEs, and side effects appeared to decline with repeated treatments.
However, the risk of serious complications increases with higher doses: in an analysis of 1031 AE reports submitted to the FDA, 407 occurred with higher therapeutic doses, including 28 deaths and other serious cardiovascular complications. The FDA could not determine a causal relationship between the fatalities and BoNT-A injections, especially since 26 patients who died had underlying cardiovascular diseases with an elevated mortality risk. Notably, no deaths or cardiovascular complications were associated with cosmetic doses. Similarly, another investigation of 658 FDA-submitted AEs, which included 180 cases of aspiration, dysphagia and/or pneumonia and 16 deaths, involved only