We are thrilled to announce that we have received word that the U.S. consumer advocacy group, Public Citizen has filed a petition with the FDA seeking to require more extensive warnings on botulinum neurotoxin injections. They have sought to include stricter warnings about the development and risk of acquiring botulism, even at recommended dosing.
In one of our recent Instagram posts, we too have disputed the manufacturer's statement that appears in labeling that there are "no definitive serious side effects of distant spread of toxin effect, at recommended dosages." After review of adverse event cases in the FDA's reporting database, FAERS our post includes proof that this statement is false. To see the post please click HERE.
This "request comes after the advocacy group analyzed over 5,400 reports of deaths, life-threatening events and other serious side effect related to Botox and rival toxin-based wrinkle treatments between January 1989 and March 2021 that were recorded in FDA's adverse events database, Leroy Leo." To read the REUTERS article, please click HERE.
As we have fiercely worked to create more public awareness, patient safety, and informed consent surrounding botulinum neurotoxins for nearly a decade, we are relieved and grateful that Health Researcher, Azza AbuDagga, MHA, Ph.D. of Public Citizen has also seen the alarming numbers of adverse events at recommended dosing, and has recongized an intense issue with underreporting. We extend our deepest gratitude to her and the other members of Public Citizen. We are elated to know that other professional organizations are working alongside of us to build a safer and healthier world for all.
For media inquiries please see our Media tab. To join the largest International Botox injury support group, please click HERE.
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