Consumer Group Urges FDA to Strengthen Warnings on Botox and Competing Treatments
Consumer advocacy group Public Citizen has filed a petition with the U.S. Food and Drug Administration (FDA) requesting stronger warnings on the labels of Botox and similar injections regarding the risk of a potentially fatal muscle-paralyzing disease. The group analyzed over 5,400 reports of deaths, life-threatening events, and serious side effects related to these treatments and found that the current warnings are insufficient. They are asking the FDA to clarify that adverse effects can occur even at recommended dosages and to remove promotional statements claiming no definitive serious side effects. The FDA will review the petition and respond directly to Public Citizen.