13 December 2023
Public Citizen urges FDA to enhance safety labeling for muscle-paralyzing injections
Public Citizen, a consumer advocacy group, has filed a petition with the U.S. Food and Drug Administration (FDA) demanding that manufacturers of Botox and other similar injections include stronger warnings about the risk of a potentially fatal muscle-paralyzing disease. The group argues that the current warnings on the labels of these injections do not adequately convey the potential adverse effects, which can occur even at recommended dosages. This petition comes after an analysis of thousands of reports documenting deaths, life-threatening events, and serious side effects related to these treatments. The FDA will review the petition and respond directly to Public Citizen.
Insufficient warnings prompt consumer group’s petition
The consumer group’s petition specifically targets six toxin-based injections, including the market leader Botox from AbbVie, Daxxify from Revance Therapeutics, Jeuveau from Evolus, Myobloc from Supernus Pharmaceuticals, Dysport from Galderma, and Xeomin from Merz Therapeutics. Currently, these injections carry a ‘black box’ warning on their labels, cautioning about the risk of the intended effect spreading to other areas. However, Public Citizen argues that the warnings fail to adequately address the potential dangers and urges the FDA to make it clear that adverse effects can occur even when recommended dosages are used.
The consumer group also calls for the removal of promotional statements that claim there are no definitive serious side effects associated with the distant spread of toxin effect from these injections.
Analysis of adverse events highlights the need for stronger warnings
Public Citizen’s petition is based on an analysis of over 5,400 reports of deaths, life-threatening events, and serious side effects related to Botox and similar toxin-based wrinkle treatments. These reports were recorded in the FDA’s adverse events database between January 1989 and March 2021. The group emphasizes that these adverse events may be an underestimate, citing a study that found less than 10% of adverse events related to drugs are reported. The FDA relies on this database to identify unusual or emerging side effect trends and take appropriate actions, such as adding warnings to products.
Request for clearer warnings about systemic iatrogenic botulism
Public Citizen’s petition also calls for clear warnings about systemic iatrogenic botulism, a condition that can cause progressive muscle paralysis if the toxin used in these injections spreads beyond the intended treatment site. The group argues that the current labeling does not adequately inform healthcare providers and patients about the risks associated with botulism. It notes that the term “botulism” is only mentioned once, toward the end of the prescribing information for Botox and related drugs.
Past success and potential implications
This is not the first time Public Citizen has petitioned the FDA regarding Botox. In 2008, the group’s earlier petition, based on an analysis of 180 reports, led to the addition of the current black box warning about the risk of Botox’s effect spreading to other areas of the body. Now, the advocacy group seeks to further enhance safety labeling by urging the FDA to include a clearer warning about the risk of botulism from Botox and other similar treatments. The implications of this petition could lead to improved safety information for healthcare providers and patients, ensuring that they are better informed about the potential risks associated with these injections.
Conclusion: Public Citizen’s petition to the FDA highlights the need for stronger warnings on the labels of Botox and similar injections. The consumer advocacy group argues that the current warnings do not adequately convey the potential risks, which can occur even at recommended dosages. By analyzing thousands of adverse event reports, the group brings attention to the need for clearer information about the risk of systemic iatrogenic botulism. The FDA will review the petition and respond directly to Public Citizen, and the outcome of this petition could have significant implications for the safety labeling of these popular cosmetic treatments.
