US Consumer group seeks stronger warnings on Botox, similar treatments

Supernus Pharmaceuticals

12/12/2023 05:01

By Leroy  Leo
       Dec 12 (Reuters) - Consumer advocacy group Public
Citizen on Tuesday filed a petition with the U.S. Food and Drug
Administration seeking to require makers of Botox and several
similar injections to include stronger warnings about the risk
of a potentially fatal muscle-paralyzing disease.
    These injections, which use various versions of botulinum
toxins to contract specific muscles by blocking certain nerve
signals to erase wrinkles, already have a 'black box' warning in
their labels about the risks of the intended effect spreading to
other areas. The consumer group asked the FDA to make it clear
that these adverse effects could happen even at recommended
dosages.
    The new petition seeks a stronger warning on the label of
six toxin-based injections including market leader Botox from 
AbbVie  ABBV.V , Revance Therapeutics'  RVNC.O  Daxxify, Evolus'
 EOLS.O  Jeuveau, Supernus Pharmaceuticals'  SUPN.O  Myobloc,
Galderma's Dysport and Xeomin from Merz Therapeutics.
    Public Citizen also asked the FDA to remove promotional
statements that claim there are no definitive serious
side-effects of distant spread of toxin effect associated with
the toxins.
    The 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.
    The FDA maintains the database to help it identify unusual
or emerging side effect trends that may require further
investigation or actions, such as adding warnings to a product.
    The group is asking the FDA to add clear warnings about
systemic iatrogenic botulism, a condition that can cause
progressive muscle paralysis if the toxin used in these products
 spreads beyond the intended treatment site. 
    The FDA said it will review the petition and respond
directly to Public Citizen. Merz said it closely tracks the FDA
adverse event database, and submits safety reports to the agency
on a regular basis, while Revance and Evolus declined to
comment. The other companies did not respond to requests for
comment.
    An earlier petition by Public Citizen in 2008 based on an
analysis of 180 reports led to the FDA adding the current black
box warning about the risk of Botox's effect spreading to other
areas of the body. 
    The group is now asking the FDA to add a clearer warning
about the risk of botulism from Botox and other treatments. The
term "botulism" is only mentioned in the labeling of Botox and
related drugs once, toward the end of the prescribing
information, it said. 
    The 5,400 reported adverse events may be an understatement,
the advocacy group's health services researcher Azza AbuDagga
said, citing a study that found less than a tenth of adverse
events related to drugs are reported.
    The group is also asking the FDA to make it clear in labels
that botulism cases associated with recommended doses of the
products need prompt administration of botulinum antitoxins to
avoid disease progression.


 (Reporting by Leroy Leo in Bengaluru; Editing by Bill Berkrot)
 ((Leroy.Dsouza@thomsonreuters.com ; https://twitter.com/LeroyLeo7;))