Today: March 04, 2024
Today: March 04, 2024

US Consumer group seeks stronger warnings on Botox, similar treatments

Share This
US Consumer group seeks stronger warnings on Botox, similar treatments
Reuters
Leroy Leo
December 11, 2023

By Leroy Leo

(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, Revance Therapeutics' Daxxify, Evolus' Jeuveau, Supernus Pharmaceuticals' 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)

Popular

Brothers Travis and Jason Kelce honored with bobblehead giveaway at Cavs-Celtics game

Taylor Swift’s boyfriend has taken shaking it off to another level

Takeaways from Trump's Supreme Court win on procedural grounds: His legal peril is just starting

:Former President Donald Trump scored a clear win at the U.S. Supreme Court on Monday, which unanimously ruled that states don’t have the ability to bar him — or any other federal candidates — from the ballot under a rarely-used constitutional provision that prohibits those who “engaged in insurrection” from holding office

Goldman, New York mayor make $50 million pledge on affordable housing

NEW YORK (Reuters) - Goldman Sachs and the New York City Mayor's Office on Monday announced a $50 million initiative to support minority-owned affordable housing developers.

Netanyahu leaned on his top rival to help unify Israel. Now, Benny Gantz is more popular

Benny Gantz, who is in Washington this week for meetings with U.S. leaders, is a crucial member of Israel’s War Cabinet

'Uncommitted' protest aims at Minnesota over Biden's Israel support

By Nandita Bose MINNEAPOLIS (Reuters) - The "uncommitted" movement to pressure U.S.

Yemen's Houthis say they targeted 'Israeli ship MSC SKY' in the Arabian Sea

CAIRO (Reuters) - Houthi military spokesperson Yahya Sarea said on Monday the Iran-aligned group had targeted the "Israeli ship MSC SKY" in the Arabian sea.

Related

First lady Jill Biden honors 'women of courage' at White House

First lady Jill Biden is hosting a White House ceremony honoring “women of courage” from around the world

US sanctions Zimbabwe president Emmerson Mnangagwa over human rights abuses

The United States has sanctioned Zimbabwe’s President Emmerson Mnangagwa, the First Lady and other government officials for their alleged involvement in corruption and human rights abuses

Settlement in Wisconsin fake elector case offers new details on the strategy by Trump lawyers

Two attorneys for then-President Donald Trump orchestrated a plan for fake electors to file paperwork falsely saying he won Wisconsin in a strategy to overturn Joe Biden’s 2020 victory there

Ohio foundation begins process to distribute millions in opioid settlement money

Ohio is ready to begin doling out hundreds of millions of dollars in opioid settlement money to community and government organizations

- Advertisement -
Advertisement: Limited Time Offer