Consumer group presses for stronger Botox warnings

BY TARA SUTER - 12/12/23 

A shop offers ‘Botox to go’ in Berlin, Germany, Wednesday, Jan. 4, 2017. (AP Photo/Michael Sohn)

A consumer group is pushing the Food and Drug Administration (FDA) for stronger Botox warnings, pointing to the danger of negative health effects from the cosmetic injections.

In a Tuesday petition, Public Citizen asks the agency to “take action to strengthen the risk warning on the labeling of all approved botulinum toxin biological products.”

It warns that the use of “cosmetic and therapeutic” versions of the aforementioned products at “recommended doses” can still result in negative health effects.

“The petition asks that the black box warning of both cosmetic and therapeutic Botox and related drugs should make it clear that they are associated with systemic iatrogenic botulism and related symptoms, even when used at recommended doses, in initial or subsequent (repeated) treatment,” a press release by Public Citizen on the petition reads. 

It specifically points to the risk of “descending muscle paralysis or weakness.”

“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” said Azza AbuDagga, health services researcher at Public Citizen’s Health Research Group, in a statement.

The Hill has reached out to the FDA for comment on the petition.

The usage of Botox recently came into the national spotlight, with former Rep. George Santos (R-N.Y.) allegedly inappropriately using campaign funds on the drug, according to a House Ethics Committee report. 

In an emailed statement to The Hill, the FDA said it “will review the petition and respond directly to the petitioner.”

Updated at 12:42 pm.