Article

Allergan issues comments about FDA review of botulinum toxin A

Irvine, CA-The FDA’s recent announcement that it is reviewing serious adverse effects, including death, that have occurred following the use of botulinum toxins for the management of juvenile cerebral palsy and other large-muscle, lower-limb spasticities applies primarily to the non-cosmetic formulation of botulinum toxin type A (Botox) rather than the cosmetic version (Botox Cosmetic), Allergan said in a statement.

Irvine, CA-The FDA’s recent announcement that it is reviewing serious adverse effects, including death, that have occurred following the use of botulinum toxins for the management of juvenile cerebral palsy and other large-muscle, lower-limb spasticities applies primarily to the non-cosmetic formulation of botulinum toxin type A (Botox) rather than the cosmetic version (Botox Cosmetic), Allergan said in a statement. The company markets both products.

Non-cosmetic botulinum toxin type A is used to treat a variety of medical conditions, such as strabismus and blepharospasm associated with dystonia. It is approved for the treatment of juvenile cerebral palsy in about 60 countries and is used off-label for the indication in the United States, according to Allergan. The cosmetic formulation is approved at different doses by the FDA for the aesthetic treatment of wrinkles between the brows.

The FDA has not said that a causal relationship exists between use of the products and the side effects, the company pointed out.

“With respect to the therapeutic use of [botulinum toxin type A] to treat juvenile cerebral palsy and other lower-limb spasticities, one should keep in mind that the population, treatment paradigms, and typical dosing of product is significantly greater than [with] some of the other approved uses of the product, including specifically the FDA-approved use of [the cosmetic formulation] to treat wrinkles between the brows,” the Allergan statement said. “In particular, the FDA on its teleconference pointed out that this population of patients tends to be ‘very sick’ and that, sadly, this population is generally subject to greater-than-usual serious adverse events and a higher mortality rate than a healthy population, regardless of the use of the product.”

Approved dosing of the cosmetic formulation is 20 units, the company said, adding that the FDA noted that reported adverse events were associated with doses ranging from 100 to 700 units. “The difference is higher still on a per-kilogram of body weight basis, as this population often involves young and lower-weight patients than the generally healthy adult population seeking a [cosmetic botulinum toxin type A] treatment,” Allergan said.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) From MIGS to gene therapy: Inder Paul Singh, MD, celebrates the past and future of glaucoma care
(Image credit: Ophthalmology Times) NeuroOp Guru: Using OCT to forecast outcomes in ethambutol optic neuropathy
(Image credit: Ophthalmology Times) Inside NYEE’s new refractive solutions center with Kira Manusis, MD
(Image credit: Ophthalmology Times) Dilsher Dhoot, MD, on the evolution of geographic atrophy therapy: where are we now?
(Image credit: Ophthalmology Times Europe) Anat Loewenstein, MD, shares insights on the real-world results of remote retinal imaging
(Image credit: Ophthalmology Times) Two-wavelength autofluorescence for macular xanthophyll carotenoids with Christine Curcio, PhD
(Image credit: Ophthalmology Times) FLIO and the brain: Making the invisible visible with Robert Sergott, MD
(Image credit: Ophthalmology Times) Structure-function correlates using high-res OCT images with Karl Csaky, MD, PhD
(Image credit: Ophthalmology Times) SriniVas Sadda, MD, on high-res OCT of atrophic and precursor lesions in AMD
© 2025 MJH Life Sciences

All rights reserved.