Article

Allergan issues comments about FDA review

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.

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)  ASCRS 2025: Joaquin De Rojas, MD, leverages machine learning model to predict arcuate outcomes
(Image credit: Ophthalmology Times) ASCRS 2025: AnnMarie Hipsley, DPT, PhD, presents VESA for biomechanical simulation of presbyopia progression
Shehzad Batliwala, DO, aka Dr. Shehz, discussed humanitarian ophthalmology and performing refractive surgery in low-resource, high-risk areas at the ASCRS Foundation Symposium.
(Image credit: Ophthalmology Times) ASCRS 2025: Advancing vitreous care with Inder Paul Singh, MD
(Image credit: Ophthalmology Times) The Residency Report: Study provides new insights into USH2A target end points
Lisa Nijm, MD, says preoperative osmolarity testing can manage patient expectations and improve surgical results at the 2025 ASCRS annual meeting
At the 2025 ASCRS Annual Meeting, Weijie Violet Lin, MD, ABO, shares highlights from a 5-year review of cross-linking complications
Maanasa Indaram, MD, is the medical director of the pediatric ophthalmology and adult strabismus division at University of California San Francisco, and spoke about corneal crosslinking (CXL) at the 2025 ASCRS annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Taylor Strange, DO, assesses early visual outcomes with femto-created arcuate incisions in premium IOL cases
(Image credit: Ophthalmology Times) ASCRS 2025: Neda Shamie, MD, shares her early clinical experience with the Unity VCS system
© 2025 MJH Life Sciences

All rights reserved.