Botox Approved for Children

FDA approves Botox (onabotulinumtoxinA) for upper limb spasticity in children

(RxWiki News) The US Food and Drug Administration (FDA) has approved a medication to ease upper limb spasticity in children.

This medication is known by the brand name Botox, and the active ingredient is onabotulinumtoxinA. The FDA recently approved it for children between the ages of 2 and 17.

Spasticity is defined as stiff or rigid muscles. Cerebral palsy, multiple sclerosis, spinal cord injuries, stroke and traumatic brain injuries are all conditions that can lead to spasticity in children.

This approval offers children with spasticity a new treatment option. The injection can help increase movement in the areas that are affected by stiff muscles.

It is important to note that onabotulinumtoxinA is not a replacement for existing physical therapy or other rehab efforts.

This medication is currently used to treat upper and lower limb spasticity in adult patients, among other uses like the treatment of overactive bladder and headache prevention with chronic migraines.

OnabotulinumtoxinA is also approved to improve the look of wrinkles (found under the name Botox Cosmetic).

This new approval is available as an injection. The recommended dose is between 3 and 6 units/kg, which will be divided among the affected muscles.

When used to ease upper limb spasticity in children, this drug may produce side effects like upper respiratory tract infections.

This medication also comes with a boxed warning — the strongest type of warning — that notes a risk for the spread of toxin effect. That means there is a possibility for the effects of this medication to spread from the area of injection, which can lead to symptoms consistent with botulinum toxin effects. These symptoms can show up hours to weeks after the injection. Furthermore, swallowing and breathing difficulties can happen and can be life-threatening.

Talk to your health care provider about any concerns or questions you have.

Last Updated:
June 28, 2019