What is the duration of use for Botulinum toxin (Botox)?

From the Guidelines

Botox has been around for medical use since 1989 when it was first approved by the FDA for treating eye muscle disorders like strabismus and blepharospasm. The history of Botox dates back to the 1940s when the active ingredient, botulinum toxin type A, was isolated and began being studied for therapeutic purposes in the 1970s 1. However, it wasn't until 1989 that Botox received FDA approval for medical use, and later in 2002 for cosmetic purposes to temporarily reduce the appearance of facial wrinkles.

Key Points

• Botox works by temporarily blocking nerve signals to muscles, causing them to relax and reducing the appearance of wrinkles or treating various medical conditions.
• The effects typically last 3-4 months before gradually wearing off, requiring repeat treatments to maintain results.
• Despite being derived from the same toxin that causes botulism, Botox is considered safe when administered properly by qualified healthcare professionals in appropriate doses, as seen in its use for conditions like lower extremity spasticity and chronic migraine 1.
• Other studies have also explored the use of Botox in various medical conditions, including Bell's palsy, where botulinum injections may improve eyelid closure for a period of months 1.

Medical Use

The medical use of Botox has been established for several conditions, including:

• Lower extremity spasticity, where onaBoNT-A and aboBoNT-A are safe and effective treatments 1.
• Chronic migraine, where onaBoNT-A has been established as safe and effective for increasing the number of headache-free days 1.
• However, Botox is probably an ineffective treatment for tension-type headaches and should not be offered 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

History of Botox

• Botox, also known as onabotulinumtoxinA, has a long history dating back to the 1970s when Dr. Scott was attempting to identify an injectable substance to weaken extraocular eye muscles in patients with strabismus 2.
• The development of Botox as a medical treatment began in the 1970s and 1980s, with the first manufacturing methods and quality control procedures being developed for Oculinum, the botulinum toxin type A product that would eventually be sold to Allergan and become known as Botox 2.
• Botox was first approved by the US Food and Drug Administration in 1989 for the treatment of blepharospasm and strabismus 3.

Evolution of Botox Use

• The clinical use of onabotulinumtoxinA evolved based on strategic, hypothesis-driven applications, as well as serendipitous observations by physicians and patients 4.
• The success of onabotulinumtoxinA in blepharospasm and strabismus led to its study in other head and neck dystonias, followed by limb dystonia, tremor, and spasticity 4.
• The aesthetic use of onabotulinumtoxinA followed initial reports from patients of improved facial lines after injections for facial dystonias and hemifacial spasm 4.

Timeline of Botox Development

• 10th century: Outbreaks of food poisoning led to the discovery of botulinum toxin 3.
• 1970s: Dr. Scott began developing Botox as a treatment for strabismus 2.
• 1989: Botox was first approved by the US Food and Drug Administration for the treatment of blepharospasm and strabismus 3.
• 2020s: Botox continues to be used for a variety of medical and aesthetic purposes, with ongoing research into its potential uses and effects 5, 6, 4.