FDA Early Communication Regarding Botox and Botox Cosmetic

The FDA reported today it is performing a “safety review” of Botox and Botox Cosmetic. The review is a result of adverse reactions reported when both A and B types of botulinum toxins were used for injections approved by the FDA and one that has not been approved by the FDA.

The FDA has approved Botox to treat spasms in the neck or eyelids and to reduce excess sweating; Botox Cosmetic to treat fine lines or wrinkles. Apparently there is information out in the medical community that the bolulinum toxins can also be used to treat severe muslce spasms in children and adults, primarily in cerebral palsy patients.

The FDA has not approved the toxins for any child under the age of 12 and has received adverse reaction reports of the toxin being used on children 16 and under. The adverse reactions range from a difficulty in swallowing or breathing which required breathing tubes or being placed on a ventilator to even death of the patient. There were similar adverse reports in adults; some were hospitalized, but there were no deaths reported.

Since the FDA has not finished its review of the adverse reaction reports, manufacturer safety data, medical literature and clinical studies, the FDA is not advising physicians to suspend use of the botulinum toxins. However, there are recommendations that should be followed:

Understand that potency determinations expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the next
Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
Understand that these effects have been reported as early as one day and as late as several weeks after treatment
Provide patients and caregivers with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin
Tell patients they should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness

There will be more communications on this subject as the FDA progresses with its studies.