The U.S. Food and Drug Administration (FDA) is warning that three products: Botox, Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) have been linked to fatal adverse reactions including respiratory failure. The most severe adverse reactions have occurred in children with cerebral palsy, who rely on the drug for treatment of limb spasticity. The FDA warns that it has not approved any Botulinum toxins for treatment of spasticity in either children or adults, though it is not advising healthcare professionals to stop prescribing the products at this time.
The agency maintains that there is presently no reason to suspect that these adverse outcomes are related to any defect in the product, and that many dangerous reactions appear to be attributable to accidental overdosing. Potency determinations of the three Botulinum products are not identical and consequently, appropriate dosages of the three products differ.
The FDA is currently making the following Botulinum product recommendations to healthcare providers:
- "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"
The agency is reviewing safety data from clinical studies and adverse event reports related to Botulinum products. After a thorough review, its conclusions will be made public, and any recommendations or regulatory action will be announced at that time.
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- Cerebral palsy: Answers and advocacy
- Evidence that in-vitro fertilization can increase the risk of cerebral palsy
- A new study indicating that children with cerebral palsy generally consider their quality of life to be as good as that of any typical 8- to 12-year-old
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