Neurologic symptoms reported after botulinum neurotoxin injections
Key Mechanisms
Possible explanations included unknown product concentration, contamination, or improper preparation, administration, or storage; the investigation did not determine a cause.
Target Population
Patients receiving botulinum neurotoxin injections, particularly from unapproved products or unauthorized suppliers
Care Setting
Medical spa injection practice investigated by public health authorities
Key Highlights
Three women reported neurologic symptoms after receiving the same unapproved botulinum neurotoxin product at a Colorado medical spa.
Reported symptoms included dysphonia, headache, blurred vision, limb numbness or weakness, neck stiffness, and dyspnea.
All three women recovered without hospitalization; one sought outpatient medical care.
The investigation found injection safety violations involving product sourcing, diluent, vial use, temperature monitoring, and beyond-use dates.
The implicated product lot was unavailable for testing, and investigators did not establish the cause of the symptoms.
Guideline-Based Recommendations
Diagnosis
Assess for neurologic symptoms following botulinum neurotoxin injections; reported symptoms in this investigation included dysphonia, blurred vision, dyspnea, headache, sensory symptoms, and muscle weakness.
Management
Do not purchase or administer unapproved botulinum neurotoxin products from unauthorized suppliers.
Report adverse events following botulinum neurotoxin injections through FDA MedWatch.
Monitoring & Follow-up
Maintain appropriate temperature monitoring and observe product storage and beyond-use dates.
Use single-dose vials for one patient, consistent with the safety violations identified in the investigation.
Risks
The investigation identified possible risks related to unknown product concentration, contamination, and improper preparation, administration, or storage; it did not determine which, if any, caused the reported symptoms.
Patient & Prescribing Data
Three women received injections from the same product lot in the upper brow, glabella, or upper lip; reported doses were 24, 3, and 10 units.
All three reported symptoms after treatment and recovered without hospitalization. None knew the product was not FDA-approved.
Clinical Best Practices
Avoid purchasing or administering unapproved products from unauthorized suppliers.
Follow safe product preparation, administration, storage, and vial-use practices.
Report adverse events following botulinum neurotoxin injections through FDA MedWatch.
