Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
BOXED WARNING (EDITED)
WARNING: DISTANT SPREAD OF TOXIN EFFECT
- Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.
What is the most important information I should know about DYSPORT?
DYSPORT may cause serious side effects that can be life threatening including:
- Problems breathing or swallowing
- Spread of toxin effects
These problems can happen within hours, or days to weeks after an injection of DYSPORT. Call your doctor or .......
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. Using DYSPORT with certain other medicines may cause serious side effects.
- added..... Do not start any new medicines until you have told your doctor that you have received DYSPORT in the past.