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FDA Approves Merz Pharmaceuticals' Xeomin® (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
Date:8/2/2010

nd previously treated patients and blepharospasm in adults previously treated with Botox® (onabotulinumtoxinA). Please see important safety information below.

More than 84,000 patients have been treated with XEOMIN worldwide since 2005. The U.S. is the 20th country to approve XEOMIN for the treatment of cervical dystonia and blepharospasm.

Important Safety Information About XEOMIN

WARNING: Distant Spread of Toxin Effect

The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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, particularly in those patients who have underlying conditions that would predispose them to these symptoms.  See full prescribing information for complete boxed warning.

WARNINGS AND PRECAUTIONS

  • The potency Units of XEOMIN are not interchangeable with other preparations of botulinum toxin products.  Therefore, units of biological activity of XEOMIN cannot be compared to or converted into units of any other botulinum toxin products.
  • Spread of toxin effects may cause swallowing and breathing difficulties that can lead to death. Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties. Use with caution in patients with compromised respiratory function or dysphagia. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.
  • Hypersensitivity reac
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SOURCE Merz Pharmaceuticals, LLC
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