Manufacturers of botulinum toxin products (Botox, Botox Cosmetic, Myobloc) required to strengthen warnings

The FDA has notified healthcare professionals that it is requiring the manufacturers of licensed botulinum toxin products, including Botox and Botox Cosmetic (botulinum toxin type A, from Allergan) and Myobloc (botulinum toxin type B, from Solstice Neurosciences), to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spreads beyond the injection site.

The FDA will also require the manufacturers to develop and implement a Risk Evaluation and Mitigation Strategy (REMS). The REMS will include a Communication Plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection and explain that botulinum toxin products are not interchangeable. A Medication Guide will also be included that explains the risks to patients, their families, and caregivers. Additionally, the FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

Botulinum toxin products have been approved by FDA for one or more of the following indications:  temporary improvement in the appearance of glabellar lines, treatment of strabismus, blepharospasm, cervical dystonia, and primary axillary hyperhidrosis.

For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm143819.htm.