Alerts
Botulinum Toxin Types A (Botox, Botox Cosmetic, Dysport) and Botulinum Toxin Type B (Myobloc) – Safety Review Update and Names Changed to OnabotulinumtoxinA (Botox, Botox Cosmetic), AbobotulinumtoxinA (Dysport), and RimabotulinumtoxinB (Myobloc)
August 4, 2009
After an ongoing safety review, initiated in February 2008, FDA is requiring the manufacturers of licensed botulinum toxin products (Botox, Botox Cosmetic, Dysport, and Myobloc) to change the established names of these products to reinforce that the products are not interchangeable and to reduce the risk of medication errors. The manufacturers were also required to add a boxed warning and additional warnings in the product information to address the risks of toxin spreading beyond the local injection site. Most reports of toxin spreading occurred in patients being treated for spasticity and cervical dystonia, although some non-serious distant spread has been reported in patients receiving the products for dermatologic use. Reactions to distant spread can include hospitalization and death and may occur between hours to several weeks after administration of a wide dosage range of these products for multiple conditions.
A post marketing review showed adverse events (eg hospitalization, death) in pediatric cases were mainly associated with treatment of spasticity in children with cerebral palsy, an unapproved use. Although deaths were reported in adults, it is unclear whether they were from botulinum toxin or other underlying conditions. However, there are reports of hospitalization, including need for mechanical ventilation, in adults receiving the botulinum toxin.
In addition to the warnings, the FDA and United States Adopted Names Council (USAN) have changed the established drug names for these products to reduce the risk of medication errors and to reinforce that drug potency differs between the agents. The new established names are onabotulinumtoxinA (Botox, Botox Cosmetic), abobotulinumtoxinA (Dysport), and rimabotulinumtoxin B (Myobloc). Potency units are specific to each product and may not be converted between products. The product trade names or marketed formulations are not changing.
FDA is requiring the manufacturers to develop a Risk Evaluation and Mitigation Strategy (REMS) that includes a Communication Plan providing more information about the risk of spread of the toxin after a local injection and that products are not interchangeable. A Medication Guide explaining the risks to consumers would also be included in the REMS. Manufacturers must also submit safety data for children and adults receiving multiple injections for spasticity.
FDA still recommends healthcare professionals be aware of the differences in dosing and units between products, understand the signs and symptoms of botulism, and educate patients to recognize these symptoms which include dysphagia, dysphonia, dyspnea, weakness, or respiratory distress.
Additional information is available at the following links:
FDA MedWatch Alerts:
- August 2009:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164255.htm - April 2009:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164255.htm - February 2008:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079766.htm
Information about HealthCare Professionals:
Communication about Ongoing Safety Review:
- August 2009:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm174959.htm - April 2009:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm143819.htm - February 2008:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm070366.htm
The FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. This requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1). However, it may be appropriate to educate inpatients about the potential hazards of prescription medications, at the clinician’s discretion. The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/cder/Offices/ODS/labeling.htm.
Updated
August 4, 2009; May 7, 2009; February 12, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
