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Wednesday, August 5, 2009
Botulinum Toxin Drugs Get New Black Box Warning
Last month, we reported that the FDA was requiring stronger warnings on four types of botulinum toxin drug products. The most popular of the drugs affected by the warning change is Botox, which is commonly used in the United States for the off-label use of smoothing wrinkles. The FDA announced yesterday that all four of the botulinum toxin drug products now have a black box warning label on them.
The new warning cautions that the toxin used in the drugs, which is a variant of the bacteria that causes botulism, can migrate from the injection site to other areas of the body and can potentially cause symptoms similar to those experienced from botulism. The migration has mostly been reported when children with cerebral palsy are treated with the drug for muscle spasticity, an off-label use of the drug. In those children, the migration can cause severe adverse effects such as trouble swallowing and trouble breathing. No serious adverse effects have been reported from migration when the drugs are used for dermatologic purposes.
The new labels also caution health professionals that the four different types of botulinum toxin drugs are not interchangeable, because the units to measure each of the drugs are different. To help reduce the potential for dosing errors, the drugs have changed their established drug names (their generic names).
For more information, see the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175013.htm
See the Drug Safety Information for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174949.htm
See the update of Safety Review for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174959.htm
The new warning cautions that the toxin used in the drugs, which is a variant of the bacteria that causes botulism, can migrate from the injection site to other areas of the body and can potentially cause symptoms similar to those experienced from botulism. The migration has mostly been reported when children with cerebral palsy are treated with the drug for muscle spasticity, an off-label use of the drug. In those children, the migration can cause severe adverse effects such as trouble swallowing and trouble breathing. No serious adverse effects have been reported from migration when the drugs are used for dermatologic purposes.
The new labels also caution health professionals that the four different types of botulinum toxin drugs are not interchangeable, because the units to measure each of the drugs are different. To help reduce the potential for dosing errors, the drugs have changed their established drug names (their generic names).
For more information, see the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175013.htm
See the Drug Safety Information for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174949.htm
See the update of Safety Review for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174959.htm
Labels: Botox, botulinum toxin, botulism, cerebral Palsy, FDA
posted by
Colleen
at
6:43 AM
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