August 7th, 2009
The US FDA has announced and advised healthcare providers of modifications to the well-known drug names for Botox / Botox Cosmetics, Dysport and Myobloc. These modifications are in the hopes to provide healthcare professionals advice on how to avoid medication inaccuracy, and reinforce individual potency. The modifications are also to provide additional information to patients, family members and caregivers.
Since the FDA began their safety review in February of 2008, they have informed healthcare providers that manufacturers of licensed botulinum toxin products are forced to reinforce product label warnings and include a boxed warning of the chances of harmful effects when the impacts of the toxin extends over the original site of injection.
The FDA has also demanded that manufacturers create and execute a Risk Evaluation and Mitigation Strategy, which will comprise of a communication plan to supply added advice regarding local injection risks coupled with the distant spread of botulinum toxin effects, as well as documentation explaining that botulinum products cannot be interchanged. The REMS also includes a risk factor Medication Guide for patients, families and caregivers. The FDA requires manufacturers to present safety data after numerous administrations of the product in a determined number of children and adults with spasticity to access the signal of serious risk regarding distant spread of toxin effects.
