ST LOUIS (MD Consult) - On April 30, 2009, the US Food and Drug Administration (FDA) issued a follow-up notification about actions taken in regard to data derived from a continuing safety review of licensed botulinum toxin products. Manufacturers of these products will now be required to strengthen warnings in product labeling and to add a boxed warning regarding the risk of adverse events that may occur when the effects of the toxin spread beyond the injection site.
The FDA will also require that manufacturers of botulinum toxin products develop and implement a Risk Evaluation and Mitigation Strategy (REMS), including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a medication guide that explains these risks to patients, their families, and caregivers. In addition, as a means to further assess the risk of distant spread of toxin effects, the FDA is requiring manufacturers to submit safety data gathered from a specified number of children and adults with spasticity after they have received multiple administrations of the product.
The FDA's evaluation of the data continues to support the recommendations made in their 2008 early communication on the safety of botulinum toxins types A and B.
