Excerpt from April 2009 letter written from the FDA/Department of Health and Human Services in response to the group Public Citizen regarding concerns raisde over the safety of botulinum toxin products (Botox, Dysport, etc.):
“Based on our analysis of reports in the AERS database, relevant clinical trial data, and published literature, we have notified the BLA holders for licensed botulinum toxin products of the need to develop a Medication Guide for distribution by physicians to patients at the time the product is injected. This reflects our determination that a REMS is necessary for these products in accordance with section 505-1(A) (1) and (2) of the Act, as applicable, to help ensure that the benefits of these products outweight their risks, and that a Medication Guide should be an element of the REMS under section 505-1(e)(2)(A) of the act. In accordance with 21 CFR 208.1(c)(1) and (c)(2), we have determined that botulinum toxin products pose serious and significant public health concerns requiring the distribution of a Medication Guide, and that these products have serious risks (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients’ decisions to use, or continue to use, these products. The Agency also has determined that patient labeling for botulinum toxin products could help prevent the consequences of serious adverse events. We consider this Medication Guide to be part of the labeling for which safety labeling changes are necessary under section 505(o)(4) of the Act, as well as an element of a REMS under section 505-1 (e)(2)(A) of the Act.
We have determined that a Medication Guide is an appropriate additional method of communicating the signs and symptoms of the spread of botulinum toxin effect to the patient or the caregiver. ….The Patient Counseling Information section of botulinum toxin product labeling will be revised to state that the physician should provide a copy of the FDA-approved Medication Guide and review the contents with the patient. ”
Were YOU given a copy of the Medication Guide?