Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), gave FDA authority to require safety labeling changes. The FDA review for safety of BOTOX started February 2008, the conclusion of this review was introduced by implementation of a Risk Evaluation and Mitigation Strategy (REMS) that includes a BOTOX®/BOTOX® Cosmetic Medication Guide to provide to patients being administered BOTOX. The REMS has been implemented to ensure that the benefits of BOTOX®/BOTOX® Cosmetic treatment outweigh the potential risks of BOTOX®/BOTOX® Cosmetic treatment. The goals of the BOTOX®/ BOTOX® Cosmetic REMS are to:
- Minimize the risks of medication errors related to the lack of interchangeability of BOTOX®/ BOTOX® Cosmetic Units with those of licensed botulinum toxins of other manufacturers
- Inform prescribers and patients about the potential occurrence of spread of toxin effect beyond the injection site
The strategy requires that an FDA-Approved Patient Medication Guide for BOTOX® be sent to health care providers who are administering Botox and to patients each time Botox is administered.
Non-Interchangeability of Botulinum Toxin A products
Because the potency units of BOTOX®/BOTOX® Cosmetic Units are specific to the preparation and assay method utilized, it is not interchangeable with other Botulinum Toxin A products such as DYSPORT TM manufactured by the Ipsen Group. To address this issue, Allergan, in conjunction with the FDA and the United States Adopted Names Council, has adopted the established the name onabotulinumtoxinA that is specific to BOTOX® . This uniquely established nonproprietary name replaces the previous common terms Botulinum Toxin Type A and differs from the established name for DYSPORT™ (abobotulinumtoxinA) .
Distant Spread of Toxin Effects
Postmarketing reports indicate that the effects of BOTOX®/BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. Therefore patients, care-givers, and/or parents must be vigilant about be on the alert for these symptoms. The risk is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of toxin effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses. The REMS requires a periodic evaluation on its’ effectiveness. The timeline for evaluation is 18month, 3years, or 7 years. FDA may eliminate the REMS requirement if after 3 years if it is managed well.