FDA Concerned Over Behavior-Changing Shock Devices
In an advisory report drafted for the 2014 Neurological Devices Panel, the FDA is considering a ban on electrical stimulation devices (ESDs) for aversive conditioning of patients exhibiting self-injurious behavior (SIB) and aggressive behavior. The FDA is concerned that ESDs pose a substantial and unreasonable risk of illness or injury when used in this fashion.
Identified risks include negative emotional reactions/behaviors, burns and other tissue damage, anxiety, acute stress/PTSD, and fear. Literature suggests short-term benefit with ESD usage, but many concerns exist regarding treatment robustness and long-term efficacy.
Currently, only two pharmacological treatments are approved for autism spectrum disorders: risperidone and aripiprazole. The efficacy of pharmacologic treatment for SIB and aggressive behavior is generally considered effective, although the specific rates of improvement in the literature are varied due to methodological limitations of those studies. Other agents studied in the treatment of aversive behavior include other atypical antipsychotics, selective-serotonin reuptake inhibitors (SSRIs), opioid antagonists, anticonvulsants, and alpha agonists.
The most common treatment modality for SIB and aggressive behavior in individuals with intellectual impairment and developmental spectrum disorders remain behaviorally based, such as reinforcement-based and extinction-based treatments.
For more information visit FDA.gov.