Psychotropic Medications & The Black Box Warning

I always try to be as conservative as possible with all psychotropic meds in my patients with dementia.    I first look at the complete medication list and see if there are any meds which we can remove rather than add (in case they are contributing to current symptoms).  The only medications FDA approved for dementia are cholinesterase inhibitors (e.g. donepezil, rivastigmine & galantamine) & memantine.  They typically help primary & cognitive symptoms of dementia.  They can sometimes (but not always) help the neuropsychiatric manifestations of dementia (e.g. insomnia, anxiety, agitation or hallucinations).     

All antipsychotics carry a FDA warning to use with extreme caution in patients with dementia.  Some studies have found a 2% risk of dying sooner in patients with dementia who take these meds (usually through cardiovascular illness like heart attack, stroke, or sudden death).  There was at least one study refuting this finding.  Psychiatry & use of psychotropic medications are not exact sciences (i.e. there is a lot of gray area).  We should certainly heed the warning, but also look at the big picture.  Because treatment options can be limited in those with dementia, sometimes these meds are the best choice (i.e. "the lesser of all evils") to treat symptoms like hallucinations & paranoia, or even agitation, anxiety & insomnia.   

I want to point out that the black boxwarning is partially a sociopolitical construct.  In other words, these warnings appear when something gets a lot of negative press.  For example, opiates got a black box warning because of severe addiction & deaths related to overdose.  There is another group of medications called benzodiazepines.  This includes lorazepam (aka Ativan) & other meds you may have heard of like diazepam (aka Valium), alprazolam (aka Xanax) & clonazepam (aka Klonopin).  This group of medicines is the #1 medication cause of falls in the elderly.  All it takes is one bad fall, and somebody dies or has a severe injury.   There is no black box warning on these meds, but I view them as just as dangerous (if not more) as antipsychotics. Each group of meds has different risks.  Benzodiazepine can receive anxiety quickly, but besides falls can also lead to confusion & sedation.  Nine times out of ten, if I (or most of my colleagues) had to pick a benzodiazepine or an antipsychotic, I would usually pick an antipsychotic first despite the black warning. Risperidone & quetiapine are 2 common prescribed antipsychotics. 2 large studies showed quetiapine (aka Seroquel) to be the least risky of this group of medications. At least one other study has noted risperidone (aka Risperdal) may be the least risk and highest efficacy in the elderly with dementia. However, other studies have not confirmed the latter statement. Risperidone is approved for agitation related to dementia in the UK, but not here in the US. While we have made great strides in our field, we don't have all the answers. We need more research & have a lot left to learn.