What’s All the Fuss about Antipsychotic Use
Before a prescription drug manufacturer can promote a medication for a specific indication they must conduct extensive clinical trials demonstrating safety and effectiveness. The FDA (Food and Drug Administration) then reviews the data and approves an indication if warranted. While the FDA controls approval of medications in this country, they do not regulate their prescribing. If a drug is used for an unapproved indication then it is referred to as “off label” use. In the United States, greater than 1 out of 5 medications are prescribed for an off label use.
Off label use tends to evolve over time as a growing number of prescribers gain knowledge of potential medication benefits either through their own practice, that of their peers or through journal reports. The expense associated with conducting clinical trials for FDA drug approval is a barrier to manufacturers seeking official indications for use.
Many of the medications commonly used in our facilities do not have FDA approval for the indication prescribed. Examples of this would include carbidopa/levodopa (Sinemet) for restless leg syndrome, mirtazapine (Remeron) for appetite stimulation, trazodone (Desyrel) for insomnia and antipsychotics such as risperidone (Risperdal), quetiapine (Seroquel) and olanzapine (Zyprexa) for behavioral and psychotic symptoms of dementia (BPSD).
In the case of antipsychotic use for dementia related conditions there have been attempts by the major drug manufacturers to gain FDA approval for this indication. However, these clinical trials did not demonstrate significant benefit in the majority of patients and their approval was denied. One thing that these clinical trials did demonstrate was that there was an increased risk of death associated with their use in individuals with dementia. This risk has been estimated at a 1.6-1.7 time greater risk of death than individuals with dementia not receiving antipsychotics. More recent studies conducted within the VA system have suggested an even higher risk. These deaths are most frequently associated with cardiovascular or respiratory complications. Because of this significant risk, the FDA has mandated that all antipsychotics carry a “Black Box Warning” if used for BPSD.
It is because of the significant risk associated with antipsychotic use for BPSD, and limited clinical data supporting their benefit, that they come under increased scrutiny during Department of Health survey visits to nursing facilities.
This article was originally published in our monthly issue of From the Front Lines – a monthly publication that shares best practices and medication-related challenges faced by “front line” staff in long-term care and post-acute (LTCPAC) facilities.