Antipsychotic medications have been prescribed since the mid-1950s. These drugs improved the lives of people with debilitating psychiatric disorders like schizophrenia and bipolar disorder, even though most had some serious side effects. Several decades later, the Food and Drug Administration (FDA) approved a second generation of antipsychotic drugs with fewer side effects called “atypical antipsychotics.” Very shortly, over 90% of antipsychotics prescribed belonged to this second generation. The remainder of this case deals with this second generation of drugs. Prescription of antipsychotics has skyrocketed in the last two decades, despite the fact that the percentage of the US population afflicted with the conditions for which the drugs are approved (schizophrenia, bipolar disorder, and major depressive disorder) has continued to hover around 3%. The increase is attributed to “off-label” prescribing, which allows doctors to prescribe an FDA-approved drug for other purposes, when sufficient evidence supports efficacy, comparative effectiveness, and safety. Off-label prescription of antipsychotics accounts for the vast majority of prescriptions for this class of drugs.
Experts question the dramatic increase in use of these powerful drugs to treat off-label conditions, such as anxiety, attention deficit disorder, disorder, some autism spectrum disorders, insomnia, combat-induced post-traumatic stress disorder, obsessive compulsive disorder, substance abuse, behavioral issues in children, and dementia in the elderly. A few uses are supported by evidence, while many are unsupported by sufficient study. Safety, dosage, duration, method of action, differential age effects, and many more variables have simply not been controlled in rigorous studies.
Of particular concern is the use of antipsychotics in children and the elderly. Many studies document the dramatic increase in off-label antipsychotic prescriptions for children, especially children on Medicaid. Most frequently doctors prescribe these drugs to control disruptive behavior in children. Among the elderly, doctors use the drugs to moderate the behavior of dementia patients and to treat generalized anxiety.
Although demonstrating fewer side effects than the original class of antipsychotics, atypical antipsychotics still have serious side effects, especially with long term use. Extreme and rapid weight gain, irreversible motor conditions like spasms and drug-induced Parkinsonism, sedative effects, and fatigue are among other common side effects. Despite a 2005 FDA warning that these drugs are associated with premature death in the elderly, prescription continues to this population. Drug treatment for many psychological disorders, including off-label use of antipsychotics, has increased for a number of reasons. Primary care physicians often lack the training, time, or comfort level to deal with psychosocial problems, and prescribing a drug is an easy solution. Many health insurance plans favor drug treatment, which is usually less expensive than more labor intensive counseling alternatives. Perverse incentives also influence prescribing behavior. For example, a child taking antipsychotics may be eligible for Social Security Insurance Disability funding, and for increased social and educational services. Although the FDA prohibits advertising off label uses of drugs, drug companies find loopholes to promote the products and create demand with the public and with healthcare providers.
from the 2014 National Ethics Bowl