FDA Approves Medications For Tardive Dyskinesia
By Ken Duckworth, M.D. | Sep. 28, 2017
Tardive dyskinesia (TD) is a movement disorder that occurs in some people who take first-generation antipsychotics (such as haloperidol, chlorpromazine), and to a lesser degree, second-generation antipsychotics (such as aripiprazole or paliperidone). TD results in repetitive, involuntary movements commonly of the face, lips and limbs.
Movement disorders were first described in people experiencing schizophrenia before the advent of first-generation antipsychotics, but the clear majority of these movement symptoms currently are induced by medicines. TD can be disabling and stressful and it had no FDA-approved treatment—until recently.
Earlier this year, the FDA approved a new medication for the treatment of TD with the trade name Ingrezza and generic name valbenazine. The FDA fast-tracked this medicine’s approval process, given TD’s unmet treatment need. The clinical trial that led to the approval evaluated the movements of 234 individuals with TD who were also diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder. These research subjects were randomly assigned valbenazine or a placebo (a sugar pill). At six weeks, a clear difference emerged in the movement symptoms of the two groups, which led to the approval.
Another medication recently also received FDA-approval for the treatment of TD in adults. With the trade name Austedo and generic name deutetrabenazine, this medication was previously approved (in April 2017) for the treatment of chorea associated with Huntington’s disease. This second-indication approval was based on results from two randomized controlled group studies that found Austedo to be effective and safe in reducing the severity of abnormal involuntary movements associated with TD.
If you have TD, these medications are worth a fresh conversation with your prescriber. In study trials, these medicines appear to be well-tolerated, though as with most treatments, there are common and serious side effects (usually for people with heart rhythm issues).
The clinical focus for TD to date has been largely on prevention, which hasn’t very successful given its prevalence. Doctors assess TD symptoms with the Abnormal Involuntary Movement Scale (AIMS) scale. This should be performed on a regular basis (typically every 6 months). The AIMS exam is an assessment of a person for movements that could suggest TD; if TD is suspected, a discussion about lowering medication dosage or switching medication to one with less risk is typically advised.
TD can be avoided in some cases, but with long-term use of the medicine (tardy or emerging over time), the risks are increased. It’s hard to predict who will develop TD, but we do know that African-American, Asian-American, people with diabetes and individuals over 55 are at a greater risk. Many people take antipsychotics for decades, so the risk of developing TD is real and needs to be weighed against the benefits for symptom reduction and alternative treatments.
I have felt a bit helpless in the past when I see people who experience TD. We didn’t have any treatment options approved by the FDA. But now we have two new tools and I look forward to learning more about these medications from my patients’ experiences and scientific literature.
Ken Duckworth is medical director at NAMI.
A Short History of Tardive Dyskinesia: 65 Years of Drug-Induced Brain Damage That Rolls On and On By
November 22, 2020On November 15, Mad in America published a report on the marketing of two new drugs for tardive dyskinesia (TD), Ingrezza and Austedo, which cost up to $7000 per month and are being touted as “breakthrough medications.” The report provided an in-depth look at the financial influences present in their development and marketing, and told of how these expensive new medications are really “me-too” compounds, with little benefit over an existing generic used to treat TD symptoms.
Given that TD is a disorder caused by antipsychotics, there is an obvious outrageous element to this story: the pharmaceutical industry is now profiting by developing drugs to treat the harm caused by its own products.
There is another aspect to this story, one that can be dug out from the scientific literature, that needs to be known. TD is regularly presented as a disorder of involuntary movements, and thus a dysfunction of the basal ganglia. But this common conception of TD obscures a more devastating truth: TD should be understood as drug-induced brain damage that leads to a global decline in brain function. The motor dysfunction is often accompanied by an increase in psychotic symptoms, a decline in cognitive function, and an increased risk of early death.
Moreover, while the new drugs may reduce the visible manifestations of TD—the tics, spasms, and other motor abnormalities—they do nothing to repair the brain damage caused by antipsychotics. Indeed, an examination of the “mechanism of action” of the TD drugs reveals that they can be expected to worsen brain function over time. These drugs impair the normal functioning of multiple neuronal pathways in the brain.
Read the full article here: www.madinamerica.com/2020/11/tardive-dyskinesia-brain-damage/