On April 11, 2017, the FDA approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.
Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips, and tongue, such as grimacing, sticking out the tongue, and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing. Tardive dyskinesia is a serious side effect sometimes seen in patients who have been treated for long periods with antipsychotic medications, especially the older medications, for chronic conditions, such as schizophrenia and bipolar disorder. Tardive dyskinesia can also occur in patients taking antipsychotic medications for depression and certain medications for gastrointestinal disorders and other conditions. It is unclear why some people who take these medications develop tardive dyskinesia yet others do not.
“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”
Ingrezza may cause serious side effects including sleepiness and heart rhythm problems (QT prolongation). Its use should be avoided in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval. Those taking Ingrezza should not drive or operate heavy machinery or do other dangerous activities until it is known how the drug affects them.
See the FDA Announcement
See also Medical Law Perspectives, March 2015 Report: Post-Traumatic Stress Disorder: Diagnosis and Treatment Failures
See also Medical Law Perspectives, December 2014 Report: Beyond the Holiday Blues: When Depression Leads to Liability
See also Medical Law Perspectives, August 2014 Report: Epilepsy and Seizure Disorders: Malpractice in Diagnosis and Treatment
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication