This case involves warning lables that were affixed to a popular antipsychotic medicataion and its generic counterparts. The drug in question was used to treat schizophrenia, as well as a number of other psychiatric disorders, under an established brand name for several years. Eventually, it was discovered that using the drug for an extended period of time left patients with a greatly increased risk of tardive dyskinesia, a neurological disorder characterized by involinatry and repetitive movements. As a result, the medication recieved an additional warning lable indicating that the drug should not be used for an extended period of time. However, while the name brand version of the drug carried the new warning label, the leading generic version of the medication did not. As a result, several individuals contracted tardive dyskinesia after taking the generic version of the drug for an extended period of time. It was alleged that the manufacturer of the generic drug failed to warn patients of the risks of long-term use.
Question(s) For Expert Witness
- 1. Are you familiar with FDA labeling protocols?
Expert Witness Response E-001445
Tardive dyskinesia is a serious adverse effect that might occur during therapy with antipsychotic drugs or drugs that might cause a defect in neurotransmission. This condition often is irreversible, and it is not surprising that a patient would be severely disabled after therapy for 5 years. The generic version of the drug should have carried the warning label as to the possibility of developing tardive dyskinesia, given the severity and permanence of the side effect as well as the fact that the name-brand version of the drug had been relabeled to indicate the danger.