Generic Drug Maker Fails to Warn of Permanent Injuries from Antipsychotic Medication

Case Overview

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.

Questions to the Toxicology expert and their responses

Are you familiar with FDA labeling protocols?

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.

About the expert

This expert holds a doctorate degree in toxicology and has been a practicing toxicologist for over 40 years. Board certified by the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, he had published over 35 scientific articles and is a former president of the Mid-Atlantic chapter of the Society of Toxicology. He spent over 30 years as a Director of Toxicology for two major pharmaceutical companies and currently serves as an independent toxicology consultant.

E-001445

Specialties:

Toxicology