Neurontin, a prescription drug, is FDA-approved to help treat epilepsy and shingles pain. However, 90 percent of Neurontin prescriptions are for off-label uses such as treatment of bipolar disorder and a variety of pain syndromes. A growing number of lawsuits focus on an alleged side effect of Neurontin — suicide. The FDA admitted in March that a problem exists, with officials referring to the link between Neurontin and suicides as an “imminent health hazard.”
Pharmaceutical maker Parke-Davis conducted clinical trials on Neurontin’s use as a treatment for bipolar disorder. Studies showed that a placebo was as good as — or worked better than — Neurontin. Even so, the company continued to promote Neurontin as an off-label treatment for bipolar disorder, creating a potential safety risk for patients.
Although it is illegal for pharmaceutical companies to promote drugs for off-label uses, doctors can prescribe drugs for conditions they deem appropriate. Now many current lawsuits are class actions for consumer fraud, in which plaintiffs claim Parke-Davis knew Neurontin could not help them.
Critics say the company was motivated by profits, generating almost $3 billion in annual revenues from Neurontin. “Some of the worst drug disasters in the United States are the result of off-label use,” said Larry Sasich, a pharmacist and research analyst for Public Citizen’s Health Research Group as quoted in the November 2004 issue of Trial. “The tragic part is that with off-label drug use, the patient is participating as an unwitting subject in an uncontrolled clinical trial.”