Neurontin Should Have Had Depression Warning, Neurologist SaysJun 20, 2008 | Parker Waichman LLP
A British neurologist says he advised the maker of Neurontin to include a warning on its label about its potential to cause depression and aggression, but he was ignored. According to The Wall Street Journal, the neurologist, Michael R. Trimble from the University of London, was testifying at a hearing to decide whether civil cases brought against Pfizer alleging suicides linked to Neurontin can proceed.
Neurontin was approved for sale in the mid-1990s as a treatment for epileptic seizures. While Neurontin is approved for the treatment of epilepsy, it has been used "off-label" to treat a wide range of other conditions, including bipolar disorder, ADHD and Migraines.
Earlier this month, the U.S. Food & Drug Administration (FDA) directed the makers of 11 epilepsy drugs, including Neurontin, to add new warnings to their labels about the drugs' potential to cause suicidal thoughts and behavior. The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.
According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.
According to The Wall Street Journal, Dr. Trimble testified that in 1995 and 1996, he was hired to write two confidential reports for Parke-Davis -- now a unit of Pfizer -- because the company "was concerned about psychosis" as a potential side effect of Neurontin. Dr. Trimble said he was unable to find a link to psychosis, but did find one between the drug and depression and aggression. For the 1996 report, Dr. Trimble analyzed nine patients who had no previous symptoms of the side effects. Five of those patients exhibited depression and aggression after they had begun taking Neurontin. Dr. Trimble said he recommended to the company that the drug "should carry some kind of warning" for susceptible patients.
Dr. Trimble's testimony was part of a hearing that was jointly held by judges for U.S. District Court in Boston and a New York state court who are hearing similar cases. According to The Wall Street Journal, various lawsuits have been consolidated in the federal court in which plaintiffs allege more than 100 suicides were connected to Neurontin usage.