On January 31, 2008, the FDA issued a warning to Health Care Professionals of an “increased risk of patients having suicidal thoughts and behaviours as a result of taking antiepileptic drugs for epilepsy, bipolar disorder, migraines, and other conditions.”
Such warning was based upon data collected by the FDA which showed that upon review of placebo controlled studies of eleven antiepileptic drugs, “patients who took them had two times the risk of suicidal thoughts and behaviours (suicidality) of patients who took placebo only (0.43 versus 0.22 per cent).”
In 1994, Gabapentin, (also marketed as “Neurontin”) was approved by the FDA for the treatment of epilepsy. Neurontin during the next years was actively promoted for off-label and unapproved uses such as pain, neuropathy, restless leg syndrome, depression, and bi-polar disorder.
In fact, on May 16, 2004, Pfizer, Inc., the manufacturer of Neurontin agreed to a settlement of $480 million dollars in both criminal and civil claims, as a result of its off-label promotion of the medication.
On March 21, 2005, the law firm of Finkelstein and Partners submitted a letter to the FDA with approximately 258 reported death cases of individuals that had committed suicide while taking Neurontin. There have been numerous other petitions to the FDA, specifically requesting that a Black Box Warning be placed on the Neurontin.
There are presently hundreds of cases pending before the United States District Court of Massachusetts.
Despite these efforts, the FDA has yet to issue a specific Black Box Warning with respect to Neurontin and the risk of suicidality. In fact, in a recent Amicus brief, the FDA has set forth that its January 31, 2008 Warning “does not constitute a conclusion by the FDA that the drugs subject to the Alert actually cause the adverse event in any particular population or caused a specific adverse event in a particular individual.”