I wished it was only the mind numbness. It is the depressive/suicidal factor that this pill brings.
" On May 17, 2004, Andrew Finkelstein, of the New York law firm of Finkelstein & Partners, submitted a citizen’s petition to the FDA requesting that a black box suicide warning be added to the label and that a Dear Doctor letter be sent out to instructing physicians to be on alert for increased depression in patients taking the drug.
Mr Finkelstein also continued to remind the FDA about the rising number of suicides. In a March 21, 2005, letter to Dr Russell Katz, he wrote in part: “Enclosed you will find two hundred fifty eight MedWatch forms … Each represents a suicide of an American who was on Neurontin when he or she took his or her own life.”
“Many of these suicides likely could have been prevented,” he said, “had both the treating physician and unsuspecting families been armed with full knowledge of the risks of suicide that was known to both the FDA and the manufacturer.”
But as it turns out, the FDA was fully aware of the suicidality risk when Neurontin was recommended for approval in 1992, and Dr Katz oversaw the FDA’s analysis of the clinical data provided to support the New Drug Application.
According to Mr Finkelstein, the evaluation of serious adverse events during the original clinical trials showed the risk of suicide was known and a major concern. In the letter to Dr Katz, he pointed out that an FDA reviewer specifically stated in December, 1992:
Serious adverse events may limit the drug’s widespread usefulness. Depression, while it may not be an infrequent occurrence in the epileptic population, may become worse and require intervention or lead to suicide, as it has resulted in some suicidal attempts during clinical trials.
In fact, in the clinical trials, Neurontin was attributed to four people actually attempting suicide, two more having depression with suicidal ideations, and 22 participants reporting depression so severe it required pharmacologic intervention. Most alarming was that 19 of the 78 participants who reported depression had no prior history of depression.
“Clearly,” Mr Finkelstein told Mr Katz, “the FDA did not approve this drug with any expectation of use beyond the approved indication.”
