Date Added: 2008-02-14 06:30:02

Times Union (Albany, NY) (KRT) via NewsEdge Corporation :

Feb. 13--Until his wife took a drug called Neurontin, James Presley never recalled Carol Presley being depressed or having suicidal thoughts in their 21 years of marriage.

James Presley, of Cobleskill, awoke one morning several years ago to find Carol in tears. She asked him for a gun. That's when he saw a glass of Drano on the counter with a straw in it and burn marks on his wife's lips.

Last month, the U.S. Food and Drug Administration released a warning that Neurontin and 10 other anti-epilepsy drugs increased the risk of suicidal thoughts and behaviors. The warning comes three years after the Presleys' lawyer petitioned the FDA to inform the public about suicidal tendencies associated with the drug.

Attorney Andrew Finkelstein, of Finkelstein and Partners in Newburgh, Orange County, represents the Presleys and 350 families of people who killed themselves or attempted suicide after taking Neurontin. Finkelstein's clients include an Albany man who shot himself in the head and survived, and the family of George Hugaboom, a Glenville man who killed himself with an antique pistol while sitting outside in a lawn chair.

The FDA study looked at Neurontin, Lyrica, Depakote, Keppra and several other anti-seizure medications for epilepsy. The drugs also are prescribed for "off-label" uses like pain and psychiatric conditions, including bipolar disorder.

The FDA analyzed 199 clinical trials of the 11 drugs and found that 0.4 percent of people who took them showed suicidal behaviors, compared with 0.2 percent in the placebo group.

Four patients who took one of the anti-epileptic drugs committed suicide, while none of the patients in the placebo group did.

Carol Presley, 43, a substitute teacher, was taking Neurontin for nerve pain in her foot. She survived the suicide attempt but suffered severe burning along her digestive tract and underwent extensive medical treatment. When asked why she tried to kill herself, she said she didn't know.

Carol lived for another three years and died suddenly in October from cardiac arrest. She is survived by two teenage sons.

"I would discourage doctors from prescribing the medicine outside of FDA-approved purposes," said James Presley, a scientist at GE. "I wouldn't want this to happen to other families."

Pfizer, the company that makes Neurontin, pleaded guilty in 2004 to marketing the drug for unapproved uses and was fined $440 million.

A Pfizer spokesman said the company conducted extensive reviews of both Neurontin and Lyrica and "we have identified no evidence of an increased risk of suicide-related events in either product."

Dr. Michael Gruenthal, chief of neurology at Albany Medical Center, said the FDA report lacked detail, but raised some questions about the drugs' risks.

"Our biggest concern is that people may panic and stop taking the medications, which could be dangerous and lead to life-threatening seizures," Gruenthal said.

Most consumers are not aware of the risks, Finkelstein said.

"What is still unknown is whether the FDA is going to require a label change," the lawyer said. "A black box and a clear unadulterated warning I think would have a positive effect."

Finkelstein's first Neurontin trial is scheduled for August.

F. Crowley can be reached at 454-5348 or by e-mail at ccrowley@timesunion.com.

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