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Reconsidering antiepileptic medications as a treatment for bipolar disorder

From the Los Angeles Times:

A study coming out in tomorrow’s edition of Archives of General Psychiatry may prompt doctors and patients to reconsider the merits of using antiepileptic drugs to treat people with bipolar disorder.

Just last year, the U.S. Food and Drug Administration issued an alert that antiepileptic drugs -- such as Neurontin (generic name gabapentin), Lyrica (pregabalin), Topamax (topiramate) and Tegretol (carbamazepine) -- increased the risk of suicidal thoughts and behaviors. That’s particularly important for patients with bipolar disorder, because they already have a higher risk of suicide compared to healthy people.

But the new analysis finds that bipolar people who took one of 11 antiepileptic medications had the same rate of suicide attempts -- 13 per 1,000 patients per year -- as those who didn’t take any drugs for their condition. That rate was slightly lower than for bipolar people who took lithium (18 suicide attempts per 1,000 patients per year). It was also much lower than the rate of suicide attempts among bipolar people in the year before they began taking antiepileptic medications (72 per 1,000 patients per year).

The findings are based on records of 47,918 patients with bipolar disorder who were included in the PharMetrics medical claims database. The study was conducted by researchers from the Center for Health Statistics at the University of Illinois at Chicago and the Columbia University College of Physicians and Surgeons in New York.

Posted: 12/9/2009 9:15:00 AM

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Pfizer Faces First Trial on Neurontin Suicide Claim

From Bloomberg.com:

Pfizer Inc., the world’s biggest drugmaker, goes to trial on claims its epilepsy medication Neurontin increases the risk of suicide, in a case the judge called “very tough” for the plaintiffs to win.

The July 27 trial will be the first of what plaintiffs’ lawyers say are about 1,200 cases. It will show each side the other’s strategy and may help point the way to settlements. The lead attorney for the family of Susan Bulger, 39, who took the drug before hanging herself in 2004, is Mark Lanier, winner of the biggest verdict over Merck & Co.’s painkiller Vioxx.

Pfizer says Bulger’s suicide was unrelated to its medicine and points to what it calls a history of mental disorders and abusing drugs including cocaine. Her past might make it hard for the family to win, said Robert Rabin, a law professor at Stanford University in Palo Alto, California.

“If she was taking other drugs, there’s a question if this particular drug contributed to the suicide,” Rabin said in a phone interview.

The company says Bulger’s life was “fraught with psycho-social stressors, including physical and mental abuse, long-term substance abuse and addiction to cocaine, heroin, Methadone and Oxycontin.”
“Mrs. Bulger attempted suicide multiple times before ever ingesting Neurontin,” Pfizer said in court papers. “Six months before her suicide, Mrs. Bulger was caught buying cocaine on the street,” it said.

Lanier, a Houston lawyer representing the family and about 600 other Neurontin plaintiffs, counters that the drug helped push a “fragile lady” over the edge. He is asking for $250,000 in compensation plus punitive damages.

Lanier also will rely on a December decision by the U.S. Food and Drug Administration to order all makers of epilepsy drugs to add a suicide-risk warning to their labels.

The agency’s reviewers found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of 11 drugs. Pfizer opposed the warning, saying Neurontin was safe and it was unfair to combine data for medicines that work differently.

The judge refused to dismiss the Bulger case and others on alleged failure to warn of Neurontin’s side effects. She rejected Pfizer’s bid to block expert testimony the drug increases the risk of suicide.

“Pfizer believes that the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior,” said Loder, the spokesman.

“The Neurontin label prior to Mrs. Bulger’s death was adequate and appropriate based on the reliable scientific data concerning the medicine, and all pertinent safety information was provided to the FDA,” Loder said.

Posted: 7/28/2009 1:26:00 PM

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