The last dinner Wendy Dolin had with her husband, Stewart, he was so agitated that he was jiggling his leg under the table and could barely sit still. He had recently started a new antidepressant but still felt very anxious. “I don’t get it, Wen,” he said.
The next day, Mr. Dolin, a 57-year-old Chicago lawyer, paced up and down a train platform for several minutes and then threw himself in front of an oncoming train.
Ms. Dolin soon became convinced that the drug her husband had started taking five days before his death — paroxetine, the generic form of Paxil — played a role in his suicide by triggering a side effect called akathisia, a state of acute physical and psychological agitation. Sufferers have described feeling as if they were “jumping out of their skin.”
The distress of akathisia may explain the heightened risk of suicide in some patients, some psychiatrists believe. The symptoms are so distressing, a drug company scientist wrote in the Journal of Psychopharmacology, that patients may feel “death is a welcome result.”
Ms. Dolin sued the original manufacturer of Paxil, GlaxoSmithKline, claiming the company had not sufficiently warned of the risks associated with the drug. In April, a jury awarded Ms. Dolin $3 million in damages.
The case is a rare instance in which a lawsuit over a suicide involving antidepressants actually went to trial; many such cases are either dismissed or settled out of court, said Brent Wisner, of the law firm Baum Hedlund Aristei Goldman, which represented Ms. Dolin.
The verdict is also unusual because Glaxo, which has asked the court to overturn the verdict or to grant a new trial, no longer sells Paxil in the United States and did not manufacture the generic form of the medication Mr. Dolin was taking. The company argues that it should not be held liable for a pill it did not make.
Concerns about safety have long dogged antidepressants, though many doctors and patients consider the medications lifesavers.
Ever since they were linked to an increase in suicidal behaviors in young people more than a decade ago, all antidepressants, including Paxil, have carried a “black box” warning label, reviewed and approved by the Food and Drug Administration, saying that they increase the risk of suicidal thinking and behavior in children, teens and young adults under age 25.
The warning labels also stipulate that the suicide risk has not been seen in short-term studies in anyone over age 24, but urges close monitoring of all patients initiating drug treatment.
“The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm or suicidal thinking in adult populations,” Frances DeFranco, a company spokeswoman, said in an email. “Any suicide is a tragedy, and a reminder that depression and other mental illnesses can be fatal.”
Ms. Dolin’s lawsuit, however, has lifted the curtain on data from early clinical trials of Paxil, renewing concerns that older adults, who use antidepressants in far greater numbers than young people, may also be at greater risk of self-harm when taking the drugs.
The documents indicate that several suicides and suicide attempts in early clinical trials that were attributed to patients on a placebo — and which made Paxil look safer by comparison — should not have been counted, and that an F.D.A. reviewer later told the company as much. Glaxo eventually reanalyzed its data, and in 2006 enhanced the warning on Paxil, cautioning that among adults of all ages with major depressive disorder, “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo” — 6.7 times higher.
But that label was replaced a year later, in June 2007, by the F.D.A.-mandated warning now carried on all antidepressants, which says only that the increased risk has been seen among people under age 25. [...]
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