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Medical Info : Paxil Judgment -- Do Killings Raise Drug-Safety Questions?
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From: 2many  (Original Message)Sent: 1/8/2004 5:59 AM
Paxil Judgment -- Do Killings Raise Drug-Safety Questions?

By Jeff Levine
WebMD Medical News Archive
 

June 7, 2001 (Washington) -- In the wake of a Cheyenne, Wyo., jury's $8-million dollar award Wednesday, there are new questions being asked about drugs to treat depression. The winners in the historic case are relatives of a man who went on a shooting spree after taking the drug Paxil.

The verdict, the first of its kind in the U.S., followed a lawsuit filed after a violent series of events on Feb. 13, 1998. According to the complaint, 60-year-old Donald Schell took two Paxil tablets, then two days later shot and killed his wife, daughter, granddaughter, and ultimately himself.

The suit charged the drug's manufacturer, now GlaxoSmithKline, with "negligent misrepresentations" for failing to warn patients about the popular antidepressant's potential dangers.

Paul Waldner, a partner in the law firm that represented the plaintiffs, says a key issue here is product liability.

"Whether it be Firestone's tires, Ford Explorers, the addictive qualities of nicotine, or the dangerous portions of drugs [given] to some of the patients -- people in this country are getting fed up with manufacturers not giving the entire truth about their products to consumers," Waldner tells WebMD.

"While we too are saddened by this terrible family tragedy, we do not believe that Paxil was responsible for what happened," said Charles Preuss, lead attorney for GlaxoSmithKline, in a statement. "No valid scientific evidence exists to link Paxil with the events of that day." The company plans to appeal the decision.

Meanwhile, Waldner says his firm has other litigation pending against pharmaceutical companies that make the drugs Prozac (Lilly), Zoloft (Pfizer), as well as GlaxoSmithKine's Paxil. These compounds are known as SSRIs, or selective serotonin reuptake inhibitors, for their ability to maintain the level of a key mood moderator in the brain.

For a small, vulnerable group of people, Waldner claims, the drugs can lead to suicide or violent behavior. Schell, he says, was a kind man with no history of violence until after he took the antidepressant. Ultimately, the jury concluded the drug was 80% responsible for Schell's behavior and that he bore the remaining 20% of the blame himself.

Who might have an adverse reaction to these generally effective drugs?

Ronald Pies, MD, a Boston-based psychiatrist who specializes in treating mood disorders, says he doesn't see a causal link between SSRIs and violence for most patients. However some people who have bipolar disorder, or manic depression, and aren't being properly treated with a mood stabilizer might have a reaction.

"Probably in my experience I've seen a few bipolar patients who have had that kind of experience taking antidepressants, though there's a long, long distance between saying that someone may become manic on one of these agents and saying that somebody can become a homicidal killer," Pies tells WebMD.

Pies suggests that if a person is becoming more agitated on his or her medications, contact his or her doctor. "The message for the general consumer is that these medications are safe and effective for the vast majority of people," he says.

Another question is whether the drug or the underlying disease is the source of the aberrant behavior. James Potash, MD, assistant professor of psychiatry at Johns Hopkins School of Medicine in Baltimore, has treated thousands of patients with SSRIs over the years. He says none of them has ever done anything violent while taking the drugs.

"I've had some patients who've done things like cut their arms, for example, and I'm quite confident that the urge to do that is generated by the depression itself, not by the medication that they're taking to treat it," Potash tells WebMD.

In general, say experts, many more are helped than hurt by SSRIs, and there's no reason to panic if you're currently taking them.

Although the American Psychiatric Association can't comment directly on the lawsuit, the organization does have some general advice for patients worried about their antidepressants.

"Check with their doctor before they make any change. SSRIs have been used safely and effectively with millions of people suffering [from] depression and other conditions," Lloyd Sederer, MD, director of the APA's division of clinical services tells WebMD.


© 2001 WebMD Corporation. All rights reserved.

 

 


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