TUESDAY, Aug. 28, 2001 (HealthDayNews) -- A just-filed lawsuit claims that Paxil, one of the world's best-selling antidepressant drugs, is addictive, a claim the manufacturer strongly denies.
Meanwhile, a former national drug czar says the suit is based on a misunderstanding of what addiction is. But, he adds, Paxil does cause withdrawal problems.
The class-action lawsuit, filed in Los Angeles Aug. 23, charges that Paxil's maker, GlaxoSmithKline, "actively deceived . . . in its labeling and oral communications" that the drug is not addictive and does not cause withdrawal symptoms, according to the Washington, D.C., law firm of Baum, Hedlund, Aristei, Guilford and Schiavo.
The firm filed the complaint on behalf of 35 people, but it says thousands of Paxil users have "suffered from withdrawal reactions and dependency/withdrawal syndrome."
Glaxo spokeswoman Mary Anne Rhyne says: "We've not been served officially as of yet -- though we have certainly read the media reports. So there is no official comment from the company at this time."
But, she adds, the drug is completely safe.
"We don't feel there is any reliable scientific evidence that Paxil is addictive or leads to dependency. There have been 70 million patient treatments since the drug was launched nine years ago. The experience with the patient treatment is that, overwhelmingly, this is a safe and effective treatment," she says.
The law firm doesn't see it that way.
"The complaint alleges that Paxil, in some people, causes severe -- and what's most important, unexpected -- withdrawal symptoms," says attorney Mary Schiavo. "What's interesting is that most people report the same group of symptoms, and that includes jolting electric zaps
dizziness, light-headedness, vertigo, physical manifestations of muscle problems, disturbances in walking, sweating, nausea and flu-like symptoms."
"Yes, we are alleging that the drug is addictive," Schiavo adds. "What we know is that people have gone back on Paxil, and these symptoms have disappeared. People are unable to get off this drug. And what Glaxo is calling this is a recurrence of depression or anxiety or whatever else the patient was being treated for."
In fact, argues former drug czar Dr. Robert DuPont, the lawsuit is confusing addiction with the body's adjustment to a life without Paxil.
"The complaint is based on a misunderstanding of what is an addiction," says DuPont, who was the first director of the National Institute of Drug Abuse during the Nixon and Ford administrations.
DuPont, now president of the Institute for Behavior and Health, adds: "They're confusing addiction and withdrawal, and those are two entirely separate issues."
You can be addicted to a drug, then stop, and have no withdrawal symptoms, he says. "For example, an alcoholic can stop drinking and not have the DTs," he explains. "And many people who have withdrawal symptoms have no addiction."
DuPont also says: "An addiction is made up of two features -- one is continued use of a substance despite problems, and there is no one in this case who would be like that. The other feature of addiction is dishonesty. You cannot be an honest addict -- you must be a liar." In other words, nobody lied in order to get more of the drug as people would do if they were on, say, crack or heroin.
But that doesn't mean there isn't a problem, DuPont adds.
"There is a problem with withdrawal on Paxil, for many people, but not all," he explains. "They do have withdrawal symptoms, and that is a problem. But having said that, the problem with withdrawal is short-term -- it's going to last a few days to a few weeks, and then it's gone. And what's happening is the brain is getting used to not having the medicine anymore. The solution is a gradual dose reduction."
"I do think something will come out of this [class action lawsuit]," DuPont concludes. "What I hope is that patients taking Paxil will not think about this as a scary medicine. What I hope is that when they are going to stop, they do it gradually -- not abruptly."
Schiavo also insists that getting off Paxil causes "distinct withdrawal symptoms."
In fact, she contends, the U.S. Food and Drug Administration forced Glaxo to change the label on the drug. "They added that abrupt discontinuation could cause fairly mild things, and that those events are quite rare and self-limiting, though they didn't describe what self-limiting meant."
First introduced in the United States in 1993, Paxil is a member of the selective serotonin reuptake inhibitor (SSRIs) family of antidepressants, which also includes the well-known Prozac and Zoloft. Depression and anxiety may be caused by a decreased number of brain messenger chemicals in the brain -- particularly serotonin, which, among other things, affects mood. Paxil keeps more serotonin circulating in the brain, thereby normalizing the brain's chemistry.
It's approved in the United States for treatment of depression, obsessive-compulsive disorder, social phobia and panic disorder. And it was the world's seventh top-selling drug in 2000, racking up sales of $2.4 billion, according to figures compiled by the prescription drug tracker IMS Health Inc.
This is not the first time Paxil has been in legal hot water, Schiavo notes. The family of a man who took the drug was awarded $6.4 million this summer after he murdered his wife, daughter and granddaughter and then committed suicide. The family said the tragedy was caused by a reaction to the drug. Glaxo is appealing the case.
What To Do: For more on Paxil, see GlaxoSmithKline. And for more on the class action complaint, see Baum, Hedlund, Aristei, Guilford and Schiavo.
