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Old 08-27-2002, 12:04 PM   #1
Join Date: Jul 2002
Location: central Ohio
Posts: 219
News Article- Quit Paxil, And Then: Zap!

Quit Paxil, And Then: Zap!
Complaints Surface About Stopping Drug

By Brian Reid
Special to The Washington Post
Tuesday, August 27, 2002; Page HE01

Paxil, the world's best-selling antidepressant, has become the target of growing complaints that stopping the drug causes severe side effects ranging from flu-like symptoms to electric-shock-like sensations in the brain that patients have labeled the "zaps." This marks the first time that one of the new generation of antidepressant medications, often described as non-habit-forming, has been accused of being addictive.

The patient complaints, which previously circulated chiefly on electronic bulletin boards and specialized Web sites, became more public last week when a federal judge in California ordered the drug's maker, GlaxoSmithKline, to pull TV ads that boast the drug is "not habit-forming." The judge later put that ruling, which said the ads may have underplayed the drug's possible role in causing withdrawal symptoms, on hold.

Both Glaxo and the Food and Drug Administration (FDA) have challenged the decision, part of a California court case brought on behalf of Paxil users.

At stake, potentially, is the treatment of thousands of U.S. patients on Paxil, which brought Glaxo almost $3 billion in revenue last year and was prescribed more than 70 million times in the last decade. That growth has been driven in part by an expanding list of uses. Paxil is approved for the treatment of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder and generalized anxiety disorder.

The judge's initial action highlights concerns that have dogged the drug since it was introduced a decade ago. Although Paxil has become a staple of pharmacologic treatment for depression and anxiety, the very chemical attributes that make it a wonder drug for some patients may also contribute to symptoms when the drug is stopped.

A member of a class of drugs known as selective serotonin reuptake inhibitors (or SSRIs), which includes Prozac and Zoloft, Paxil works by ensuring that the chemical serotonin, which the brain sends from one nerve cell to another, reaches its destination. (In depressed individuals, serotonin is often reabsorbed by sender cells before it can be transmitted.) Over the course of treatment, brain cells adapt to the presence of the drug, changing their physical properties.

Paxil, however, breaks down more quickly than Prozac and Zoloft. Once Paxil is stopped, the levels of the drug in the cells drops quickly, say medical experts, triggering the kinds of problems that prompted the lawsuit against Glaxo. One patient involved in the California suit, Pamela Fikter, described the sensation as "like I was going crazy," according to court documents. "I was dizzy, light-headed, uncoordinated. . . . I was so terrified that something very serious must be wrong with me."

Reports of similar ailments in patients who had stopped taking Paxil began showing up in the medical literature within a few years of the drug's 1992 U.S. debut.

By the late 1990s, clinical studies offered evidence that the symptoms associated with discontinuing use of the drug -- ranging from flu-like ailments and nausea to dizziness, insomnia and electric-shock-like sensations in the brain -- appeared more often in patients treated with Paxil than in patients treated with other psychotropic drugs.

That has spawned a network of Web sites and bulletin boards, with names like quitpaxil.org, devoted to spreading information on the side effects. And it prompted Baum, Hedlund, Aristei Guilford & Schiavo, a California law firm that had represented antidepressant users in past suits, to launch legal action last summer claiming that Paxil patients had been misled and asking for punitive damages against Glaxo, the world's second-biggest drug maker.

The evidence from the medical research and the side effect reports submitted to the FDA have convinced experts on both sides of the issue that some patients who stop taking the drug -- especially those who halt it abruptly -- will experience symptoms as the drug washes out of their system.
The 'Withdrawal' Question

But causality is hotly debated. Last December, Glaxo changed Paxil's label, under FDA direction, to include reports of symptoms following discontinuation of the drug. The change reads pointedly that the symptoms "may have no causal relationship to the drug." It also never mentions the word "withdrawal."

Still, the change gave doctors FDA-sanctioned instructions to be on alert for the problem, encouraging physicians to recommend "a gradual reduction in the dose rather than abrupt cessation."

Where disgruntled Paxil patients and Glaxo have parted ways is not on whether the symptoms exist but rather whether the symptoms are the mark of a habit-forming drug or just a mild, expected consequence of treatment. The patients in the lawsuit refer to the side effects as "withdrawal symptoms" that can make stopping the drug disabling. The drug maker refers to the same effects as "discontinuation" symptoms.

A final ruling in favor of the plaintiffs, who are seeking reimbursement for their Paxil prescriptions and for medical treatment in addition to punitive damages, could harm both Glaxo's bottom line and the drug's image.

"Clearly, we disagree with the ruling and we don't believe that the ads were misleading," said Alan Metz, Glaxo's vice president for clinical development. "There is no evidence that Paxil is addictive." The FDA backed the company's position, arguing in a court filing that "FDA scientists that have considered this very issue do not regard [Paxil] to be habit-forming."

Distinguishing between a drug that is addictive and one that has side effects associated with going off it is the key to Glaxo's contention that the drug isn't habit-forming.

The company and the FDA note that other non-addictive drugs, such as steroid treatments and some high-blood-pressure medications called beta blockers, also leave patients at risk of problems when they stop taking the medications. But the FDA says neither those drugs nor Paxil prompts the kind of "drug seeking" behavior associated with addictive drugs like opium or cocaine.

"Patients ask me, 'Is this habit-forming?' I say no," said Fred Goodwin, a professor of psychiatry at George Washington University Medical School and the former head of the mental health branch of the National Institutes of Health. "But if you stop it suddenly, your body isn't going to like it very much."

But other doctors and patients say Glaxo shouldn't dismiss ill effects as common, expected events, even if Paxil users don't act like cocaine addicts. "The way they phrase it, you would think that most of the withdrawal is mild," said Joseph Glenmullen, the Harvard psychiatrist who wrote "Prozac Backlash." "Clearly, this is withdrawal and that's what it should be called. . . . It's like throwing a car that's going 60 miles an hour into reverse. The cells were making adaptation to living with the drug 24 hours a day."

When you get to the end of your rope, tie a knot and hang on.
- Franklin D. Roosevelt

Don't compromise yourself, you are all you've got.
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Old 08-27-2002, 09:18 PM   #2
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Old 08-28-2002, 07:11 AM   #3
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i I am fuming over this........To say a drug does not cause these side effects (which are hard to even describe) such as the ZAPS!!! really makes my blood boil!!! The makers of this drug needs to take em for a while and then try to get off.......This drug not only zaps your brain it doesn't even help with the illness it was prescribed for!!! You HAVE to keep taking this stuff whether you want to or not.....I have ankylosing spondylitis which is made worse by "nerves" so this drug is a double whammy for me.......The side effects are worse than the "nerves" I think the American people have been purposely misled on this drug and something needs to be done to stop it from traumatizing any other folks.......Boy! I could be an advertising agent against this drug paxil and I hope it is taken off the market and the makers penalized!!!!!!!! At 52, you would think I could lead a fairly normal life but this drug has gotten the best of me and I wonder if life is really worth all these problems.....Sometimes I think the only way to get off this drug is to die....
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Old 08-28-2002, 07:50 AM   #4
Join Date: May 2002
Location: Ohio, USA
Posts: 589
Kathy: it does seem like a never ending journey to get off this rollercoaster ride. Please hang in there! You'll make it thru and we can't let another victim of Paxil give in to this!

I can't wait until everyone knows what we've been through and no one can think we're making something out of nothing. I am so darned angry at doctors that still refuse to wake up and hear us, that I could just spit.

By the way... how is everything in North Carolina? I used to live there (Fayetteville for 15yrs, Wilmington for 3) and I loved it. I miss it a lot. Topsail Island.... my favorite place in the world.

What is ankylosing spondylitis ?
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