Fwd: [SSRI-Research] Dangers of Paxil Withdrawal

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[sSRI-Research] Dangers of Paxil Withdrawal

 

Dangers of Paxil Withdrawal

http://www.namiscc.org/News/2002/Summer/PaxilWithdrawal.htm

 

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

www.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. "

 

Brian Reid is a regular contributor to the Health section.

© 2002 The Washington Post Company

Last Updated on 07/21/02 webmaster