[WithdrawalRecovery] Kid's Antidepressants- What Parents Aren't Being Told

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A Suicide Side Effect?

What parents aren't being told about their kids' antidepressants

Rob Waters

Sunday, January 4, 2004

©2004 San Francisco Chronicle

 

URL:

http://sfgate.com/article.cgi?file=/c/a/2004/01/04/CM118608.DTL

 

* Names and identifying details have been changed.

 

For 16-year-old Angela Reich*, 2002 was a year of hell. First, the

Palo Alto teenager was diagnosed with a rare form of highly

aggressive cancer. Then she went through months of debilitating

chemotherapy that made her nauseous, caused her hair to fall out and

kept her in bed for much of her last year of high school. She

handled it all with unflappable poise and good humor until

it seemed she was out of the woods. But the worst began when she

started taking the antidepressant Paxil.

 

" Angela had been just pushing through and pushing through, " says her

mother, Sara.* " She mustered all her strength and courage to face

the chemo and to be sick all the time. " By the end of the summer,

with the most intense part of her treatment behind her, she was worn

out and discouraged. " She started to feel overwhelmed and depressed. "

 

She began seeing a therapist and talked openly about her feelings.

But after a few weeks her depression had not lifted, and Angela

asked about going on antidepressants.

 

It took six weeks for the Reich's insurance company to approve a

psychiatrist, and by then Angela was in a deep funk. " She was not

wanting to get out of bed in the morning, " Reich recalls. " She

couldn't do her homework. She said it felt terrible to live like

this, but then she would say, 'I don't want to die, I don't want to

hurt myself.' I remember sitting across from her at the kitchen

table and tears pouring from her eyes and her saying 'This is so

hard.' "

 

The psychiatrist prescribed Paxil, a selective serotonin reuptake

inhibitor (SSRI) similar to its famous predecessor, Prozac. On a

dose of 5, then 10, then 15 milligrams a day, Angela soon started

feeling better. Five weeks after she began taking the medication,

Angela and her mother met with the psychiatrist, who suggested

another boost in dosage. " He said she's doing well now; she could be

doing even better on 20 milligrams, " Reich remembers. She was

hesitant, but Angela wanted her old life back and thought it

made sense to try. The next day, she started on the higher dose.

 

Restless Legs, Sleepless Nights

 

Within days, Reich says, her daughter was acting strangely. The

first change was Angela couldn't keep her leg still. " She'd be

sitting in a chair and her knee would be jerking up and down. " She

became irritable and had more trouble sleeping. Her parents would

ask about her restless, jerking leg and she would snap at them to

leave her alone.

 

When Reich left on a business trip, Angela called her three or four

times a day and begged her to come home early. When she returned,

Angela " burst in my room and hugged me, " Reich says. " She kept

saying, 'Mommy, I'm so glad you're home.' She was scared, like she

couldn't cope. She said she dreaded going to bed because she had so

much trouble sleeping. She'd lay there thinking and her thoughts got

darker and became unbearable. "

 

That night, Reich shared her daughter's bed but Angela slept little

and was still wound up in the morning. When her mother tried to get

her ready for a piano lesson, she said she wasn't going. " She looked

funny and had a weird smile on her face, " Reich remembers. " I knew

something was wrong. I looked around the room and saw some pill

bottles. I asked if she took any pills and she said 'Yes.' "

 

Under questioning, Angela told her mother she had taken four tablets

of the sleeping pill Ativan. Then Angela ran to the bathroom, locked

the door, and started going through pill bottles. Her father, Jim,

smashed the door open and snatched a bottle of Benadryl from her

hands. She ran to her purse, seized a bottle of Tylenol and began

shoving pills in her mouth. Her mother grabbed her, pinned her arms,

and marched her to the car, as Angela's younger brother watched.

 

Reich drove straight to a nearby hospital. One block from the house,

Angela turned to her mother. " She said 'Mom, I don't know why I did

that. It was like something took me over.' And I said 'I know, it

wasn't like you. But I will keep you safe.' "

 

At the emergency room, the staff administered charcoal to absorb the

drugs, then transferred Angela to a psychiatric hospital. The next

day, the hospital psychiatrist called Reich. " He told me it was a

drug-induced suicide attempt, " she said, related to the increased

dosage of Paxil.

 

Neither Angela, Sara nor her husband, Jim, an internal medicine

doctor, knew Paxil might carry a risk of triggering suicidal

thoughts or actions. Aside from a generic statement that depressed

people are more likely to attempt suicide, there is no mention of

such a risk in Paxil's prescribing information.

 

England Acts, United States Follows

 

The risk Paxil may pose to children and teenagers burst into the

news this summer, when British regulators issued a warning urging

doctors not to prescribe the drug to children. They were acting on

new data presented to United States and British authorities showing

that among 1,100 children enrolled in clinical trials of Paxil,

those taking the drug were nearly three times as likely to consider

or attempt suicide as children taking placebos. " There is an

increase in the rate of self-harm and potentially suicidal behavior

in this age group, " said a statement from the British Medicines and

Healthcare Products Regulatory Agency (MHRA). " It has become

clear that the benefits (of Paxil) in children for the treatment of

depressive illness do not outweigh these risks. "

 

Nine days later, the FDA issued a similar warning and announced that

it would conduct a detailed review of pediatric trials of Paxil, a

review soon broadened to include seven other antidepressants,

including top sellers Prozac, Zoloft and Effexor. In August, Wyeth

Pharmaceuticals warned doctors that its drug, Effexor, triggered

hostile behavior or suicidal thinking in children at twice the rate

as the sugar pills taken as placebos.

 

Then, last month, the MHRA announced that it was urging doctors to

stop prescribing a group of six antidepressants, including Paxil,

Zoloft and Effexor because they caused an increase in suicidal

thoughts and actions. " These products should not be prescribed as

new therapy for patients under 18 years of age with depressive

illness, " wrote Gordon Duff, chairman of the MHRA's Committee on

Safety of Medicines, in a " Dear colleague " letter to British

physicians.

 

Prozac, the only SSRI approved for use in depressed children, was not

included in the new warning. The British review did not find a

significant increase in the risk of suicide-related events among

children taking the drug.

 

The British and American warnings were a stunning turnaround that

left thousands of parents whose children are using the drugs

wondering whether their children were at risk. But it was also long-

sought vindication for a small group of researchers, family members

and lawyers who have been arguing for years that antidepressants

cause some people to become violently unhinged. They say they've

been frustrated in getting this word out to the public, in large

part because of the FDA's unwillingness to confront and control the

drugmakers.

 

The FDA's warning about a possible suicide risk from Paxil left Sara

and Jim Reich feeling furious, betrayed, and ready to sue. " Had I

known there was a threefold increased risk of suicide among kids

taking Paxil, I would not have allowed my daughter to go on that

drug, " said Jim. In fact, Jim has prescribed the drug himself and is

outraged that the Physician's Desk Reference, or PDR - the drug

bible for doctors, based on FDA-approved prescribing information -

says nothing about Paxil's suicide risk.

 

The British and American warnings also raised some troubling

questions: How did drugs that have been widely promoted as nearly

risk-free, and that are commonly prescribed by pediatricians and

child psychiatrists, come to be seen as potentially dangerous? What

should parents whose children are taking them do about it? And just

how effective are these drugs that can sometimes cause such serious

problems?

 

An Uncontrolled Experiment

 

Since 1987, when Prozac became the first SSRI on the market,

America's love affair with antidepressants has worked its way down

the age ladder. Between 1987 and 1996, the use of antidepressants

and other psychotropic medications by children and adolescents

tripled, with most of that increase occurring after 1991, according

to a recent study in the Archives of Pediatric and Adolescent

Medicine. By 1996, the study found, 6 percent of American

children and teenagers were taking psychotropic medications, one-

third of which were antidepressants.

 

Biological solutions to behavioral problems were becoming

increasingly acceptable, even fashionable. " I think there's been a

revolution in the way people think about behavior, " says Lawrence

Diller, a behavioral pediatrician in Walnut Creek. " The idea that

children's behavior is the product primarily of their genetics and

biochemistry was promoted by American psychiatry and hijacked by the

drug industry. It's simply become more acceptable to see behavior as

a reflection of an imbalance in chemistry rather than an imbalance

in life. "

 

The phenomenal growth in antidepressants prescribed to children

leaves many doctors and therapists uneasy. Diller, who has written

about his misgivings in two books ( " Running on Ritalin " and " Should

I Medicate My Child? " ), cautiously prescribes antidepressants to

some children, but says the new data about a possible link to

suicide is making both him and some parents think twice. " It hasn't

caused me to stop using SSRIs, particularly in teenagers, but I

think it's another reminder that our information is incomplete. "

 

To understand how we got here, it's important to know a bit about

the drug-approval process. When a drug company applies to the FDA

for approval to sell a medication, it must demonstrate that the drug

is safe and effective for a particular population, such as adults,

and a specific condition, such as depression. Once the drug has been

cleared by the FDA and is on the market, doctors are free to

prescribe it to anyone for any reason. " Off-label " prescribing, is

quite common; the only real restriction is that drug companies

cannot market drugs to unapproved groups. From 1987, when Prozac was

first approved for adults, until early last year, when Prozac

became the first SSRI approved for use in depressed children 7 and

older, all antidepressants used by depressed children were

prescribed off-label.

 

The widespread use of antidepressants by children, critics say,

amounts to an uncontrolled national experiment. The prescribing

physicians are often pediatricians or family doctors with little or

no training in psychopharmacology. The drugs are frequently given in

the absence of therapy or other interventions. The subjects of the

experiment - children - are too young to give meaningful consent.

There is little understanding of the long-term effect these

medications have on the architecture of children's developing

brains. And the evidence that the drugs are effective is less

than impressive.

 

When Prozac was approved for depressed children last year, it was on

the strength of two controlled trials. One, published in 1997 in the

Archives of General Psychiatry, found that after eight weeks, 56

percent of kids taking Prozac showed some improvement, according to

the clinicians who evaluated them, compared with 33 percent of the

kids in the placebo group. But 69 percent of the kids taking Prozac

still had significant symptoms of depression. Clinical trials of

Paxil, Zoloft and Effexor found those drugs to be no more effective

than placebos in treating depressed children.

 

Perhaps the most notable finding from clinical trials of

antidepressants is how many children respond well to placebos - as

many as 59 percent in some studies. This high placebo response rate

is a common finding in pediatric drug trials, in which children are

generally seen once or twice a week by clinicians, says David Healy,

an internationally known psychopharmacologist from the University of

Wales College of Medicine who has emerged as a prominent critic of

drug company practices. " This suggests that simple support can help

children in many cases, " Healy says.

 

SSRIs: Cleaner and Safer?

 

In the years since 1987, SSRIs have developed a reputation for being

largely free of serious side effects, vastly improved over the older

generation of so-called tricyclic antidepressants. In some respects,

this is true: Distressed patients who attempt to kill themselves by

overdosing are unlikely to succeed; they can usually tolerate the

pills. And patients taking tricyclics are more likely to suffer from

constipation, urinary retention, blurred vision and dry mouth.

 

But SSRIs cause sexual problems at fairly high rates, as well as

insominia, nausea, dizziness and other side effects. Studies also

have not found them to be more effective than the older pills at

relieving symptoms of depression. " The SSRIs have sold themselves

very heavily as safe and clean drugs compared to the old

antidepressants, " says Healy. " Well, it's not clear that they're

safer, and it's not clear that they cause fewer side effects. "

 

One side effect of SSRIs, recognized for at least 15 years, is a

sensation called akathisia, a restless agitation that ranges from

jitteriness to a sensation described by some people as " jumping out

of their skin. " Healy believes akathisia is the principal trigger

for impulsive violence in some people taking SSRIs. " They became

anxious, agitated, terrified, unable to sleep at night and

restless, " he says - the symptoms that plagued Angela Reich.

 

There have long been signs that SSRIs sometimes cause these

reactions, which drug manufacturers have tried mightily, and largely

successfully, to keep out of the public eye and off the labels. This

issue first arose a couple years after Prozac went on the market,

amid a raft of media reports about grisly acts of murder and

suicide. The most notorious event took place in 1989, when Joseph

Wesbecker went on a shooting frenzy, killing nine fellow workers of

a Louisville, Ky., printing plant before turning his gun on himself.

Wesbecker, who had a history of mental problems, was taking Prozac.

No one could prove Prozac caused his rampage, but by early 1991,

some 350 suicides of Prozac patients had been reported to the FDA,

according to one former FDA official. Those reports, which occurred

outside the context of scientific clinical trials, were dismissed as

anecdotal and sensational by company officials.

 

Harder to dismiss, though, was a study published by Harvard

researcher Martin Teicher and two colleagues in the American Journal

of Psychiatry in 1990 about six patients who developed " violent

suicidal preoccupation " after taking Prozac for two to seven

weeks. " It was also remarkable how violent these thoughts were, " the

authors reported. " Two patients fantasized, for the first time,

about killing themselves with a gun, " they wrote, while one

placed a loaded gun to her head, another had to be restrained to

prevent self- mutilation, and another fantasized about killing

himself in a gas explosion. None of the patients was suicidal when

they started taking Prozac, the researchers reported, and their

fixation with violence and death abated when they stopped.

 

Similar symptoms were noted the next year in a paper in the American

Journal of Child and Adolescent Psychiatry about six children ages

10 to 17 who developed " intense self-injurious ideation or behavior "

while taking Prozac. After three weeks on the drug, one 14-year-old

girl, who had been depressed but never suicidal, began cutting and

otherwise injuring herself. She told hospital staff, " I'm just

waiting for the opportunity to kill myself, " and chanted, " Kill,

kill, kill; die, die die; pain, pain, pain, " according to the paper.

The Yale University authors noted the complexity of reaching

any conclusion about the cause of these events since the children

all had lengthy histories of psychiatric difficulties that put them

at risk for suicide. They also noted that many children taking

Prozac become agitated, restless, and disinhibited and developed

insomnia to boot.

 

A 1998 paper by Roger Lane, a scientist at Pfizer, the maker of

Zoloft, stated that " all SSRIs have the rare potential to cause

akathisia. " In its most extreme form, Lane wrote, patients may feel

that " death is a welcome result. "

 

Lane also warned that akathisia can sometimes be mistaken for

worsening depression, prompting some doctors to increase the dosage -

and the danger. Healy agrees. " [Doctors] have been educated to

think that SSRIs take four, five, six weeks to work, " he says. " But

they can cause problems long before that. "

 

In response to the Teicher paper and the growing media furor

connecting Prozac to acts of violence and suicide, the FDA in

September 1991 convened an extraordinary special hearing of its

Psychopharmacological Drugs Advisory Committee. Speakers told of

family members who committed suicide or homicide while on Prozac and

begged agency officials to ban or restrict the drug. But

representatives of Eli Lilly, maker of the blockbuster drug, backed

by FDA and academic researchers, argued that suicide is an inherent

risk among depressed patients. The Lilly officials presented figures

from the company's clinical trials database suggesting that people

on Prozac were at no greater risk of suicide than people taking

placebos.

 

Committee members voted unanimously in Lilly's favor, and Prozac

remained on the market. No warning that the drug might induce

violent or suicidal urges in some people was added to its label.

 

'Cooking the Books'

 

The Prozac suicide controversy, and the huge number of suicide

reports that were streaming into the agency, reverberated inside the

FDA, where two other SSRIs, Paxil and Zoloft, were being considered

for approval. The FDA medical officer charged with reviewing Paxil's

safety and efficacy data was Martin Brecher, now an executive with

the British pharmaceutical company Astra Zeneca. " The reports of

successful suicide were coming in in bunches, " he said in a recent

deposition. " It was extraordinary, especially in comparison

to other annual reports where, you know, you had 20 reports of a

cold and maybe two reports of some liver enzyme elevations and here

you are with 20 deaths in a report. "

 

Because Paxil and Zoloft were members of the same chemical class as

Prozac, the FDA asked officials at SmithKline Beecham (the

predecessor to GlaxoSmithKline) and Pfizer, Zoloft's maker, to

submit reviews on the drugs' effect on suicidal behavior of

patients. Brecher called Thomas Donnelly, a SmithKline Beecham

executive, and asked him to prepare such a report. In an internal

company memo uncovered in a lawsuit, Donnelly described his

conversation with Brecher, noting that the FDA " does not see it as a

real issue but rather as a public relations problem. "

 

What happened next is controversial. Critics charge that the company

manipulated data to diminish the apparent suicide risk among Paxil

users and submitted it to the agency. One of the harshest critics is

an unlikely plaintiff's attorney in San Rafael, a self described

conservative Republican and retired Navy officer named Don Farber.

 

Farber, who has spent the better part of the past five years suing

Glaxo-SmithKline and other drug companies, is one of a handful of

lawyers handling such cases. His first case involved a San Jose man,

Reynaldo Lacuzong, who, in 1996, drowned his two children and

himself in a bathtub three days after he began taking Paxil. After

the suit was filed, GlaxoSmithKline and the surviving Lacuzong

family resolved the case with an undisclosed settlement.

 

The same thing has happened in dozens of other cases of alleged SSRI-

induced suicide or violence; few cases ever go to jury. In June 2001,

however, a case did. Three years earlier, Donald Schell, a 60-year-

old Wyoming man, killed his wife, daughter and granddaughter three

hours after taking two tablets of Paxil given to him as samples by

his internist. Surviving family members sued GlaxoSmithKline, and

the jury awarded them $6.4 million for the wrongful deaths of their

relatives.

 

" [The company] knew there was a small group at risk and Don Schell

was one of those vulnerable people, " the family's attorney, Andy

Vickery told the jury. Farber makes the same argument: Drug

companies have an obligation to warn doctors and patients that these

drugs can pose a threat to some people.

 

" If there was a warning that said 'Caution: this drug may cause

suicide in some people,' then doctors are going to know about it, "

Farber says.

 

Instead of warning people, Farber charges, Glaxo-SmithKline tried to

hide the true numbers. " They cooked the books, " says Farber during a

recent interview. " They cheated on the results. And the FDA is part

of this. "

 

Farber says the company manipulated the figures. Documents obtained

by The Chronicle show that in its initial application to the FDA,

the company reported that out of 2,963 adults taking Paxil during

clinical trials in the United States or other countries, seven

patients killed themselves and 42 attempted suicide. But in a review

submitted in April 1991, in response to Brecher's request, the seven

suicides had dropped to five and the 42 attempts had gone down to 40.

 

At the same time, the number of attempted suicides by patients taking

placebos doubled from three to six in the later review. The 1991

review also acknowledges that two suicides and two suicide attempts

charged to placebo occurred during a one-week " washout " period that

came before the start of the study. During that period, subjects

were taken off any drugs they had been using to get the drugs out of

their system. Experts say it is inappropriate to count events during

the run-in period as placebo events.

 

Company officials admit there were errors made in reports filed with

the FDA, but deny any attempt to mislead. " There were unfortunately

some inconsistencies in how the data on suicide attempts was

presented to FDA, " says GSK spokeswoman Mary Anne Rhyne. " When we

became aware of this, we went back and looked at the clinical trial

data again. GSK did not intentionally submit any erroneous or

misleading information to FDA. The suicide data submitted to FDA

explicitly identified when events occurred during the placebo run-in

period. FDA had all this information right from the beginning. "

 

Farber contends that these small shifts in numbers make a big

difference in suicide rates. He claims that a close look at the data

reveals that only one placebo patient out of 554 attempted suicide,

while 49 patients out of 2,963 taking the drug committed or

attempted suicide - a ninefold difference.

 

Rhyne disputes this analysis. " The randomized, placebo-controlled

data shows no statistically significant differences in suicides or

suicide attempts between Paxil and placebo, " she says.

 

Drug Firms and the FDA: Too Close?

 

For its review of all pediatric trials of antidepressants, the FDA is

reanalyzing the data to determine whether reports of suicidal

ideation among children were categorized properly. Critics are

concerned that this reanalysis may minimize the apparent suicide

risk to the benefit of drug companies, and contend that the agency

has a long history of protecting the industry. They point to company

memos, uncovered through legal actions, that reveal a sense of

confidence within the companies that the FDA was on their

side. Memos from Eli Lilly executives described one FDA official,

Paul Leber, as " our defender " and cautioned that faxes should not be

sent to him unless he knew they were coming so he could receive them

personally.

 

Other memos suggest Lilly officials went to great lengths to conceal

any hints that Prozac might trigger suicide. Consider this line from

a 1990 memo to Lilly executive Leigh Thompson written by Claude

Bouchy, a Lilly official in Germany, in response to a request to

change the description of an event from " suicidal ideation "

to " depression. " Bouchy writes: " Hans [a fellow Lilly employee] has

medical problems with these directions and I have great concerns

about it. I do not think I could explain to the BGA [the German

FDA], a judge, to a reporter, or even to my family why we would do

this, especially on the sensitive issue of suicide and suicidal

ideation. "

 

Critics charge that the pro-industry stance of FDA officials

prevented a more thorough examination of the role antidepressants

may play in triggering suicide and violence in some users. They also

charge that many American psychiatric researchers have been

compromised in their ability to look objectively at this issue

because they are so dependent on funding from pharmaceutical

companies.

 

The FDA's Thomas Laughren rejects the notion that his agency is

protecting drugmakers. " The goal here is to get to the truth, " he

says. For the review of pediatric trials of antidepressants now

under way, the agency is bringing in a panel of experts as

judges. " We're taking all the cases and having them reclassified

blindly, " he says. " They'll be looking at all the information

that is relative to the question of suicidality and they will not

know the drug assignment. "

 

As the agency reviews the data, experts will debate a core question:

how to reconcile reports of antidepressants triggering suicidal

behavior with other studies that suggest that these drugs reduce

suicide rates. A paper published in the October Archives of General

Psychiatry found that regions of the country where the use of

antidepressants by children increased the most also tended to have

the greatest drop in suicide rates.

 

Could antidepressants lower the suicide risk in some people while

raising it in others? " It's entirely possible that both things are

true, " says Mark Olfson, a professor of clinical psychiatry at

Columbia University and lead author of the Archives paper.

 

David Healy says the drugs simply have different effects on different

people. " My hunch is that, just as with adults, there is a group of

children who are suited to the pills and do very well on them and an

equally large group of kids who are not. " Among those who don't do

well, Healy says, are some who get much worse.

 

One thing most experts seem to agree on is that patients, especially

children, should be monitored closely for side effects from the day

they start taking the drugs. " They may be more anxious or have

unusual thoughts they've never had before, " Healy says. " They may

think about harming others or themselves. " Healy also suggests

asking children if they've had strange dreams, nightmares or

thoughts since they started taking the drug. " The other thing to

look out for, " he says, " is the opposite effect: Kids who

become absolutely fearless, they just don't feel anxious at all. "

 

Tragedy Strikes

 

On Feb. 2, nearly 13 years after the 1991 Prozac hearings, an FDA

advisory committee will once again hold a hearing about the risk of

suicide by people taking antidepressants, this time focusing on the

risk to children and teenagers. The meeting will come too late to

help 17-year old Julie Woodward of North Wales, Pa.

 

In July, Julie began attending a two-week group therapy program at

nearby Horsham Clinic. A break-up with a boyfriend and conflicts

with her parents had left her feeling withdrawn and in a struggle to

maintain good grades. One condition of attending the program was

taking antidepressants, Tom Woodward says. He and his wife didn't

really like the idea, but were told they were " essential to

treatment " and " very benign. "

 

On day three of the program, Julie began taking 50 milligrams of

Zoloft, and that night came the first signs of unusual behavior.

Julie and her mother had a small dispute, and Julie roughly shoved

her mother, an out-of-character act, Woodward says.

 

During the next few days, Julie became more edgy and withdrawn. On

the evening of day six, she told her parents she wanted to stay home

alone. But when they looked for her later that night, they couldn't

find her. The next day, her father found her body hanging in the

garage. One week after starting on Zoloft, she had taken her life.

 

When the FDA hearing comes, Tom and Kathy Woodward plan to testify,

as do Jennifer Tierney and her daughter, Jame, of Kernerville, N.C.

The Tierneys' story exemplifies another part of the antidepressant

story: withdrawal.

 

All SSRIs have been reported to cause withdrawal problems in some

patientswho stop taking them. Paxil and Effexor, however, seem

especially likely to trigger withdrawal symptoms, probably because

they exit a user's body more rapidly. " Paxil has been linked to more

reports of withdrawal symptoms than any other drug in clinical

history, " says Karen Barth, an attorney with Baum- Hedlund, a Los

Angeles firm that is representing some 3,000 people who have

suffered withdrawal problems on Paxil.

 

Jame Tierney was 14 when she was prescribed Effexor to ease

migraines she'd been suffering from for years. She started with

Effexor and other drugs, but gradually went off the others. She

enjoyed eight good months of reduced headache pain. Then the

migraines worsened and her neurologist doubled the dose. Within two

weeks, her personality began to change. " She became the most angry,

combative, raging child you've ever seen, " says her mother.

" I'd never seen her like this and I had no idea why. "

 

Jame was also unhappy and depressed. " I was hopeless, and I thought

suicide was the only way out, " she recalls. " I had violent thoughts

and tendencies that I'd never felt before. " She contemplated killing

herself and made one attempt to cut her wrists.

 

She remained on 150 milligrams and in a raging misery for a full

year, functioning at school but isolating herself in her room. Then

her mother learned Effexor wasn't a headache drug but an

antidepressant, unapproved for children, which can sometimes cause

serious side effects. Over the objections of the neurologist, Jame

tried to taper off the drug. Her personality quickly returned to

normal, but she suffered terrible withdrawal symptoms - constant

vomiting, headaches, muscle aches and disequilibrium that kept her

out of school for months. Finally, on advice from a California

doctor, she began taking vitamin and enzyme supplements. After six

months, the withdrawal symptoms ended and her headaches are now a

rare event. Her bout with depression, which she experienced only on

Effexor, also came to an end.

 

While Jame was weaning herself from Effexor, Angela Reich was trying

to get off Paxil. Her dose was cut to 15 milligrams a day while she

got through the next round of chemo. She lowered her dosage - to

12.5 mgs, then 10, then 7.5, 5, and 2.5 over four weeks. Finally, on

Jan. 24, she took no Paxil. That's when the side effects began.

 

" She couldn't sit up, she had trouble walking, and she was dizzy, "

Sara recalls. " She couldn't walk straight, and she had this zapping,

this electrical feeling in her arms. "

 

The restless akathisia was gone, but Angela was uncomfortable,

depressed, and irritable - " really irritable, " her mother says. One

night, Angela nearly flipped out. She ran into the living room,

screaming, and started grabbing books off the shelves and heaving

them. " She tore them up and said she hated them, she hated us and

she hated the people around her, " Sara says. " Then she grabbed for

some knives. " Her father restrained her and held her until she

calmed down. But the whole family was shaken. " I started to

feel like 'Oh my God, my kid has gone insane,' " Sara says.

 

Somehow Angela and her family got through the next month, and she

gradually started to feel normal. She went off to college in

September and is doing well, her parents say. Best of all, as this

article was going to press, she got another negative biopsy report

on her cancer.

 

Angela didn't want to talk about her Paxil experiences with a

reporter - " It's just too painful, " her mother explained. But she

did want to join the lawsuit that Baum-Hedlund is pursuing against

GlaxoSmithKline. " She wants to prevent anyone else from going

through this kind of nightmare. She wants to save other people from

suffering like she suffered. "

======================================

 

Berkeley-based writer Rob Waters' articles have appeared in Health,

Parenting, and the Los Angeles Times. He is the co-author of " From

Boys to Men: A Woman's Guide to the Health of Husbands, Partners,

Sons, Fathers, and Brothers, " which will be released in April.

 

©2004 San Francisco Chronicle