Fwd: [drugawareness] #2-Suicide Side Effect-What parents aren't being told about kid's antidepressant

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Mon, 5 Jan 2004 03:49:11 EST

[drugawareness] #2-Suicide Side Effect-What parents aren't being told

about kid's antidepressant

 

 

 

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

 

Continued:

 

A Suicide Side Effect?

 

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

 

Rob Waters

Sunday, January 4, 2004

 

 

 

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 patients

who 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