Prozac is linked to child suicide in US

[Guest guest]

Prozac is linked to child suicide in US

By Jeremy Laurance and David Usborne in New York

15 September 2004

http://news.independent.co.uk/uk/health_medical/story.jsp?story=561811

 

The Government came under pressure yesterday to ban the use of the

antidepressant drug Prozac in children after US regulators warned that it

could increase the risk of suicide.

 

Prozac is the only antidepressant that doctors can prescribe to children in

Britain following a safety review last year. The drug was singled out by the

UK Medicines and Healthcare Products Regulatory Authority (MHRA) as the only

one of the modern generation of antidepressants that was effective and safe

in children. All others were banned for children last December.

 

But US regulators claim there is nothing to distinguish the drugs, known as

selective serotonin uptake inhibitors (SSRIs) and all are risky in children.

" I think we now all believe that there is an increase in suicidal thinking

and action that is consistent across all the drugs, " Robert Temple, the

director of the Food and Drug Administration (FDA) office of medical policy,

said on Monday.

 

He was speaking at the first day of hearings in Washington on whether

antidepressants should have tougher warning labels. An advisory committee of

the FDA was expected to announce the new curbs last night after two days of

hearings. The curbs are likely to involve more explicit labelling to

discourage their distribution to young people, or an outright ban.

 

Disclosure of the US authorities' view that there were problems with Prozac

alarmed psychiatrists in Britain. Tim Kendall, head of research at the Royal

College of Psychiatrists, who published a survey of research on

antidepressants in children earlier this year, said: " We got all the

published trials and the unpublished material from the MHRA and we couldn't

find that. If the FDA has come up with something [in relation to Prozac] it

suggests the MHRA didn't have the full set [of unpublished trials], which in

itself is worrying. "

 

Mike Shooter, president of the Royal College and a child psychiatrist, said:

" It is outrageous that any information about efficacy or side effects should

be kept from psychiatrists, patients or their carers. If we are now getting

information that both the efficacy has been overblown and the side effects

underplayed then basically we have all been cheated. It undermines the

therapeutic relationship. "

 

The FDA analysis found the risk of suicide among patients given such pills

was small. Only two or three out of 100 became suicidal compared to children

who were given placebos. Of the few who did become suicidal, none took their

lives.

 

Relative risks of suicidal behaviour were highest among young people taking

Luvox, Effexor and Paxil and lower among those taking Celexa, Zoloft and

Prozac. The US is now playing catch-up with Britain, and the delay in the

FDA acknowledging the link between the drugs and suicidal thoughts has

angered parents who have lost children while on treatment. " Why haven't

parents been told the truth? " asked Mark Miller, whose 13-year-old son

killed himself after he started treatment with Zoloft.

15 September 2004 15:31

 

http://www.usatoday.com/news/health/2004-09-13-prozac_x.htm

Prozac linked to child suicide risk

By Marilyn Elias, USA TODAY

BETHESDA, Md. — Prozac, the only antidepressant certified as safe for

children, may make kids more suicidal, according to evidence out Monday.

A large new study added to previous research on Prozac shows that kids

taking the drug have about a 50% higher risk of suicidal thoughts and

suicide attempts than those getting placebos, says Robert Temple, director

of the Office of Drug Evaluation at the Food and Drug Administration.

 

Temple spoke at the first day of hearings on potential label changes for

antidepressants taken by more than a million children and teenagers. The

discussion continues today, and an advisory committee could end the day by

asking for tougher warning labels on all antidepressants taken by kids. The

FDA typically follows the advice of its advisory committees.

 

Following a February hearing, the FDA in March asked drug companies to

relabel 10 antidepressants, warning that young patients should be watched

for worsening depression and anxiety. Critics at the time derided that move

as " too little, too late, " considering that, in December, British drug

regulators had advised doctors to prescribe only Prozac for depressed kids.

 

Drugs in question

 

The FDA is reviewing label changes for:

 

Prozac

Zoloft

Paxil

Luvox

Celexa

Lexapro

Wellbutrin

Effexor

Serzone

Remeron.

 

 

Other major antidepressants prescribed for kids already have been found to

raise the risk of suicidal behavior. Prozac had been an exception. " What's

interesting and persuasive is that these studies now all lean the same way, "

Temple says.

 

So far, only Prozac has been found to be effective in children and teens,

although the other drugs, approved for adults, are prescribed to children as

an off-label use.

 

There were no suicides in the antidepressant studies of about 4,600

children. The increased risk for suicidal behavior is small: About two to

three kids in a group of 100 become more suicidal because they're on

antidepressants, says Tarek Hammad, medical reviewer for the FDA.

 

Dozens of parents testified at the hearing that antidepressants had caused

their children to kill themselves — or others. Their claims were " passionate

and plausible, " says psychiatrist Wayne Goodman, chairman of the FDA

advisory panel.

 

But other parents and psychiatrists said the popular pills, such as Zoloft

and Celexa, are saving lives every day.

 

Drug company spokesmen argued that antidepressants are safe. Company studies

show most suicide attempts by children on Zoloft are linked to stress, not

to taking the drug, says Steve Romano of Pfizer Inc., which makes Zoloft.

 

Although antidepressants seem to generate more suicidal behavior, " we can't

forget all those who are protected from suicide by treatment, " Goodman says.

 

There may be a group of kids who are particularly vulnerable to dangerous

effects, but the limited studies so far don't suggest how they can be

identified, FDA officials say.

 

And all the bad publicity on the drugs " is going to put a real damper on

research just when we need more. Now (the drug) industry isn't going to want

to fund more studies, " says Graham Emslie, child psychiatrist at University

of Texas Southwestern Medical Center in Dallas.