FDA warns against Paxil for teens and kids

Last Updated Fri, 20 Jun 2003 18:21:34 

WASHINGTON - U.S. regulators warned consumers Friday that no one under
the age of 18 should be using the drug Paxil for depression because the
antidepressant designed for adults may increase their risk of suicide. 

The Food and Drug Administration's warning came a week after the 
British government banned prescribing the drugs to anyone under the age 
of 18. The FDA had asked all makers of adult antidepressants to submit 
research on  how their drugs affect children. 

Paxil's manufacturer, GlaxoSmithKline's studies found that their drug 
did not seem to help pediatric depression. However, the FDA noticed some 
safety concerns and ordered GlaxoSmithKline to analyse the data again. 
The latest analysis found the risk of suicidal thoughts and suicide attempts
to be three times greater among Paxil users, mostly teens, than among 
children given dummy pills, according to the FDA.
               
The FDA said youth using Paxil should not suddenly stop using it. Rather 
they need to ease off the drug under medical supervision.

***>>>
 
FROM Jan. 25, 2002: Going off Paxil? Do it slowly

Paxil is approved in Canada and the United States for adult treatment of a
number of psychiatric illnesses including depression. 

Both Health Canada and the FDA have never approved of the drug for people
18-years-old and younger. But some doctors prescribe the drug anyway. 
In Canada, Paxil or Paroxetene is the eighth most commonly prescribed drug,
according to IMS Health statistics. In 2000, more than three million
prescriptions were filled for Paxil. 

***>>>

FROM May 6, 2002: Paxil caused withdrawal illness: Ontario lawsuit

Paxil has been the subject of several class-action suits in both countries.
Plaintiffs argued that they suffered from dependency and withdrawal
reactions. 

Paxil is listed as an SSRI drug - selective seratonin re-uptake inhibitor -
which means it is not supposed to be addictive. Other SSRI drugs are Prozac
and Zoloft. 

GlaxoSmithKline changed its labelling early last year, making it clear some
patients will suffer serious effects if they're taken off the drug too 
quickly. 

Written by CBC News Online staff 

***>>>

Going off Paxil? Do it slowly 
Last Updated Fri, 25 Jan 2002 15:30:55 

WASHINGTON - Doctors in the United States and Canada have been warned
to take their patients off an anti-depressant drug very gradually because of
concerns of adverse reactions. Paxil was introduced to the North
American market in the early '90s. It was marketed as a drug that was 
not supposed to be addictive. 

The drug is used to treat a variety of disorders from depression to 
anxiety to obsessive compulsive disorder. 

Paxil was the most commonly prescribed anti-depressant in Canada
in 2000, with about 3 million prescriptions filled. 

Now, a labelling changeby the drug's manufacturer, GlaxoSmithKline, 
makes it clear some patients will suffer serious effects if they're 
taken off the drug too quickly. 

Doctors in Canada have been given the same warning. 

Last August, 35 people in the U.S. launched a class action lawsuit against 
the pharmaceutical company alleging the drug was addictive and had a 
tendency to induce physical and physiological dependency. 

Paxil is listed as an SSRI drug - selective seratonin re-uptake inhibitor -
which means it isn't habit-forming. Other SSRI drugs are Prozac and 
Zoloft. 

The suit says patients suffered withdrawal reactions. GlaxoSmithKline 
has refused to comment on the matter. 

In Canada, Frank Streicher runs a Web site called quitpaxil.org. He's 
had thousands of responses from people who, like himself, were 
frightened by symptoms as the drug left their systems. 
Some of the people were suicidal. I was getting dizzy while walking, 
says Streicher about his withdrawal symptoms.
 
The most serious symptom...is what people call brain zaps. It feels like 
an electric jolt running from your head down to your feet, every time 
you step or move your head. It lasted three weeks.? 

Psychiatrist Dr. Max Michelon calls it discontinuation syndrome. He says 
up to 10 per cent of people who stop taking Paxil have some form of it 
and about one per cent have severe symptoms. 

Michelon says the drug company hasn't done enough to warn doctors. 
(The) syndrome is much more prominent than it is mentioned to doctors in
general. 

Written by CBC News Online staff