Users call for antidepressant ban to be extended to new adult patients

The government has advised that the antidepressant drug Seroxat
should no longer be used to treat depression in children and
adolescents. As welcome as this news may be, an even bigger
question remains unanswered. Is the drug appropriate for
adults?

Seroxat, prescribed for a range of conditions including depression,
anxiety, and obsessive compulsive disorder, has generated many a
headline over the past year. Last week a woman escaped a prison
sentence after claiming that she only attacked someone in a
nightclub because of mood swings caused by the drug.

And she is by no means the first to attribute behavioural changes
to Seroxat. The indications are that when people start taking
Seroxat (the brand name for paroxetine) many suffer from
side-effects, such as weight gain, increased anxiety or depression,
and even suicidal thoughts and behaviour. Others experience such
unpleasant withdrawal symptoms that they are unable to stop taking
the drug, which belongs to a group of antidepressants known as
selective serotonin reuptake inhibitors and works by increasing the
level of the chemical serotonin in the brain.

Earlier this month, the Medicines and Healthcare products
Regulatory Agency (MHRA) declared that Seroxat should no longer be
used to treat depressive illness in children and teenagers as a
result of new data examined by the Committee on Safety of Medicines
(CSM), the government’s independent advisory committee.

Three clinical trials compared the effect of paroxetine with a
placebo and found that the drug worked no better than the sugar
pills in treating depression in under-18s. Even more worryingly,
the trials indicated that taking Seroxat increased the risk of
suicidal thoughts and behaviour by between 1.5 and 3.2 times.

Understandably, the new advice from the CSM is likely to cause
concern. Estimates suggest that around 4 million prescriptions for
Seroxat are issued every year in the UK, of which less than 1 per
cent is for under-18s. Seroxat has never been licensed for use in
children and adolescents, but doctors are able to prescribe a
medicine “off-licence” if it’s considered to be in the best
interests of the patient.

The CSM has stressed that children and adolescents should not
suddenly stop taking Seroxat but should consult their doctor on
what to do. This advice relates to the treatment of depressive
illness – the position on other conditions is yet to be
established.

But surely if the drug is deemed to be inappropriate for children
and adolescents then it may well carry risks for adults too? In May
an expert group of the CSM was set up to look into the safety of
SSRI antidepressant drugs, and this group will look at whether the
new findings have any implications for adults. The CSM currently
states that childhood depression is different from adult depression
and that “a number of antidepressants that have been shown to be
beneficial in adult depression have been shown not to work in
childhood depression”.

It stresses that the advice for adults has not changed and that
patients should not panic and suddenly stop their medication. The
drug is an effective treatment and the “benefits of treatment
outweigh the risks”, it states.

However, by no means everyone shares this view. Sarah Venn,
chairperson of the Seroxat Users’ Group, believes that the drug
should be banned for adults too until research has proved its
safety. The Seroxat Users’ Group was set up to provide support to
patients using Seroxat and now has more than 5,500 members.

According to the group many people have found that Seroxat causes
psychiatric problems which have, in some cases, led to violent
behaviour and even suicide. Venn says that there have been more
than 30 suicides within days of people starting to take
Seroxat.

“More people are coming forward every day saying they never thought
it was the drug,” she says.

In addition, she says that when people try to stop taking the drug
many experience symptoms such as dizziness, electric shocks, muscle
spasms, paranoia and depression. Venn herself has been on Seroxat
for six years. She’s tried to come off it on three occasions, but
each time found herself unable to leave her bed.

“I’ve pretty much given up on ever getting off it,” she says.

The group wants the information for prescribers and on patient
leaflets to be improved, with warnings that taking Seroxat can lead
to suicidal thoughts and behaviour in the first few weeks, that
some patients are likely to find it difficult to stop taking it,
plus guidance on the need to withdraw slowly.

Had she known all this, Venn says she would have acted
differently.

“I’d never have taken it but that information wasn’t known. I don’t
blame my doctor at all. He doesn’t prescribe it any more as there
have been enough problems in his practice,” she says.

In May the Seroxat Users’ Group demonstrated with mental health
charity Mind outside the London offices of the MHRA to put pressure
on the agency to withdraw Seroxat for new prescriptions until the
outcome of an independent review involving the experiences of
people who have taken the drug.

Mind has been one of the leading campaigners on the issue. The
charity, with the BBC’s Panorama, carried out research with 239
people who had taken Seroxat. The research found that 97 per cent
had suffered an unwanted or uncomfortable reaction and half had
experienced self-harm or suicidal urges. More than eight out of 10
had experienced withdrawal problems and two-thirds of those who had
tried to stop taking the drug felt unable to.

But not everyone agrees that Seroxat should also be banned for
adults. David Healy, an expert on antidepressants and consultant
psychiatrist at the University of Wales’ College of Medicine,
believes that rather than being banned, the drug should come with
better warnings. He says that Seroxat is “the right drug” for some
and that he uses it to treat people.

“The key thing is to let people know that during the first weeks of
treatment they may begin to feel worse and that it may be caused by
the drugs they are on,” he says.

Such changes could include increased anxiety, thoughts about
harming themselves or others, and out of character behaviour.

“If people are warned about these things and if anyone who lives
with them knows there is a risk then we can pick this up quickly,”
he says. In addition people need to be told that there is a risk
that some people will become physically dependent and says that
some may find it hard to ever get off it.

One particular problem concerns the depression and anxiety that
some people feel when they start to withdraw. When they consult
their doctor they are told that this is the initial illness that
was being treated and consequently they end up back on medication.
In addition, Healy thinks that some patients are prescribed
medication for mild problems and that GPs would be slower to
prescribe if they were more aware that some people can get hooked.

Seroxat manufacturer GlaxoSmithKline insist that the MHRA’s
decision is solely concerned with the treatment of children and
teenagers and is not related to the use of Seroxat by adults “where
this treatment has proven effective and has helped millions of
people around the world”.

So, for the time being at least, Seroxat will continue to be used
to treat depression in adults. But for the many who question its
safety, their minds will not be put at rest until the outcome of
the independent review later this year.