IT was hell going on it and even more
difficult coming off it. After three years of taking Aropax,
a commonly prescribed anti-depressant/anti-anxiety medication,
I was feeling great. I was optimistic about the future and
wanted to see what life after Aropax might look like. I anticipated
withdrawl symptoms, remembering vividly the debilitating side-effects
that knocked me about when I first started taking the medication.
My GP advised reducing the dosage over
a period of time. I went from 20mg to 10mg and then after
a month reduced to 5mg before stopping altogether. A week
later I began to experience a range of withdrawal symptoms.
The first was dizziness, followed by regular electrical shock
sensations or “zaps” in my head. These radiated
down my arms. A few days into this experience I made the mistake
of talking at a luncheon of 100 people. Aropax had removed
the anxiety “peaks” that made public speaking
so difficult for me. I hardly touched the meal and had a small
glass of wine, hoping that it would help to relax me. It didn’t.
I got off to a reasonable start, but soon began fumbling over
my words, unable to collect my thoughts. I became painfully
self-conscious. Fear and self-doubt kicked in. I wished I
had fainted. I had flirted with a public speaking disaster
and lived to tell the tale. It wasn’t as bad as I had
imagined but then again I didn’t get much positive feedback.
I am one of thousands of Australians managing
depression and anxiety. About 800,000 Australians suffered
depression in 2003. In 1997, there were about 50,000 South
Australians experiencing depression and 110,000 experiencing
anxiety disorders. Remarkably, around 15 out of every 100
South Australians experience depression and anxiety disorders.
This might be the tip of an iceberg. While there are alternative
treatment options available, medications are commonly prescribed.
One of the main ones is Aropax, manufactured by the US pharmaceutical
giant GlaxoSmithKline (GSK). Around one million prescriptions
were written for Aropax in Australia in 2002. Anxiety and
depression treatment is a major industry.
Aropax belongs to a class of anti-depressant
drugs called Selective Serotonin Reuptake Inhibitors (SSRIs).
It is thought that Aropax acts on chemicals in the brain called
amines which play a key role in the regulation of mood. The
active ingredient in Aropax is paroxetine hydrochloride. It
is now widely prescribed to treat conditions such as irrational
fears, obessional behaviour, panic attacks and excessive anxiety.
While there appears to be a broad consensus that Aropax is
beneficial for many sufferers, the occurrence of debilitating
side-effects and serious withdrawl symptoms has motivated
some governments to review its use.
GSK admits that taking Aropax can have
serious side-effects. Some of the more common “mild”
ones include feeling sick, dry mouth, constipation, decreased
appetite, diarrhoea, drowsiness, dizziness, difficulty getting
to sleep, impaired sexual function, feeling sweaty or shaky,
bruising and weight gain. More serious side-effects include
muscle spasms or twitches.
While counselling, exercise and a healthy
lifestyle all play a vital role in helping to manage and reduce
the debilitating effects of depression and anxiety, medication
can play a vitally important role. I only contemplated using
anti-depressant/anti-anxiety medication because I was searching
for something that might reduce the relatively high levels
of anxiety that I carried around with me. My GP prescribed
Aropax to me three years ago. He warned that I would probably
feel worse before I felt better but urged me to persist with
it. He was right. Perversely, the drug made me feel worse
than I ever had. This lasted about a week before I began to
feel some benefits. For a few days my anxiety levels spiralled
out of control and I felt nauseous and dizzy. A large bruise
spontaneously appeared on my face. I was told by one GP that
it was unrelated to taking Aropax, but I knew that the manufacturer
had identified bruising as a possible side-effect. It was
impossible to work so I stayed at home, trying to sleep as
much as I could. It took a week or so for the worst of the
side-effects to dissipate. The dry mouth persisted for months
before disappearing and the impaired sexual function persisted
for much longer. While the manufacturer fails to define what
impaired sexual function means, in practice it involves a
loss of interest in sexual activity and difficulty achieving
orgasm. This is hardly a minor side effect. It is possible,
however, to have a healthy sex life while on the drug.
One of the most frustrating side-effects
of Aropax is weight gain. I put on about 10kg and found it
difficult to lose weight despite a healthy diet and regular
exercise.
One of Aropax’s great strengths
is also one of its weaknesses. It helps to significantly reduce
the debilitating effects of depression and anxiety but it
can do so in a way that makes it difficult to experience the
full range of human emotions. It can make it difficult to
cry and to feel joy. For many sufferers this might be a relatively
small price to pay to be rid of the debilitating effects of
depression and anxiety.
Obscured by the hype surrounding the emergence
of “wonder drugs” such as Aropax are allegations
that the side-effects of going on and off Aropax are not being
taken seriously enough by general practitioners. These can
be so distressing that people stop taking the drug before
it has any chance to be beneficial.
What appears to be missing at the point of prescription is
a protocol for managing the use of the drug. Manufacturers
provide little guidance to the medical profession; GSK appears
to have downplayed the difficulties of withdrawing from Aropax.
It simply says “Do not stop taking Aropax even if you
begin to feel better. Your doctor will tell you when and how
Aropax should be discontinued”. It fails to provide
sound, researched evidence on withdrawal, leaving GPs and
specialists to deal with the problem.
It has been alleged that GSK has failed
to be transparent about the risks with Aropax and its adverse
withdrawal effects. Recently GSK was forced to acknowledge
its drug can have effects on teenagers, including extreme
hostility, deeper depression and suicidal tendencies. As a
consequence, the prescription of Aropax to teenagers in Britain
and New Zealand was banned. It is still prescribed in Australia.
The European Agency for the Evaluation
of Medicinal Products established an inquiry into Aropax (paroxetine)
in June 2003. It recommended major changes to product information
distributed throughout the EU. In particular, it recommended
that paroxetine not be used for children and adolescents as
there were indications that the drug might contribute to suicidal
behaviour. The inquiry insisted that prescribers closely monitor
patients at high risk. It also recommended that “...
prescribers and patients should be warned regarding the occurrence
of withdrawal reactions upon stopping treatment”. The
review acknowledged that while “... withdrawal symptoms
tend to be mild to moderate ... they may be severe and/or
prolonged”.
Australia has been slow to act to concerns
raised about the use of Aropax. GlaxoSmithKline should be
compelled to disclose all they know about side-effects and
withdrawal symptoms to an independent review committee established
by the Federal Government. Australian studies also should
be undertaken to make us better informed on the use of paroxetine.
In the meantime, GPs and specialists should work together
to develop a common framework to guide Aropax use –
and they might think about consulting with Aropax users as
they do so.
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