• John Spoehr

29 September 2004More work is needed on helping patients deal with the side-effects of anti-depressants, argues John Spoehr.

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 withdrawal 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 Australian’s managing depression and anxiety. Around 800,000 Australians suffered depression in 2003. While there are alternative treatment options available for depression and anxiety, medications are commonly prescribed. One of the main medications prescribed for treating depression and anxiety is Aropax, manufactured by the US pharmaceutical giant GlaxoSmithKline. 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, or 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 including 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 safety.

GlaxoSmithKline admits that taking Aropax can have serious side effects. Some of the more common ‘mild’ side effects include feeling sick, dry mouth, constipation, decreased appetite, diarrhoea, drowsiness, dizziness, difficulty getting to sleep, impaired sexual function, feeling sweaty or shaky, bruising, 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 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 initially made me feel worse than I ever had. For a few days my anxiety levels spiraled 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 around 10 kilograms and found it very difficult to loose 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’ like Aropax are allegations that the side effects of going on and off the medication are not being taken seriously enough. Most general practitioners and specialists prescribing Aropax are aware that it can have serious and debilitating side effects. 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. At the moment the manufacturers provide little guidance to the medical profession on the management and reduction of distressing side effects.

Indeed, GlaxoSmithKline appears to have downplayed the difficulties of withdrawing from Aropax. The advice on withdrawal provided by the company is woefully inadequate. 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 soundly researched evidence to users on the side effects of withdrawl, leaving GPs and specialists to deal with the problem on their own. It has been alleged that GlaxoSmithKline has failed to be transparent about the safety and adverse withdrawl effects of Aropax. Recently the company was forced to acknowledge that Aropax can have serious side effects for 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 of suicidal behaviour. It also recommended that ‘prescribers and patients should be warned regarding the occurrence of withdrawl 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. Many GPs and specialists have a solid knowledge and a growing understanding of how to better manage the prescription of Aropax, but they appear to have been let down by the manufacturer which has not been sufficiently open to the medical community and the public about how difficult and distressing paroxetine withdrawl can be. 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 should also be undertaken on the side effects and difficulties associated with withdrawal to better inform the use of paroxetine in Australia. In the meantime GPs and pecialists should work together to develop a common framework to guide Aropax use and withdrawal. They might think about consulting with Aropax users as they do so.

John Spoehr is executive director of the Australian Institute for Social Research, University of Adelaide. This article first appeared in the Adelaide Review