September 16 2002
Note: Paroxetine Hydrochloride is also known as Seroxat or Paxil
800 hooked on drug seek legal action
Patients say warning on side effects inadequate
Sarah Boseley, health editor
More than 800 men and women who have found themselves hooked on the antidepressant Seroxat are seeking legal action against the British manufacturers, increasing the pressure for tougher warnings about the drug’s side effects.
The potential litigants want to force Glaxo SmithKline to change the information it puts out to doctors and patients. They want the company to warn that significant numbers of people can become dependent on the drug -an SSRI (selective serotonin reuptake inhibitor) like Prozac – which GPs often prescribe for relatively minor depression.
As the numbers of those seeking action in the UK continue to rise, a row is under way in the United States where a federal court judge has ordered Glaxo to pull television advertisements which state the drug is “non-habit forming”.
Mark Harvey, of the solicitors Hugh James in Cardiff, who has most of the UK cases, said his clients were most anxious to get an adequate warning on the drug and research into the dependency problems and aggression they say they have experienced. Compensation for their distress, which in some cases is said to have lasted years and wrecked lives, was a lesser priority.
Mr Harvey said the cases were still coming in at the rate of around a dozen a day. The scale of the problem was so great that he believed the medicines control agency (MCA), which regulates pharmaceutical drugs, should take action.
“I have written to the MCA who have continued to say there isn’t a problem here because we accept what the companies tell us,” he said.
“The system for reporting adverse drug reactions has never been satisfactory. I have got 800. I suggested they might listen to the stories my clients tell and accept those as reports.”
Only doctors, and, more recently, pharmacists and some nurses, can send reports of problems with drugs to the MCA through what is known as the yellow card scheme – not the patient who is experiencing the side effects.
Only a few doctors ever send in reports, however, and most experts believe the scale of drug-induced illness is under-estimated.
Seroxat has topped the league for yellow card reports of withdrawal problems by some distance, with 1,281 reports to date.
“They can’t continue to say there isn’t a problem when I have 800 people,” said Mr Harvey. “The World Health Organisation has said there is a problem. This is like a living clinical trial.”
The MCA has recently said that it may be willing to consider some way of accepting reports of side effects from patients themselves.
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