Seroxat: more harm than good?
Seroxat is one of the most popular antidepressants on the market, but this particular medicine is proving to harm some students instead of curing them of their depression.
Despite its popularity, the drug has been reported to have alarming side effects for some users.
In trials it was found that 3.4 per cent of teenagers on the drug experienced mood changes, tried to harm themselves or thought about committing suicide, compared with 1.2 per cent on placebo pills.
Drug company, GlaxoSmithKline (GSK) has known since 1998 that there was a higher risk of suicidal behaviour among under-18s using Seroxat and that the controversial drug was ineffective in dealing with depression in teenagers.
GSK failed to inform its regulator of the findings and told its employees to “effectively manage the dissemination of these data in order to minimise any potential negative effect”.
A later letter from GSK in 2006 explicitly warned doctors in the US that clinical trials “showed a higher frequency of suicidal behaviour in young adults treated with paroxetine [the active ingredient in Seroxat] compared with placebo”.
As a result, suicide is now listed as one of the possible side effects in the safety information enclosed with the medication, as with all of the Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants.
Originally there had been no side effect warnings on the packet about an increase in self-harm, and doctors had not been warned not to prescribe Seroxat to those under 18.
The reason for the difference in risk between adults and teenagers remains unclear. One possible explanation is that young people are more sensitive to missed or delayed doses of Seroxat.
The drug works by inhibiting the production of serotonin in the brain, a chemical that is involved in mood regulation. Seroxat is the most potent type of SSRI and has racked up huge sales for GSK for the treatment of major depression, obsessive-compulsive disorder and anxiety.
Seroxat, also sold under the name Paxil, is the most prescribed drug in the US.
A BBC Panorama programme documented how 16-year-old Sharise Gatchell had taken her own life after being prescribed Seroxat.
In a response to the programme GSK maintained that suicide was a “well-recognised, tragic outcome” of depression, implying that the anti-depressants themselves were not at fault.
Aside from the risk of self-harm, the drug has been extremely difficult for some users to come off. In 2002 a group of over 4,000 Seroxat users launched a lawsuit against GSK for failing to inform them of the drug’s withdrawal risks.
This is not the only lawsuit against GSK – in the US the company is being sued over claims that Seroxat has caused birth defects.
Withdrawal symptoms for the drug can be strong and can include an increase in self-harm. In fact, in 2003 GSK raised the withdrawal risk of Seroxat from 0.2 per cent to 25 per cent overnight.
The risk of withdrawal difficulties went from one in 500 to one in four.
Janice Simmons is head of the Seroxat Users’ Group, an organisation which campaigns on behalf of those who have suffered due to using Seroxat. Simmons’ husband has been on Seroxat for over a decade.
According to Simmons, her husband has been unable to stop using the drug during this long period because of the severity of the withdrawal symptoms that he has experienced when trying to come off it.
Even advocates of the drug have reported its harmful side effects. Dr Peter Swinyard, national chairman of the Family Doctor Association, describes Seroxat as “safe” and says that he has reported no problems with any of his patients.
However, Swinyard has himself been prescribed Seroxat and was compelled to stop taking the drug because it made him feel, in his own words, “terrible”.
Dr Peter Haddad, consultant psychiatrist for Salford's Mental Health Service NHS Trust, told the British Medical Journal that "withdrawal side effects from antidepressants are far more common than many people realise, and there's evidence that paroxetine [active ingredient in Seroxat] has one of the highest rates”.
And what of those who should be protecting the public from potentially dangerous medication?
The Medical Health products Regulatory Agency (MHRA) has been criticised for its handling of the problems associated with Seroxat.
In 2003, after reports of undisclosed side effects, the MHRA came under scrutiny.
The main source of contention was that the data which showed a link between Seroxat and suicidal thoughts in teenagers had been in the hands of the MHRA for some time, yet for some reason this information hadn’t been passed on to doctors or the public.
GSK were accused of burying controversial information amid reams of trial data.
There appears to have been a conflict of interests at the MHRA.
Following patient complaints, in 2003 the MHRA set up an Expert Working Group (EWG) to investigate Seroxat.
In that inquiry, two of its four members were forced to resign after they were found to be shareholders in GSK, and the EWG was prematurely dissolved.
The question of whether people with vested interests in pharmaceutical companies should serve on these committees was put to a member of the MHRA, who replied: “The short answer is that there are virtually no experts who don’t have some interests with drug companies.
“We work in pharmacy. There are studentships, postgraduates who may get from £5,000 to £100,000 from companies – not necessarily to work on a product specifically. Many members of the MHRA do consultancies for companies – that’s where they make their money. But they are obliged to declare their interests.”
When drugs are submitted for approval, manufacturers are allowed to only select the trials that showed measurable results and discount the rest. Two positive trials are enough for a drug to be approved.
Irving Kirsch, a professor of Psychiatry at the University of Hull, thinks the system is deeply flawed.
“It would be OK if one only conducted two trials. If one conducts a large number of trials, saying two are statistically significant is no longer meaningful,” he said.