Seroxat, the British-made antidepressant which outsells Prozac, causes more people distressing withdrawal problems when they try to stop taking it than any other drug in the UK.The committee on the safety of medicines, which receives reports of drug side-effects from doctors and pharmacists, has received an avalanche of complaints about Seroxat, one of the class of drugs known as SSRIs (selective serotonin reuptake inhibitors). The SSRIs, including Prozac, have always been marketed as safe medicines which are supposed not to cause the dependence problems that emerged with older drugs such as Valium and Ativan.Seroxat – known generically as paroxetine – leads the top 20 table of drugs causing withdrawal problems, with 1,281 complaints from doctors under the “yellow card” scheme set up for the reporting of medicines’ side-effects. More reports have been filed about Seroxat than about the rest of the top 20 put together. In the top six, five of the drugs said to be causing withdrawal problems are SSRIs – second after Seroxat comes Efexor (venlafaxine), with 272 complaints.The figures were obtained from the medicines control agency, the regulatory authority which takes advice from the CSM, by the campaigning group Social Audit.
Charles Medawar of Social Audit has complained to the MCA and the CSM about the patient information leaflet supplied with Seroxat which he says is misleading and wrong. “These tablets are not addictive,” the leaflet states, adding that the withdrawal problems some patients experience “are not common and are not a sign of addiction”.
However, many people in the UK have consulted lawyers over the unexpected problems the drug caused them when they wanted to stop taking it. Mr Medawar drew to the MCA’s attention the hundreds of postings on the group’s website from people who have suffered and continue to suffer distressing symptoms as a result of trying to give up Seroxat. They complain of sensations that feel like electric shocks in the head, dizziness, mood swings, upset stomachs and unpleasantly vivid dreams, all of which are only alleviated by going back on the drug.
“I’ve been on Seroxat for about 10 years,” wrote one woman in January, “and have tried to come off them on many occasions, only to find myself back to my original dose of 30mg because of the horrible withdrawals … I was assured when talked into taking anti-depressants in the first place (that they) were one of the mildest and non addictive so-called ‘wonder-drugs’ in modern psychiatry!”
The SSRIs are commonly prescribed by GPs – not psychiatrists – to people who consult them with mild depression and sometimes other conditions, such as ME, anxiety and phobias.
Mr Medawar points out that the GPs are not warned of the withdrawal problems the drug can cause and often think the symptoms their patient suffers when stopping the medicine are just a return of their original ailment.
In a letter to Keith Jones, director of the MCA, he said that “the categorical and repeated assurance that Seroxat/paroxetine is not addictive seems to me completely unwarranted and highly likely to mislead and confuse patients and doctors alike. My view is that the MCA and CSM have failed the public and continue to fail the public – a gross dereliction of duty and responsibility to users, I would say”.
In its response, the MCA acknowledges that the UK yellow card data shows a similar pattern to that of the World Health Organisation adverse drug reaction monitoring centre in Uppsala, Sweden, which put paroxetine at the top of the list and venlafaxine second in a table of withdrawal problems.
June Raine, who has responsibility at the MCA for the safety of licensed medicines, gave a clear indication that the agency may break with tradition and take into account complaints that come from patients as well as those from doctors and pharmacists.