A new warning issued by the Medicines Control Agency, stating that people may feel suicidal in the first few weeks of taking Prozac and similar antidepressants, is dangerously misleading and could lead to more deaths, according to a leading authority on the drugs. David Healy, director of the North Wales Department of Psychological Medicine in Bangor, has told the MCA that among those who are not severely depressed - who are the majority of those now being given antidepressants - it is the drugs, and not the illness, that make people want to kill themselves.
The warning will lead to doctors keeping their patients on the drugs in the assumption that the medication will eventually make them better, when they need to be taken off.
The new warning is the MCA's response to increasing public concern over suicides among people on drugs in the Prozac class. The agency has instructed manufacturers to include it in the drug datasheets for doctors and information leaflets for patients. It states that suicidal thoughts may occur or increase in the early weeks of treatment, and may continue for some time until the drug takes effect.
But Dr Healy, the UK's leading historian of antidepressant medication, believes it is the drugs themselves that are causing some people to feel like killing themselves - not depression. And if, as the patient leaflet warning states, there is an increase in suicidal thoughts, he says, it can only be due to an effect of the drug.
But increasingly the SSRIs (selective serotonin reuptake inhibitors) are being given to adults and children who are not depressed, but merely anxious and who should therefore have no suicidal feelings.
Dr Healy has written to Keith Jones, director of the MCA, pointing to two studies - one of them carried out by his own team - showing that healthy volunteers with no history of depression have become dangerously suicidal after taking one of the SSRI class of drugs for a couple of weeks.
"This will lead to deaths," he told Dr Jones in a letter. "Your advice will lead to a situation where patients who worsen on treatment will be kept on that treatment by their GPs in the belief that it is only in this way that the suicide risk can ultimately be lowered. This is mistaken advice that is going to increase the rate at which patients move from emergent suicidality[beginning to feel suicidal] to suicidal acts."
Earlier this year, Dr Healy published a study of the effects of one of the SSRIs, sertraline, on 20 healthy volunteers. Two of them became suicidal. One told researchers that she had become obsessed with the idea of throwing herself under a car or a train, while the other fantasised about hanging herself from a beam in the bedroom ceiling.
The MCA also has in its possession a much earlier study of the effects of sertraline on healthy volunteers. Dr Jones acknowledged in a letter to Dr Healy that this study similarly shows a "pattern of severe adverse side-effects and drop outs." He goes on to remark that the pattern "seen in this small study was not replicated in any other study involving sertraline".
Yet it has been - in the Healy study published earlier this year in Primary Care Psychiatry and revealed in the Guardian in May. These two studies, says Dr Healy, would be conclusive enough for the manufacturers to get a license from the MCA to market sertraline as a drug to cause agitation - if anybody had a use for such a medicine. Yet the MCA will not accept that this, and other SSRIs, can cause people to feel suicidal as a side-effect.
The MCA's decision to require a new warning with the SSRIs was taken after a review of the data by the Committee on the Safety of Medicines.
The MCA said in a statement that the CSM had considered both the healthy volunteer studies as part of the overall risk assessment.
"The CSM concluded that reports of suicidal thoughts in healthy volunteers were difficult to explain, however, other data were reassuring. For this reason, the issue will be kept under review and further advice will be sought as necessary."
