# UK adds suicide warning to antidepressants



## Guest (Oct 19, 2000)

UK to add suicide warning to antidepressantsBy Richard WoodmanLONDON, Oct 17 (Reuters Health) - The UK Medicines Control Agency (MCA) has called for suicide warnings to be added to patient information leaflets for the class of antidepressants that includes Prozac.The possible association between the drugs, called SSRIs, and suicidal behaviour was the subject of intense discussion in the early 1990s following case reports of suicidal behaviour by patients taking Eli Lilly's Prozac (fluoxetine). However the MCA told doctors in 1992 that there was little evidence to support the suggestion that the drug induced suicidal behaviour.The MCA said that since then the Committee on Safety of Medicines (CSM) had recently reviewed adverse reaction reports and other data, and had again concluded that the available study data did not support the idea that fluoxetine causes suicidal behaviour.Nevertheless, "whilst the reporting rate of suicidal behaviour for all SSRIs has been low in recent years, there continue to be anecdotal case reports of suicidal behaviour associated with fluoxetine.""Prescribers and patients should be aware that it is general clinical experience that the risk of suicide may increase in the early stages of treatment with any antidepressant. Patients thought to be at risk should be carefully monitored," the MCA and CSM said in their latest "Current Problems" newsletter.The MCA is now talking to companies about updating SSRI patient information leaflets to include the words: "Occasionally, thoughts of suicide or self-harm may occur or may increase in the first few weeks of treatment with (this drug), until the antidepressant effects become apparent. Tell your doctor immediately if you have any distressing thoughts or experiences."The agency said it was the responsibility of the doctor, who is familiar with that patient's medical history, to decide on the best course of action.The MCA said that although the recent CSM review focused particularly on the SSRIs, the product information for other antidepressants would be reviewed in light of this advice.The wording of the new warning was criticised as "dangerously misleading" by Dr David Healy, head of psychosocial medicine at the University of Wales College of Medicine, who has studied the link between SSRIs and suicidal behaviour.In a letter to the MCA, he said: "Unless your wording indicates that the treatments may in their own right add a further risk of (suicidal thoughts) to whatever risk is inherent in depressive disorders themselves, your advice will lead to a situation where patients who worsen on treatment will be kept on that treatment by GPs in the belief that it is only in this way that the suicide risk can be ultimately lowered."This is "mistaken advice" that will increase the rate at which patients move from thinking about suicide to suicidal acts, he said.Two small studies--including one by Dr Healy--have found that even healthy volunteers can have suicidal thoughts after taking SSRIs.In response, the MCA said reports of suicidal thoughts in healthy volunteers were difficult to explain" and other data was reassuring. For this reason, the issue would be kept under review.A spokesman for the European Medicines Evaluation Agency said that the whole issue is also being kept under unofficial review by the organization.Dr Alexander Simpson, medical director at Eli Lilly UK, said the company was working closely with the MCA on the updated summary of product characteristics and patient information leaflet. However there was "no credible scientific evidence that establishes a link between Prozac and suicidal behavior". Several studies actually suggested Prozac reduced aggressive and suicidal thoughts and behaviours, he said.


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## babydoc_au (Jan 26, 2000)

I Have a very interesting article here from Pharmabullaetin - A newsletter on Psychotropic Drugs, called Suicide and akathisia with fluoxetine from February, 2000. It is largely a reproduction of an article by Sarah Bosely that appeared in the Good Weekend on Dec 1999. It is way too long to reproduce here, but the thread of it is that EliLilly, the company who developed Prozac, knew as early as 1978 that adverse reactions included akathisia and restlesseness (akathisia is a feeling of intense agitation). Also sixteen people involved in trials of the drug attempted suicide (two successfully) despite the fact that people with a risk of suicide were excluded from the study. As a result, the German licensing authority, the BGA would not licence the drug in 1985, citing "suicidal risk" as one of the reasons. Eventually, the BGA granted a licence providing a warning went on the packet which stated there was a risk of suicide and "For his/her own safety the patient must be sufficiently observed until the anti-depressant effect sets in. Taking an additional sedative may be necesary". I now quote the paper "During the licensing process in the US, EliLilly did not tell the FDA of the German concerns. Indeed, the firm's papers disclose a long and sucessful battle against the idea that Prozac could induce violence or suicide. They suggest that Lilly had an explicit strategy to blame the disease and not the drug, and that some of Lilly's own scientists had reservations about this.""A memo from the the German office of EliLilly to the US headquarter's in November 1990 indicates that Lilly was keen to root out the word suicide altogether form its database of side-effects experienced by patients on the drug."Staff were told to report a suicide attempt as an "overdose", (even though it is not possible to kill yourself by overdosing on Prozac) and that "suicidal ideation" should be recorded as depression.In 1995 a Boston based scientist, Herschel Jink, did a study of suicides in Britain among people prescribed anti-depressants. He found that there was 187 suicides per year per 100,000 depressed patients on Prozac. EliLilly argued that sucide rates for people with depression run at 600 per 100,000, but these figures in fact apply to hospitalised patients with depression. For depressed people in the community, the figure is about 30 per 100,000."So, on those figures 157 people prescribed Prozac by their doctors out of every 100,000 will kill themselves because of it"The article goes on, but I'm out of time, the final comment states " Nearly all information about medicinal drugs is controlled by commercial entities with a vested interest in a drug's commercial success. When this is so, it is an illusion to believe one is practicing rational or evidence based medicine-some of the evidence is not public


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## wanderingstar (Dec 1, 1999)

It's about time this happened, although I strongly believe the wording should be such that it makes clear the drug itself can make you feel suicidal, hyperactive, manic and aggressive, rather than the condition. Prozac made me feel awful, worse than just plain old bad depression.


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## JeanG (Oct 20, 1999)

Hi Guy:I saw something about this a few days ago. This is why they say to always keep in very close contact with your doc when taking anti-depressants.There was one I used to take that my doc would do blood tests now and then to see how much I was actually taking in, and she did have to adjust the dosage once.Thanks for posting this.







JeanG


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