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Drug Approvals

(BANM, US Adopted Name, rINNM)

International Nonproprietary Names (INNs) in main languages (French, Latin, Spanish):

Note. The following terms have been used as ‘street names’ or slang names for various forms of fluoxetine: Distas; Green and whites; Greens; Limes; Pros; Zacs.

Pharmacopoeias. In Europe and US.

European Pharmacopoeia, 6th ed. (Fluoxetine Hydrochlonde). A white or almost white crystalline powder. Sparingly soluble in water and in dichloromethane freely soluble in methyl alcohol. A 1% solution in water has apH of 4.5 to 6.5.

The United States Pharmacopeia 31, 2008 (Fluoxetine Hydrochlonde). A white to off-white crystalline powder. Sparingly soluble in water and in dichloromethane freely soluble in alcohol and in methyl alcohol practically insoluble in ether. Store in airtight containers.

Adverse Effects

SSRIs such as fluoxetine are less sedating than tricyclic antidepres sants and have fewer antimuscarinic and cardiotoxic effects. Adverse effects reported with SSRIs include dry mouth and gastrointestinal disturbances such as nausea, vomiting, dyspepsia, constipation, and diarrhoea. Anorexia and weight loss may also occur. Neurological adverse effects have included either anxiety, restlessness, nervousness, and insomnia, or drowsiness and fatigue headache, tremor, dizziness, seizures, hallucinations, confusion, agitation, extrapyramidal effects, depersonalisation, mania, panic attacks, sexual dysfunction, and symptoms suggestive of a serotonin syndrome have also occurred. The concern that SSRIs may be associated with increased suicidal ideation is discussed under Effects on Mental State, below.

Excessive sweating, pruritus, skin rashes, alopecia, photo sensitivity, and urticaria have also been reported. Angioedema and anaphylactoid reactions have occurred. In some patients who have developed rashes while taking fluoxetine, systemic hyper sensitivity reactions involving the lungs, kidneys, or liver, and possibly related to vasculitis, have developed it has therefore been advised that fluoxetine therapy should be stopped in any patient who develops a skin rash. Hyponatraemia, possibly due to inappropriate secretion of antidiuretic hormone, has been associated with the use of antidepressants, particularly in the elderly. Hyperprolactinaemia and galactorrhoea have occurred, as have changes in blood sugar, in patients receiving SSRIs.

Arthralgia and myalgia have been reported and there have also been cases of orthostatic hypotension, yawning, urinary retention, and abnormal vision including blurred vision and mydriasis. Abnormal liver function tests have been reported rarely. SSRIs have occasionally been associated with bleeding disorders such as ecchymosis and purpura and other effects on the blood. In overdosage nausea, vomiting, and excitation of the CNS are considered to be prominent features death has been reported.

Incidence of adverse effects. In June 1992 the UK CSM had received 1236 reports of adverse effects with fluvoxamine (from about 280 000 prescriptions) compared with 2422 for fluoxetine (from about 480 000 prescriptions). The overall patterns of adverse effects were similar but dermatological reactions were more likely with fluoxetine and gastrointestinal reactions with fluvoxamine. Reports of attempted suicide increased after adverse publicity about SSRIs in 1990, and the number of reports per million prescriptions were similar for the 2 drugs (25 for fluoxetine and 20 for fluvoxamine) at that time such figures were not considered disconcerting given that features of depression, including attempted suicide, can worsen after the introduction of any antidepressant (see also Effects on Mental State, below). A later review by the CSM of the 5 SSRIs available in the UK (citalopram, fluoxetine, fluvoxamine, paroxetine, and sertra-line) found that the SSRIs were broadly similar with respect to their safety profile. A list of adverse reactions common to all SSRIs was provided.

A review of 1861 adverse reactions to citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline reported to the Swedish Adverse Drug Reactions Advisory Committee found that the most commonly reported reactions were neurological (22.4% of all reports), psychiatric (19.5%), and gastrointestinal (18.0%). Compared with other SSRIs, gastrointestinal symptoms were more common with fluvoxamine, psychiatric symptoms with sertraline, and dermatological symptoms with fluoxetine. A more recent meta-analysis has compared the adverse effect profile of fluoxetine with other antidepressants including the tricyclics and other SSRIs. The overall risk of any adverse effect with fluoxetine was less than that for the tricyclic antidepressants however, there was no difference in risk when fluoxetine was compared with other SSRIs. When considering individual adverse reactions, fluoxetine was more likely to cause activating effects such as insomnia, agitation, tremor, and anxiety, and gastrointestinal disturbances such as nausea, vomiting, diarrhoea, weight loss, and anorexia than other antidepressants. In contrast, the tricyclics were associated with a greater risk of sedation, an-timuscarinic effects (such as dry mouth, dizziness, and blurred vision), constipation, and weight gain, than fluoxetine.

Effects on the blood. Abnormalities in platelet aggregation were associated with fluoxetine given to a severely underweight patient. Platelet activity returned to normal when fluoxetine was stopped. Fluoxetine was also suspected of being the cause of bruising in a patient whose blood clotting parameters were within normal limits. Purpura and bruising have been reported to be the commonest adverse blood effects associated with fluoxetine, paroxetine, or sertraline although cases of thrombocytopenia have been recorded for all three antidepressants. The suggested mechanism was inhibition of uptake of serotonin into platelets, thereby disrupting platelet aggregation caution was recommended when treating patients with a history of bleeding disorders with SSRIs. However, a subsequent cohort study based on prescription-event monitoring provided only weak evidence of a link between the use of SSRIs and the development of bleeding disorders. A similar study found no evidence of a major increased risk of intracranial haemorrhage with the use of SSRIs, although smaller increases in risk could not be ruled out.

For mention of a possibly increased risk of gastrointestinal bleeding, see Effects on the Gastrointestinal Tract, below.

Effects on the cardiovascular system. SSRIs are not associated with the same degree of cardiotoxicity as the tricyclic antidepressants, although orthostatic hypotension has been reported in some patients. A decrease in heart rate with ECG changes has been noted with fluvoxamine. However, a study on long-term fluvoxamine treatment in 311 patients followed for 1 year revealed no significant effect on ECG findings compared with patients given placebo.

Concern over the use of sertraline in patients with coronary heart disease was raised after a report of a 53-year-old man with a history of coronary heart disease who experienced attacks of sudden precordial chest pain on starting treatment with sertraline. The pain responded to glyceryl trinitrate. The manufacturers pointed out that there had been no ECG changes confirming an ischaemic origin of the disorder in this patient and that in studies sertraline had had no demonstrable clinical effects on intraven-tricular conduction or ECG intervals. Furthermore, no significant changes in cardiovascular indices had been recorded in patients who had taken overdoses of up to 6 g of sertraline. It was suggested that this might have been an effect on the gastrointestinal tract possibly at the oesophageal level.

Effects on the cerebrovascular system. There have been rare reports of cerebral ischaemic events associated with the use of SSRIs. In one case a 57-year-old man receiving long-term treatment for atrial fibrillation and hypercholesterolaemia presented with a facial droop and slurred speech 3 days after starting paroxetine 20 mg twice daily. Symptoms resolved after anticoagulant therapy and stopping paroxetine but recurred when paroxetine was reintroduced at a dose of 10 mg twice daily. Paroxetine was stopped and no further episodes had occurred within 4 months at follow-up.

For a report that there is no major increased risk of intracranial haemorrhage associated with the SSRIs, see Effects on the Blood, above.

Effects on the endocrine system. The syndrome of inappropriate antidiuretic hormone secretion (SIADH) with hyponatraemia has been reported in patients receiving antidepressants. The UK CSM, commenting on reports it had received of hyponatraemia associated with antidepressants (fluoxetine, paroxetine, lofe-pramine, clomipramine, and imipramine), considered that it was likely to occur with any antidepressant, and usually involved elderly patients. However, the results of a later study have suggested that cases are more likely to occur with serotonergic antidepressants such as the SSRIs, clomipramine, and venlafaxine. Case reports of hyponatraemia in 16 patients treated with SSRIs have been summarised. A further review of reports on 15 patients with hyponatraemia with SIADH induced by fluoxetine (12 cases), fluvoxamine (2 cases), and paroxetine (1 case) showed that the risk was greatest during the early treatment phase. This is borne out by single-case reports of hyponatraemia with SIADH in elderly patients receiving either citalopram, paroxetine, or sertraline. A retrospective study of hyponatraemia associated with either fluoxetine or paroxetine use also showed the early onset of the condition and identified low body-weight as being another risk factor for developing hyponatraemia. Not unexpectedly, replacing one SSRI with another has resulted in a recurrence of hyponatraemia however, in one report, the symptoms of hyponatraemia did not recur until about 16 months after switching SSRIs.

SSRI-associated hyperprolactinaemia has been reported. Lactation and raised prolactin levels occurred in a teenager 3 days after fluoxetine was added to her existing therapy which included pimozide. Stopping fluoxetine had no effect on lactation, which only ceased after withdrawing pimozide. In another report, hyperprolactinaemia and galactorrhoea in an elderly woman receiving fluoxetine resolved on stopping the drug. Gynaecomastia, unrelated to prolactin concentrations, was associated with the start of fluoxetine therapy in a 49-year-old man. Symptoms subsided 10 months after withdrawing fluoxetine. Although S SRIs may be favoured for the management of depression in patients with diabetes, there is some evidence that sertraline and fluoxetine can induce hypoglycaemia. Licensed product information for other SSRIs also warns of similar risks with these products.

Effects on the eyes. Symptoms of glaucoma that developed in a patient receiving fluoxetine subsided within 2 days of drug withdrawal. Similar symptoms have been reported with citalopram, fluvoxamine, paroxetine, and sertraline. In some cases, the SSRI may have aggravated pre-existing glaucoma. Intra-ocular pressure after doses of fluoxetine was recorded in 20 patients in a placebo-controlled crossover double-blind study. Significant increases were found in all patients 2 hours after receiving fluoxetine by mouth some patients still had raised intraocular pressure after 8 hours. A review of case reports documenting SSRI-associated changes in intra-ocular pressure concluded that such changes were difficult to predict however, it was recommended that those with risk factors for glaucoma, such as elderly patients with a family history, should be considered for ophthalmic consultations before starting an SSRI and regularly throughout treatment.

Anisocoria (uneven pupillary dilatation) has been reported in a patient taking paroxetine and in another taking sertraline. It was noted that the UK CSM had received 21 reports of mydriasis associated with paroxetine but it appeared that noticeably asymmetrical mydriasis as seen in these 2 patients had not previously been reported.

Effects on the gastrointestinal tract. A case-control study suggested that treatment with SSRIs produced a moderately increased risk of upper gastrointestinal bleeding (adjusted relative risk 3.0). The risk was greatly increased if SSRIs were given with NSAIDs (relative risk 15.6). Treatment with SSRIs did not appear to increase the risk of ulcer perforation. The absolute risk of bleeding was estimated at one case per 8000 prescriptions, a risk similar to that of low-dose ibuprofen. A more recent cohort study found a similar increase in risk. However, others have questioned whether such an association exists. A retrospective cohort study in elderly patients found that there was an increasing risk of upper gastrointestinal bleeding as the extent of inhibition of serotonin reuptake by the antidepressant used increased. The effect was considered to be clinically important for patients with a high risk of such bleeding, namely the very elderly and those with a history of previous upper gastrointestinal bleeding.

Some consider that gastroprotection is unlikely to be justified in those given SSRIs alone and furthermore there are no studies to suggest that gastroprotective drugs reduce the risk of SSRI-associated haemorrhage. However, it has been recommended that such protection should be considered when SSRIs and NSAIDs are used together because of the increased risk.

Effects on the hair. A report on 2 patients who had hair loss associated with the use of fluoxetine noted 4 other published cases and stated that, up to the end of 1991, the US manufacturers had received 498 reports of fluoxetine-associated alopecia.

Effects on the liver. Acute hepatitis occurred in 2 patients after several months of fluoxetine treatment it was noted that 5 other cases of acute hepatitis with fluoxetine had been reported. Abnormal liver function tests were seen in a patient after a suicide attempt with sertraline and cefalexin. The patient was then started on venlafaxine but, again abnormal liver function tests were noted. When these abnormal values had decreased, sertraline was restarted at therapeutic doses, with a subsequent increase in liver function tests. Values returned to normal once all medications were stopped. Autoimmune hepatitis has been reported after therapeutic doses of sertraline rechallenge in this case was also positive.

Hepatotoxicity has also been rarely associated with citalopram and with paroxetine use.

Effects on mental state. As early as 1990 there was concern that the SSRIs increased the risk of suicidal ideation after the publication of a case series of such events with fluoxetine. Meta-analyses performed around that time (criticism of statistical power notwithstanding) did not confirm an increased risk and this was supported by the results of prescription-event monitoring. Nevertheless, reports of suicidal ideation as well as suicide and self-harm have continued to be published for the SSRIs and the issue remains controversial. A subsequent meta-analysis of 702 randomised controlled studies found an increased risk for attempted suicide in those taking SSRIs when compared with placebo but not when compared with tricyclic anti depressants.

Risk analysis of suicidal behaviour with any antidepressant is confounded by the rarity of suicide even in patients with depression, and by the possibility that such behaviour is a manifestation of the underlying depression. Furthermore, the more favourable safety profile of the SSRIs, particularly in overdosage (see Depression), when compared to the older MAOIs and tricyclic anti depressants may have resulted in the SSRIs being prescribed to those patients at greater risk of suicidal behaviour. In 2003, the UK CSM established an Expert Working Group to address increasing public concerns regarding the safety of the SSRIs. The serotonergic antidepressants venlafaxine and mirtazapine were also included and the conclusions given below also apply to these drugs. In its final report issued in December 2004, the Working Group concluded that the risk of suicide may increase in the early stages of treatment for depression in adults and consequently careful and frequent monitoring is important, particularly if a patient has worsening of symptoms or new symptoms after starting therapy. However, the Working Group noted that increases in the prescribing of SSRIs have not been associated with an increase in suicide rates, although they acknowledged that the interpretation of these findings was difficult. They could not rule out that there might be a modest increase in the risk of suicidal ideation and self-harm with the SSRIs when compared with placebo. However, there was insufficient evidence from clinical trials to determine any differences between the SSRIs as a group, or between the SSRIs and other antidepressants regarding the risk of suicidal behaviour evidence from the General Practice Research database has suggested that there is no increased risk of such behaviour with the SSRIs when compared with the tricyclic antidepressants. The Working Group also concluded that the evidence for a relationship between suicidal behaviour and a change in dose was not robust however, patients should be monitored for any new symptoms or worsening of disease around the time of any dose change.

The Expert Working Group of the CSM has also commented on the use of SSRIs in young adults. They concluded that although there was no clear evidence of an increased risk of self-harm or suicidal thoughts in young adults of 18 years or over, such patients have a higher background risk of suicidal behaviour than older adults and consequently those treated with SSRIs should be closely monitored. Furthermore, the results of a meta-analysis undertaken by the FDA found that although the overall risk of suicide was not increased in adult patients receiving antidepressants, there was a non-significant trend toward increased risk with younger age. The FDA considered the trend sufficiently convincing to warn that, like children and adolescents, young adults aged between 18 and 24 years treated with antidepressants of any type may be at increased risk of suicidal thinking and behaviour.

In 2003 the CSM recommended (on the basis of their Expert Working Group’s finding) that paroxetine should not be used to treat depressive illness in children under 18 years old. Data from studies received by CSM in May 2003 failed to show that paroxetine was effective in depressive illness in this age group and indicated that the risk of harmful outcome, including self-harm and potentially suicidal behaviour, was 1.5 to 3.2 times greater in those who received paroxetine when compared with placebo. Following a further review, the CSM extended their recommendation to include the SSRIs citalopram, escitalopram, and sertraline subsequent analysis had also associated these antidepressants with an unfavourable risk to benefit ratio in the treatment of depression in children under 18. The CSM also included fluvoxamine in their recommendation as its risk to benefit ratio was unassessable. Fluoxetine was not included and the CSM acknowledged that clinical trials had shown a favourable risk to benefit ratio for fluoxetine in the treatment of depression in young patients. The European Medicines Agency (EMEA) has also recommended that serotonergic antidepressants, including the SSRIs, should not be used in children and adolescents except within their approved indications, but considered that studies with fluoxetine in children and adolescents have shown a positive effect that outweighs any potential risks, and recommended that it should be licensed for use where needed, as an adjunct to psychological therapies in children from 8 years of age.

The FDA have not issued advice contra-indicating the use of these antidepressants in those under 18 years old in the USA, although they have stressed that all patients, including adolescents and children, should be closely monitored for worsening depression or suicidal behaviour, especially at the beginning of treatment. They also comment that, apart from fluoxetine, the SSRIs are not licensed in the USA for the treatment of depression in young patients.

The use of SSRIs has been associated with the development of akathisia, restlessness, and psychomotor agitation such as an inability to sit or stand still, particularly in the first few weeks of treatment. In some patients these symptoms have precipitated suicidal behaviour. However, the Expert Working Group of the CSM considered that it was not possible to draw any conclusions on the link between the development of these symptoms and the risk of suicidal behaviour, as such data were not included in the majority of cases.

There have been suggested links between the use of fluoxetine and irritability, hostility, and aggression However, one review noted that an unpublished analysis had indicated that patients taking fluoxetine for a variety of disorders were not more likely to be aggressive than those taking placebo. Prescription-event monitoring has also found no evidence to suggest that fluoxetine increases the frequency of aggression. Initiation of antidepressant therapy with paroxetine or sertraline has been associated with either worsening or a new onset of flashback syndrome in 2 patients with a history of lysergide abuse.

There have been isolated reports of memory loss associated with the use of SSRIs.

For further effects on mental function, see also under Withdrawal and under Mania in Precautions, below.

Effects on sexual function. Sexual dysfunction is often noted in patients with depression and may be due to their antidepressant medication or to the disease itself. Complaints include a decrease in or loss of libido, delayed ejaculation, erectile difficulty, or anorgasmia in men loss of libido, delayed orgasm, or anorgasmia have been reported in women. Early identification is important since drug-induced sexual dysfunction is a common cause of non-compliance in addition, it may adversely affect the quality of life of patients and hamper their recovery. It has been considered that sexual dysfunction occurs in up to 1.9% of patients taking fluoxetine, with impotence or ejaculatory problems occurring in less than 1% of patients. However, these figures, which were based on information supplied by the US manufacturer, have been disputed’ and the incidence of sexual dysfunction may be higher than the manufacturer’s data suggest. Earlier studies and anecdotal reports quoted rates of 7.8 to 75% for sexual dysfunction with fluoxetine but it appears that only small numbers of men were studied. A later review also estimated the incidence of SSRI-induced sexual dysfunction at between 10 and 75%.

The incidence of sexual dysfunction may differ between types of antidepressants. A large, observational study found the rate of sexual dysfunction to be higher with the SSRIs (citalopram, fluoxetine, paroxetine, and sertraline) and the SNRI venlafaxine than with bupropion or nefazodone. However, no significant difference in rate was found among the SSRIs as a group. The study also identified other risk factors for developing sexual dysfunction which included increasing age, the use of high doses, and use with other medications. Gender, race, and length of treatment were not associated with an increased risk. Suggested strategies for managing SSRI-induced sexual dysfunction include reducing the dosage of the SSRI or altering the timing of doses, or changing to another antidepressant. In some cases tolerance may develop, particularly if the dysfunction occurred early in treatment. One small study has indicated that spontaneous improvement may occur even up to 6 months after the start of therapy. Evidence of efficacy for drug treatments is mainly anecdotal. Cyproheptadine seems to have been tried most often, but the SSRI may become less effective (see Antihistamines, under Interactions, below) and patients should be monitored for worsening symptoms of depression. The effects of the SSRIs on sexual function have been studied as a potential form of treatment for men with premature ejaculation (see Sexual Dysfunction in Uses, below).

Effects on the skin. Toxic epidermal necrolysis developed in a 16-year-old girl 8 days after beginning fluvoxamine therapy. Other drugs, which included metoclopramide, clorazepate, and clomipramine were discounted as possible causes. Amitriptyline and fluoxetine have been implicated in the development of atypical cutaneous lymphoid hyperplasia in 8 patients, 7 of whom either had an underlying immunosuppressant systemic disease or were also receiving immunomodulatory drugs. The lesions improved or resolved on stopping the antidepressant, although in some patients other factors may have contributed to the improvement.

Bullous pemphigoid induced by fluoxetine has been reported in a 75-year-old woman. Spontaneous resolution followed within 3 weeks of stopping the drug.

Paroxetine treatment has been associated with the development of cutaneous vasculitis, which involved several fingers, in a 20-year-old woman rechallenge was positive. On both occasions the patient recovered when paroxetine was withdrawn.

A severe bullous reaction with full-thickness skin necrosis has been reported in a 48-year-old woman after 6 months of treatment with sertraline. The lesions required extensive skin grafts and recovery was prolonged, with drug-induced scleroderma developing in the affected area.

Epileptogenic effect. Generalised seizures have been reported in 2 patients with no history of seizures after starting fluoxetine therapy. Although convulsions have been noted in patients taking fluvoxamine (see Incidence of Adverse Effects), a small clinical study involving 35 depressed epileptic patients found no change in the number of seizures or in their nature when fluvoxamine was given in doses of up to 200 mg daily.

Extrapyramidal effects. Extrapyramidal effects, such as tics and akathisia, have been reported with fluoxetine. By 1993, the UK CSM had received 39 reports of extrapyramidal reactions with paroxetine including 15 of dystonia of the face and mouth. Although extrapyramidal effects might occur with other SSRIs, orofacial dystonias appeared to be more common with paroxetine. However, evidence from monitoring prescriptions within the UK showed that the overall incidence of extrapyramidal effects was the same for paroxetine as for other SSRIs. Orofacial dystonias (teeth clenching) or dyskinesias (teeth grinding), resulting in severe damage to teeth and gums in many cases, have been reported in 6 patients receiving fluoxetine, fluvoxamine, paroxetine, or sertraline. The authors concluded that these adverse effects were not specific for any particular SSRI. Analysis of spontaneous adverse reaction reports received by the national pharmacovigilance centre in The Netherlands found that there had been 41 reports of extrapyramidal effects associated with the SSRIs over a period of nearly 15 years parkinsonism and dystonia were the most frequently reported effects. Over the same time period, 14 reports had been received in total for other anti-depressants. The authors commented that the results might be biased by the selective reporting of adverse reactions to the SSRIs. Dyskinesia associated with withdrawal of citalopram andrisperi-done has been reported in a patient.

The onset of akathisia may be linked to suicidal ideation for further details, see Effects on Mental State, above.

Hypersensitivity. Hypersensitivity reactions to SSRIs are well documented. Interestingly, despite structural dissimilarities, there have been a few reports of cross-sensitivity between SSRIs. A young man who had previously developed a maculopapular rash while taking paroxetine suffered a similar reaction after starting sertraline both episodes resolved after the SSRI was withdrawn.

Hyponatraemia. See Effects on the Endocrine System, above.

Overdosage. SSRIs are generally regarded as being less toxic in overdosage than tricyclic antidepressants or MAOIs. A review of SSRI overdosage, covering the period 1985 to 1997, noted that there had been remarkably few fatal overdoses when taken alone. Moderate overdoses (up to about 30 times the usual daily dose) were generally associated with minor symptoms at most only at very high doses (more than 75 times the usual daily dose) did more serious effects such as seizures, ECG abnormalities, and decreased consciousness tend to occur. Toxicity was greatly increased, however, when overdoses of SSRIs were taken with alcohol or other drugs. There was no evidence of a difference in the various SSRIs with respect to safety in overdosage. The results of a more recent cohort study have also confirmed the relative safety of the SSRIs in overdosage. However, the study also found that citalopram was potentially more cardiotox-ic than other SSRIs in overdose, causing significant prolongation of the QT interval (see below). In addition, serotonin syndrome was noted as being a common feature of SSRI overdosage although in most cases symptoms were not severe or life-threatening.

• Fatal overdose was reported with citalopram in 6 patients, although the suggested cause of death as cardiac dysfunction rather than seizures was disputed. Nonetheless, cases’ of cardiac abnormalities (including prolongation of the QT interval) associated with citalopram overdose have continued to be reported, and routine ECG monitoring may be necessary in the management of overdosage. Some authors consider that a metabolite, didemethylcitalopram, rather than citalopram itself, may be responsible for the cardiotoxicity seen with citalopram overdose. At therapeutic doses, concentrations of didemethylcitalopram are much lower than those of citalopram and, in general, significant cardiotoxicity is not seen however, in overdosage the amount of didemethylcital opram may be sufficient to induce cardiac conduction abnormalities.

• A report involving 87 cases in which fluoxetine was taken in overdosage without other drugs found that the main symptoms were tachycardia, drowsiness, tremor, and nausea and vomiting. These were considered relatively minor, and were of short duration, and supportive care was considered to be the only intervention necessary.

• Of 41 cases of self-poisoning with fluvoxamine, only one patient died and even here fluvoxamine was not implicated. Prolonged cerebral depression occurred in a patient after fluvoxamine overdose, but this may have been due to an interaction with temazepam which the patient also took in overdose.

• One hour after taking 2 g of sertraline in a suicide attempt a 42-year-old woman was flushed, angry, emotionally labile, and easily distracted but not psychotic. Apart from watery bowel movements recovery was mainly uneventful after treatment with gastric lavage, oral activated charcoal with sorbitol, and intravenous hydration. In another case, symptoms resembling serotonin syndrome developed in a 51-year-old woman after an overdose attempt with sertraline it was believed that the patient may have taken as much as 8 g of sertraline. She recovered with supportive treatment. Abnormal liver function tests have also been noted after a suicide attempt with sertraline (see Effects on the Liver, above).

For a discussion of choice of antidepressant with respect to toxicity in overdosage, see under Depression.

Treatment of Adverse Effects

Treatment of overdosage with an SSRI involves appropriate symptomatic and supportive therapy. Activated charcoal may be given by mouth if the amount ingested was large (see below) and treatment is within an hour of ingestion. Dialysis, haemoperfusion, exchange transfusion, and measures to increase urine production are considered unlikely to be of benefit.

Activated charcoal. The UK Poisons Information Service considers the benefit of gastric decontamination in the management of overdosage with SSRIs to be uncertain. However, it is suggested that oral activated charcoal may be considered if this is given within 1 hour of ingestion and the quantity of SSRI exceeds the following amount:

• citalopram: 5 mg/kg (adult) 5 mg/kg (child)

• escitalopram: 2.5 mg/kg (adult) 2.5 mg/kg (child)

• fluoxetine: 500 mg (adult) 5 mg/kg (child)

• fluvoxamine: 1 g (adult) 100 mg (child)

• paroxetine: 600 mg (adult) 5 mg/kg (child)

• sertraline: 1 g (adult) 10 mg/kg (child)