Guest guest Posted April 9, 2002 Report Share Posted April 9, 2002 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 CASRN: 54910-89-3 FLUOXETINE Administrative Information: Hazardous Substances Databank Number: 6633 Last Revision Date: 20020114 Last Review Date: Reviewed by SRP on 6/15/1992 Update History: Complete Update on 01/14/2002, Human Health Effects: Human Toxicity Excerpts: Several fatalities following fluoxetine overdosage have been reported to date. One of the deaths occurred in a patient who reportedly ingested 1.8 g of fluoxetine and an unknown quantity of maprotiline; plasma fluoxetine and maprotiline concentrations in this patient were approximately 4570 and 4180 ng/ml, respectively. Another patient died after concomitantly ingesting fluoxetine, codeine, and temazepam; plasma fluoxetine, norfluoxetine, codeine, and temazepam concentrations in this patient reportedly were 1930, 1110, 1800, and 3800 ng/ml, respectively. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1244]**PEER REVIEWED** The potential for misuse of fluoxetine by depressed patients with concurrent eating disorders and/or those who may seek the drug for its appetite suppressant effects also should be considered. One patient with an undisclosed history of anorexia nervosa and laxative abuse who was given fluoxetine for depression ingested larger-than-prescribed doses (eg, 90-120 mg/day) and lost 9.1 kg within 2 mo; this patient falsely claimed mood improvement in order to continue receiving the drug for its anorectic and weight reducing effects. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1240]**PEER REVIEWED** The most frequent adverse effect associated with fluoxetine therapy is nausea, which occurs in about 21% of patients. Nausea generally is mild, occurs early in therapy, and usually subsides after a few weeks of continued therapy with the drug. Diarrhea occurs in about 12%, anorexia in about 9%, and dyspepsia in about 6% of patients receiving the drug; limited evidence suggests that the incidence of anorexia may be dose-related. Increased appetite has been reported in more than 1% of patients receiving fluoxetine , but has not been definitely attributed to the drug. Other adverse GI effects, including aphthous stomatitis, dysphagia, eructation, esophagitis, gastritis, gingivitis, glossitis, melena, stomatitis, and thirst, have been reported in less than 1% of fluoxetine -treated patients; however, a causal relationship to the drug has not been established. Bloody diarrhea, colitis, duodenal or gastric ulcer, enteritis, fecal incontinence, hematemesis, hyperchlorhydria, increased salivation, mouth ulceration, salivary gland enlargement, tongue discoloration, and tongue edema have occurred rarely, but have not been definitely attributed to fluoxetine. . [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Rash (including maculopapular, purpuric, pustular, and vesiculobullous rash; erythema multiform) and/or uticaria occurs in about 4% and pruritus occurs in about 2% of patients receiving fluoxetine.. Adverse dermatologic effects, principally rash and pruritus, generally occur during the first few weeks of therapy and have required discontinuance of the drug in approximately 1% of patients. ... Excessive sweating occurs in about 8% of patients receiving fluoxetine. . Allergic reactions have occurred in apporoximately 1% of patients. Adverse dermatologic and hypersensitivity reactions occuring in less than 1% of patients receiving fluoxetine include acne, cyst formation, dry skin, contact dermatitis, facial edema, alopecia, and herpes simplex; however, these effects have not been definitely attributed to the drug. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1242]**PEER REVIEWED** In controlled studies, the most common adverse reactions occurring more frequently in patients receiving fluoxetine than in those receiving placebo included nervous system effects such as anxiety, nervousness, insomnia, drowsiness, fatigue or asthenia, tremor, and dizziness or lightheadedness; GI effects such as anorexia, nausea, and diarrhea; and sweating. Discontinuance of fluoxetine therapy was required in about 15% of patients, principally because of adverse psychiatric /conditions/ (eg, nervousness, anxiety, insomnia), other nervous system (eg, dizziness, asthenia, headache), GI (eg, nausea), and dermatologic (eg, rash, pruritus) effects. Because of the relatively long elimination half-lives of fluoxetine and its principal metabolite norfluoxetine, the possibility that some adverse effects may resolve slowly following discontinuance of the drug should be considered. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Headache has occurred in approximately 20% of patients receiving fluoxetine and has required discontinuance of therapy in less than 1.5% of patients. Nervousness and anxiety have occurred in about 15 and 9% of patients, respectively, and insomnia has occurred in about 14% of patients receiving the drug; such effects appear to be dose-related and have required discontinuance of therapy in approximately 5% of fluoxetine -treated patients. However, because insomnia is a symptom also associated with depression, relief of insomnia and improvement in sleep patterns may occur when clinical improvement in depression becomes apparent during antidepressant therapy. ... Drowsiness and fatigue or asthenia reportedly occur in about 12 and 4%, respectively, of patients receiving fluoxetine therapy. Tremor and dizziness have occurred in about 8 and 6% of patients, respectively; the incidence of dizziness may be dose-related. Adverse nervous system effects reportedly occurring in approximately 1-2% of patients include sedation, sensation disturbance, lightheadedness, and decreased concentration. Abnormal dreams and agitation have been reported in more than 1% of patients receiving fluoxetine therapy. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** The most frequent side effects of fluoxetine are nausea, nervousness/agitation, and insomnia (incidence 20% to 40%). However, these effects are generally mild and seldom require discontinuation of treatment. Less frequent reported reactions include headache, tremor, anxiety, drowsiness, dry mouth, sweating, and diarrhea. Small but significant weight loss sometimes occurs during the first few weeks of therapy, but it may not be sustained. With prolonged treatment, excessive sweating and anxiety have been noted most frequently. The only cardiovascular effect observed has been a slight (about 3 beats/min) decrease in heart rate. The drug has not been tested specifically in patients with cardiac disease, but it probably is safe in such patients. [American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991. 276]**PEER REVIEWED** Experience with overdose in humans is limited. One patient had two brief seizures after ingesting 3 g /of/ fluoxetine. Eight additional patients tolerated overdose of fluoxetine with minimal or no symptoms. The only reported death involved multiple additional drugs. [Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990. 651]**PEER REVIEWED** A recent report of six depressed patients who developed intense, violent suicidal preoccupation after 2 to 7 wk of fluoxetine treatment prompted the /a/ survey of 27 psychiatrists who treated 1017 depressed outpatients with antidepressants during 1989: 3.5% (8/231) of those treated with fluoxetine alone, 6.5% (4/62) of those treated with fluoxetine and tricyclics, 1.3% (5/385) of those treated with tricyclics alone or with lithium, and 3.0% (3/101) of those treated with other antidepressants became suicidal only after treatment with these antidepressants was initiated. None of these patients, however, reported intense suicidal thoughts of the degree described in the previously reported six cases. The difference in incidence of suicidal ideation occurring only after initiation of treatment was not significant between patients treated with fluoxetine alone and those receiving the other antidepressant treatments. [Fava M, Rosenbaum JF; J Clin Psychiatry 52 (3): 108-11 (1991)]**PEER REVIEWED** A possible case of serotonin syndrome in a 45 yr old depressed woman resulting from the administration of 20-40 mg/day of fluoxetine hydrochloride (Prozac), 10-20 mg 2 times/day of tranylcypromine sulfate (Parnate), and 500 mg/day of tryptophan to treat refractory depression is described. It was likely that the combination of prozac, parnate, and tryptophan increased the availability of serotonin in the CNS to produce the syndrome. The patient died and the cause of death was listed as toxic encephalopathy with multisystem failure caused by neuroleptic malignant syndrome. /Fluoxetine hydrochloride (Prozac)/ [Kline SS et al; Clin Pharm 8 (July): 510-4 (1989)]**PEER REVIEWED** The cases of 2 patients with a history of depression, who had suicidal ideation while being treated with fluoxetine, are briefly presented. A 58 yr old man was admitted to a hospital for treatment for depression and began receiving 20 mg of fluoxetine /day. Three days later he attempted suicide. The fluoxetine was discontinued, with complete disappearance of suicidal ideation 4 days later. A 28 yr old woman, who had been treated for 2 mo with 20 mg of fluoxetine/day, was admitted to the hospital and the fluoxetine dosage was increased to 60 mg/day. Over the next week she had recurrent suicidal thoughts. When fluoxetine was discontinued her suicidal thoughts ceased in 10 days. It was concluded that fluoxetine can induce suicidal ideation in a very small minority of patients who do not have a diagnosable personality disorder or history of suicidal ideation, gestures, mania or hypomania. [Masand P et al; N Engl J Med 324 (Feb 7): 420 (1991)]**PEER REVIEWED** The response to and management of an acute ingestion of a large quantity of fluoxetine hydrochloride in a 13 year old boy with Tourette's syndrome and obsessive compulsive disorder is described. The patient's symptomatic course following the ingestion included a grand mal seizure, depressed ST segments on EKG, nausea, dizziness, and headache. In general, the fluoxetine was well tolerated: all of the symptoms and signs remitted spontaneously. /Fluoxetine hydrochloride/ [Riddle MA et al; J Am Acad Child Adolesc Psychiatry 28 (4): 587-8 (1989)]**PEER REVIEWED** Several fatalities due to fluoxetine combined with other drugs such as ethyl alcohol have been reported. An apparent suicide in which fluoxetine was the only causative agent was reported. Because this drug is widely described as having a wide safety margin, it is important to note concentrations in blood associated with overdose fatalities. The findings by GC/NPD and GC/MS in blood were as follows: fluoxetine 6000 ng/ml and demethylated metabolite 5000 ng/ml. Parent compound and metabolite were 13000 ng/ml each in bile. [Kincaid RL et al; J Anal Toxicol 14 (5)P: 327-9 (1990)]**PEER REVIEWED** Self-injurious ideation or behavior appeared de novo or intensified during fluoxetine treatment of obsessive-compulsive disorder in six patients, age 10 to 17 years old, who were among 42 young patients receiving fluoxetine for obsessive-compulsive disorder at a university clinical research center. These symptoms required the hospitalization of four patients. Before receiving fluoxetine, four patients had major risk factors for self-destructive behavior including depression or prior suicidal ideation or self-injury. Three hypotheses concerning the apparent association between fluoxetine and these self-injurious phenomena are discussed: (1) coincidence; (2) disorganization of vulnerable individuals secondary to drug-induced activation; and (3) a specific serotonergic-mediated effect on the regulation of aggression. [King RA et al; J Am Acad Child Adolesc Psychiatry 30 (2): 179-86 (1991)]**PEER REVIEWED** Treatment with 5HT reuptake inhibitors /such as fluoxetine/ has been shown to attenuate ethanol consumption in both animals and humans. [Durcan MJ et al; Adv Alcohol Subst Abuse 7 (3-4): 113-7 (1988)]**PEER REVIEWED** Drug Warnings: Because of the possibility of suicide in depressed patients, close supervision of high risk patients is recommended during initial fluoxetine therapy. To reduce the risk of overdosage, the drug should be prescribed in the smallest quantity consisted with good patient management. Suicidal ideation may persist until substantial remission of the depressive disorder occurs. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1243]**PEER REVIEWED** Risk-benefit should be considered when the following medical problems exist (reasons given where appropriate): Diabetes mellitus (glycemic control may be altered); Hepatic function impairment (metabolism of fluoxetine is delayed; lower doses or less frequent dosing is recommended in patients with liver disease); Renal function impairment (excretion of fluoxetine may be delayed; lower doses or less frequent dosing is recommended in patients with renal disease); History of seizures disorders (seizures may be induced by fluoxetine in patients with a history of seizure disorders). [uSPDI; Drug Information for the Health Care Professional 12 ed V. IA p.1421 (1992)]**PEER REVIEWED** Drugs whose Effect on Nursing Infants is Unknown but may be of Concern: Fluoxetine: None. /from Table 4/ [Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 139 (1994)]**QC REVIEWED** _________________________________________________________________ Join the world’s largest e-mail service with MSN Hotmail. http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 9, 2002 Report Share Posted April 9, 2002 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 CASRN: 54910-89-3 FLUOXETINE Administrative Information: Hazardous Substances Databank Number: 6633 Last Revision Date: 20020114 Last Review Date: Reviewed by SRP on 6/15/1992 Update History: Complete Update on 01/14/2002, Human Health Effects: Human Toxicity Excerpts: Several fatalities following fluoxetine overdosage have been reported to date. One of the deaths occurred in a patient who reportedly ingested 1.8 g of fluoxetine and an unknown quantity of maprotiline; plasma fluoxetine and maprotiline concentrations in this patient were approximately 4570 and 4180 ng/ml, respectively. Another patient died after concomitantly ingesting fluoxetine, codeine, and temazepam; plasma fluoxetine, norfluoxetine, codeine, and temazepam concentrations in this patient reportedly were 1930, 1110, 1800, and 3800 ng/ml, respectively. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1244]**PEER REVIEWED** The potential for misuse of fluoxetine by depressed patients with concurrent eating disorders and/or those who may seek the drug for its appetite suppressant effects also should be considered. One patient with an undisclosed history of anorexia nervosa and laxative abuse who was given fluoxetine for depression ingested larger-than-prescribed doses (eg, 90-120 mg/day) and lost 9.1 kg within 2 mo; this patient falsely claimed mood improvement in order to continue receiving the drug for its anorectic and weight reducing effects. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1240]**PEER REVIEWED** The most frequent adverse effect associated with fluoxetine therapy is nausea, which occurs in about 21% of patients. Nausea generally is mild, occurs early in therapy, and usually subsides after a few weeks of continued therapy with the drug. Diarrhea occurs in about 12%, anorexia in about 9%, and dyspepsia in about 6% of patients receiving the drug; limited evidence suggests that the incidence of anorexia may be dose-related. Increased appetite has been reported in more than 1% of patients receiving fluoxetine , but has not been definitely attributed to the drug. Other adverse GI effects, including aphthous stomatitis, dysphagia, eructation, esophagitis, gastritis, gingivitis, glossitis, melena, stomatitis, and thirst, have been reported in less than 1% of fluoxetine -treated patients; however, a causal relationship to the drug has not been established. Bloody diarrhea, colitis, duodenal or gastric ulcer, enteritis, fecal incontinence, hematemesis, hyperchlorhydria, increased salivation, mouth ulceration, salivary gland enlargement, tongue discoloration, and tongue edema have occurred rarely, but have not been definitely attributed to fluoxetine. . [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Rash (including maculopapular, purpuric, pustular, and vesiculobullous rash; erythema multiform) and/or uticaria occurs in about 4% and pruritus occurs in about 2% of patients receiving fluoxetine.. Adverse dermatologic effects, principally rash and pruritus, generally occur during the first few weeks of therapy and have required discontinuance of the drug in approximately 1% of patients. ... Excessive sweating occurs in about 8% of patients receiving fluoxetine. . Allergic reactions have occurred in apporoximately 1% of patients. Adverse dermatologic and hypersensitivity reactions occuring in less than 1% of patients receiving fluoxetine include acne, cyst formation, dry skin, contact dermatitis, facial edema, alopecia, and herpes simplex; however, these effects have not been definitely attributed to the drug. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1242]**PEER REVIEWED** In controlled studies, the most common adverse reactions occurring more frequently in patients receiving fluoxetine than in those receiving placebo included nervous system effects such as anxiety, nervousness, insomnia, drowsiness, fatigue or asthenia, tremor, and dizziness or lightheadedness; GI effects such as anorexia, nausea, and diarrhea; and sweating. Discontinuance of fluoxetine therapy was required in about 15% of patients, principally because of adverse psychiatric /conditions/ (eg, nervousness, anxiety, insomnia), other nervous system (eg, dizziness, asthenia, headache), GI (eg, nausea), and dermatologic (eg, rash, pruritus) effects. Because of the relatively long elimination half-lives of fluoxetine and its principal metabolite norfluoxetine, the possibility that some adverse effects may resolve slowly following discontinuance of the drug should be considered. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Headache has occurred in approximately 20% of patients receiving fluoxetine and has required discontinuance of therapy in less than 1.5% of patients. Nervousness and anxiety have occurred in about 15 and 9% of patients, respectively, and insomnia has occurred in about 14% of patients receiving the drug; such effects appear to be dose-related and have required discontinuance of therapy in approximately 5% of fluoxetine -treated patients. However, because insomnia is a symptom also associated with depression, relief of insomnia and improvement in sleep patterns may occur when clinical improvement in depression becomes apparent during antidepressant therapy. ... Drowsiness and fatigue or asthenia reportedly occur in about 12 and 4%, respectively, of patients receiving fluoxetine therapy. Tremor and dizziness have occurred in about 8 and 6% of patients, respectively; the incidence of dizziness may be dose-related. Adverse nervous system effects reportedly occurring in approximately 1-2% of patients include sedation, sensation disturbance, lightheadedness, and decreased concentration. Abnormal dreams and agitation have been reported in more than 1% of patients receiving fluoxetine therapy. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** The most frequent side effects of fluoxetine are nausea, nervousness/agitation, and insomnia (incidence 20% to 40%). However, these effects are generally mild and seldom require discontinuation of treatment. Less frequent reported reactions include headache, tremor, anxiety, drowsiness, dry mouth, sweating, and diarrhea. Small but significant weight loss sometimes occurs during the first few weeks of therapy, but it may not be sustained. With prolonged treatment, excessive sweating and anxiety have been noted most frequently. The only cardiovascular effect observed has been a slight (about 3 beats/min) decrease in heart rate. The drug has not been tested specifically in patients with cardiac disease, but it probably is safe in such patients. [American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991. 276]**PEER REVIEWED** Experience with overdose in humans is limited. One patient had two brief seizures after ingesting 3 g /of/ fluoxetine. Eight additional patients tolerated overdose of fluoxetine with minimal or no symptoms. The only reported death involved multiple additional drugs. [Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990. 651]**PEER REVIEWED** A recent report of six depressed patients who developed intense, violent suicidal preoccupation after 2 to 7 wk of fluoxetine treatment prompted the /a/ survey of 27 psychiatrists who treated 1017 depressed outpatients with antidepressants during 1989: 3.5% (8/231) of those treated with fluoxetine alone, 6.5% (4/62) of those treated with fluoxetine and tricyclics, 1.3% (5/385) of those treated with tricyclics alone or with lithium, and 3.0% (3/101) of those treated with other antidepressants became suicidal only after treatment with these antidepressants was initiated. None of these patients, however, reported intense suicidal thoughts of the degree described in the previously reported six cases. The difference in incidence of suicidal ideation occurring only after initiation of treatment was not significant between patients treated with fluoxetine alone and those receiving the other antidepressant treatments. [Fava M, Rosenbaum JF; J Clin Psychiatry 52 (3): 108-11 (1991)]**PEER REVIEWED** A possible case of serotonin syndrome in a 45 yr old depressed woman resulting from the administration of 20-40 mg/day of fluoxetine hydrochloride (Prozac), 10-20 mg 2 times/day of tranylcypromine sulfate (Parnate), and 500 mg/day of tryptophan to treat refractory depression is described. It was likely that the combination of prozac, parnate, and tryptophan increased the availability of serotonin in the CNS to produce the syndrome. The patient died and the cause of death was listed as toxic encephalopathy with multisystem failure caused by neuroleptic malignant syndrome. /Fluoxetine hydrochloride (Prozac)/ [Kline SS et al; Clin Pharm 8 (July): 510-4 (1989)]**PEER REVIEWED** The cases of 2 patients with a history of depression, who had suicidal ideation while being treated with fluoxetine, are briefly presented. A 58 yr old man was admitted to a hospital for treatment for depression and began receiving 20 mg of fluoxetine /day. Three days later he attempted suicide. The fluoxetine was discontinued, with complete disappearance of suicidal ideation 4 days later. A 28 yr old woman, who had been treated for 2 mo with 20 mg of fluoxetine/day, was admitted to the hospital and the fluoxetine dosage was increased to 60 mg/day. Over the next week she had recurrent suicidal thoughts. When fluoxetine was discontinued her suicidal thoughts ceased in 10 days. It was concluded that fluoxetine can induce suicidal ideation in a very small minority of patients who do not have a diagnosable personality disorder or history of suicidal ideation, gestures, mania or hypomania. [Masand P et al; N Engl J Med 324 (Feb 7): 420 (1991)]**PEER REVIEWED** The response to and management of an acute ingestion of a large quantity of fluoxetine hydrochloride in a 13 year old boy with Tourette's syndrome and obsessive compulsive disorder is described. The patient's symptomatic course following the ingestion included a grand mal seizure, depressed ST segments on EKG, nausea, dizziness, and headache. In general, the fluoxetine was well tolerated: all of the symptoms and signs remitted spontaneously. /Fluoxetine hydrochloride/ [Riddle MA et al; J Am Acad Child Adolesc Psychiatry 28 (4): 587-8 (1989)]**PEER REVIEWED** Several fatalities due to fluoxetine combined with other drugs such as ethyl alcohol have been reported. An apparent suicide in which fluoxetine was the only causative agent was reported. Because this drug is widely described as having a wide safety margin, it is important to note concentrations in blood associated with overdose fatalities. The findings by GC/NPD and GC/MS in blood were as follows: fluoxetine 6000 ng/ml and demethylated metabolite 5000 ng/ml. Parent compound and metabolite were 13000 ng/ml each in bile. [Kincaid RL et al; J Anal Toxicol 14 (5)P: 327-9 (1990)]**PEER REVIEWED** Self-injurious ideation or behavior appeared de novo or intensified during fluoxetine treatment of obsessive-compulsive disorder in six patients, age 10 to 17 years old, who were among 42 young patients receiving fluoxetine for obsessive-compulsive disorder at a university clinical research center. These symptoms required the hospitalization of four patients. Before receiving fluoxetine, four patients had major risk factors for self-destructive behavior including depression or prior suicidal ideation or self-injury. Three hypotheses concerning the apparent association between fluoxetine and these self-injurious phenomena are discussed: (1) coincidence; (2) disorganization of vulnerable individuals secondary to drug-induced activation; and (3) a specific serotonergic-mediated effect on the regulation of aggression. [King RA et al; J Am Acad Child Adolesc Psychiatry 30 (2): 179-86 (1991)]**PEER REVIEWED** Treatment with 5HT reuptake inhibitors /such as fluoxetine/ has been shown to attenuate ethanol consumption in both animals and humans. [Durcan MJ et al; Adv Alcohol Subst Abuse 7 (3-4): 113-7 (1988)]**PEER REVIEWED** Drug Warnings: Because of the possibility of suicide in depressed patients, close supervision of high risk patients is recommended during initial fluoxetine therapy. To reduce the risk of overdosage, the drug should be prescribed in the smallest quantity consisted with good patient management. Suicidal ideation may persist until substantial remission of the depressive disorder occurs. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1243]**PEER REVIEWED** Risk-benefit should be considered when the following medical problems exist (reasons given where appropriate): Diabetes mellitus (glycemic control may be altered); Hepatic function impairment (metabolism of fluoxetine is delayed; lower doses or less frequent dosing is recommended in patients with liver disease); Renal function impairment (excretion of fluoxetine may be delayed; lower doses or less frequent dosing is recommended in patients with renal disease); History of seizures disorders (seizures may be induced by fluoxetine in patients with a history of seizure disorders). [uSPDI; Drug Information for the Health Care Professional 12 ed V. IA p.1421 (1992)]**PEER REVIEWED** Drugs whose Effect on Nursing Infants is Unknown but may be of Concern: Fluoxetine: None. /from Table 4/ [Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 139 (1994)]**QC REVIEWED** _________________________________________________________________ Join the world’s largest e-mail service with MSN Hotmail. http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 9, 2002 Report Share Posted April 9, 2002 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 CASRN: 54910-89-3 FLUOXETINE Administrative Information: Hazardous Substances Databank Number: 6633 Last Revision Date: 20020114 Last Review Date: Reviewed by SRP on 6/15/1992 Update History: Complete Update on 01/14/2002, Human Health Effects: Human Toxicity Excerpts: Several fatalities following fluoxetine overdosage have been reported to date. One of the deaths occurred in a patient who reportedly ingested 1.8 g of fluoxetine and an unknown quantity of maprotiline; plasma fluoxetine and maprotiline concentrations in this patient were approximately 4570 and 4180 ng/ml, respectively. Another patient died after concomitantly ingesting fluoxetine, codeine, and temazepam; plasma fluoxetine, norfluoxetine, codeine, and temazepam concentrations in this patient reportedly were 1930, 1110, 1800, and 3800 ng/ml, respectively. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1244]**PEER REVIEWED** The potential for misuse of fluoxetine by depressed patients with concurrent eating disorders and/or those who may seek the drug for its appetite suppressant effects also should be considered. One patient with an undisclosed history of anorexia nervosa and laxative abuse who was given fluoxetine for depression ingested larger-than-prescribed doses (eg, 90-120 mg/day) and lost 9.1 kg within 2 mo; this patient falsely claimed mood improvement in order to continue receiving the drug for its anorectic and weight reducing effects. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1240]**PEER REVIEWED** The most frequent adverse effect associated with fluoxetine therapy is nausea, which occurs in about 21% of patients. Nausea generally is mild, occurs early in therapy, and usually subsides after a few weeks of continued therapy with the drug. Diarrhea occurs in about 12%, anorexia in about 9%, and dyspepsia in about 6% of patients receiving the drug; limited evidence suggests that the incidence of anorexia may be dose-related. Increased appetite has been reported in more than 1% of patients receiving fluoxetine , but has not been definitely attributed to the drug. Other adverse GI effects, including aphthous stomatitis, dysphagia, eructation, esophagitis, gastritis, gingivitis, glossitis, melena, stomatitis, and thirst, have been reported in less than 1% of fluoxetine -treated patients; however, a causal relationship to the drug has not been established. Bloody diarrhea, colitis, duodenal or gastric ulcer, enteritis, fecal incontinence, hematemesis, hyperchlorhydria, increased salivation, mouth ulceration, salivary gland enlargement, tongue discoloration, and tongue edema have occurred rarely, but have not been definitely attributed to fluoxetine. . [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Rash (including maculopapular, purpuric, pustular, and vesiculobullous rash; erythema multiform) and/or uticaria occurs in about 4% and pruritus occurs in about 2% of patients receiving fluoxetine.. Adverse dermatologic effects, principally rash and pruritus, generally occur during the first few weeks of therapy and have required discontinuance of the drug in approximately 1% of patients. ... Excessive sweating occurs in about 8% of patients receiving fluoxetine. . Allergic reactions have occurred in apporoximately 1% of patients. Adverse dermatologic and hypersensitivity reactions occuring in less than 1% of patients receiving fluoxetine include acne, cyst formation, dry skin, contact dermatitis, facial edema, alopecia, and herpes simplex; however, these effects have not been definitely attributed to the drug. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1242]**PEER REVIEWED** In controlled studies, the most common adverse reactions occurring more frequently in patients receiving fluoxetine than in those receiving placebo included nervous system effects such as anxiety, nervousness, insomnia, drowsiness, fatigue or asthenia, tremor, and dizziness or lightheadedness; GI effects such as anorexia, nausea, and diarrhea; and sweating. Discontinuance of fluoxetine therapy was required in about 15% of patients, principally because of adverse psychiatric /conditions/ (eg, nervousness, anxiety, insomnia), other nervous system (eg, dizziness, asthenia, headache), GI (eg, nausea), and dermatologic (eg, rash, pruritus) effects. Because of the relatively long elimination half-lives of fluoxetine and its principal metabolite norfluoxetine, the possibility that some adverse effects may resolve slowly following discontinuance of the drug should be considered. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Headache has occurred in approximately 20% of patients receiving fluoxetine and has required discontinuance of therapy in less than 1.5% of patients. Nervousness and anxiety have occurred in about 15 and 9% of patients, respectively, and insomnia has occurred in about 14% of patients receiving the drug; such effects appear to be dose-related and have required discontinuance of therapy in approximately 5% of fluoxetine -treated patients. However, because insomnia is a symptom also associated with depression, relief of insomnia and improvement in sleep patterns may occur when clinical improvement in depression becomes apparent during antidepressant therapy. ... Drowsiness and fatigue or asthenia reportedly occur in about 12 and 4%, respectively, of patients receiving fluoxetine therapy. Tremor and dizziness have occurred in about 8 and 6% of patients, respectively; the incidence of dizziness may be dose-related. Adverse nervous system effects reportedly occurring in approximately 1-2% of patients include sedation, sensation disturbance, lightheadedness, and decreased concentration. Abnormal dreams and agitation have been reported in more than 1% of patients receiving fluoxetine therapy. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** The most frequent side effects of fluoxetine are nausea, nervousness/agitation, and insomnia (incidence 20% to 40%). However, these effects are generally mild and seldom require discontinuation of treatment. Less frequent reported reactions include headache, tremor, anxiety, drowsiness, dry mouth, sweating, and diarrhea. Small but significant weight loss sometimes occurs during the first few weeks of therapy, but it may not be sustained. With prolonged treatment, excessive sweating and anxiety have been noted most frequently. The only cardiovascular effect observed has been a slight (about 3 beats/min) decrease in heart rate. The drug has not been tested specifically in patients with cardiac disease, but it probably is safe in such patients. [American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991. 276]**PEER REVIEWED** Experience with overdose in humans is limited. One patient had two brief seizures after ingesting 3 g /of/ fluoxetine. Eight additional patients tolerated overdose of fluoxetine with minimal or no symptoms. The only reported death involved multiple additional drugs. [Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990. 651]**PEER REVIEWED** A recent report of six depressed patients who developed intense, violent suicidal preoccupation after 2 to 7 wk of fluoxetine treatment prompted the /a/ survey of 27 psychiatrists who treated 1017 depressed outpatients with antidepressants during 1989: 3.5% (8/231) of those treated with fluoxetine alone, 6.5% (4/62) of those treated with fluoxetine and tricyclics, 1.3% (5/385) of those treated with tricyclics alone or with lithium, and 3.0% (3/101) of those treated with other antidepressants became suicidal only after treatment with these antidepressants was initiated. None of these patients, however, reported intense suicidal thoughts of the degree described in the previously reported six cases. The difference in incidence of suicidal ideation occurring only after initiation of treatment was not significant between patients treated with fluoxetine alone and those receiving the other antidepressant treatments. [Fava M, Rosenbaum JF; J Clin Psychiatry 52 (3): 108-11 (1991)]**PEER REVIEWED** A possible case of serotonin syndrome in a 45 yr old depressed woman resulting from the administration of 20-40 mg/day of fluoxetine hydrochloride (Prozac), 10-20 mg 2 times/day of tranylcypromine sulfate (Parnate), and 500 mg/day of tryptophan to treat refractory depression is described. It was likely that the combination of prozac, parnate, and tryptophan increased the availability of serotonin in the CNS to produce the syndrome. The patient died and the cause of death was listed as toxic encephalopathy with multisystem failure caused by neuroleptic malignant syndrome. /Fluoxetine hydrochloride (Prozac)/ [Kline SS et al; Clin Pharm 8 (July): 510-4 (1989)]**PEER REVIEWED** The cases of 2 patients with a history of depression, who had suicidal ideation while being treated with fluoxetine, are briefly presented. A 58 yr old man was admitted to a hospital for treatment for depression and began receiving 20 mg of fluoxetine /day. Three days later he attempted suicide. The fluoxetine was discontinued, with complete disappearance of suicidal ideation 4 days later. A 28 yr old woman, who had been treated for 2 mo with 20 mg of fluoxetine/day, was admitted to the hospital and the fluoxetine dosage was increased to 60 mg/day. Over the next week she had recurrent suicidal thoughts. When fluoxetine was discontinued her suicidal thoughts ceased in 10 days. It was concluded that fluoxetine can induce suicidal ideation in a very small minority of patients who do not have a diagnosable personality disorder or history of suicidal ideation, gestures, mania or hypomania. [Masand P et al; N Engl J Med 324 (Feb 7): 420 (1991)]**PEER REVIEWED** The response to and management of an acute ingestion of a large quantity of fluoxetine hydrochloride in a 13 year old boy with Tourette's syndrome and obsessive compulsive disorder is described. The patient's symptomatic course following the ingestion included a grand mal seizure, depressed ST segments on EKG, nausea, dizziness, and headache. In general, the fluoxetine was well tolerated: all of the symptoms and signs remitted spontaneously. /Fluoxetine hydrochloride/ [Riddle MA et al; J Am Acad Child Adolesc Psychiatry 28 (4): 587-8 (1989)]**PEER REVIEWED** Several fatalities due to fluoxetine combined with other drugs such as ethyl alcohol have been reported. An apparent suicide in which fluoxetine was the only causative agent was reported. Because this drug is widely described as having a wide safety margin, it is important to note concentrations in blood associated with overdose fatalities. The findings by GC/NPD and GC/MS in blood were as follows: fluoxetine 6000 ng/ml and demethylated metabolite 5000 ng/ml. Parent compound and metabolite were 13000 ng/ml each in bile. [Kincaid RL et al; J Anal Toxicol 14 (5)P: 327-9 (1990)]**PEER REVIEWED** Self-injurious ideation or behavior appeared de novo or intensified during fluoxetine treatment of obsessive-compulsive disorder in six patients, age 10 to 17 years old, who were among 42 young patients receiving fluoxetine for obsessive-compulsive disorder at a university clinical research center. These symptoms required the hospitalization of four patients. Before receiving fluoxetine, four patients had major risk factors for self-destructive behavior including depression or prior suicidal ideation or self-injury. Three hypotheses concerning the apparent association between fluoxetine and these self-injurious phenomena are discussed: (1) coincidence; (2) disorganization of vulnerable individuals secondary to drug-induced activation; and (3) a specific serotonergic-mediated effect on the regulation of aggression. [King RA et al; J Am Acad Child Adolesc Psychiatry 30 (2): 179-86 (1991)]**PEER REVIEWED** Treatment with 5HT reuptake inhibitors /such as fluoxetine/ has been shown to attenuate ethanol consumption in both animals and humans. [Durcan MJ et al; Adv Alcohol Subst Abuse 7 (3-4): 113-7 (1988)]**PEER REVIEWED** Drug Warnings: Because of the possibility of suicide in depressed patients, close supervision of high risk patients is recommended during initial fluoxetine therapy. To reduce the risk of overdosage, the drug should be prescribed in the smallest quantity consisted with good patient management. Suicidal ideation may persist until substantial remission of the depressive disorder occurs. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1243]**PEER REVIEWED** Risk-benefit should be considered when the following medical problems exist (reasons given where appropriate): Diabetes mellitus (glycemic control may be altered); Hepatic function impairment (metabolism of fluoxetine is delayed; lower doses or less frequent dosing is recommended in patients with liver disease); Renal function impairment (excretion of fluoxetine may be delayed; lower doses or less frequent dosing is recommended in patients with renal disease); History of seizures disorders (seizures may be induced by fluoxetine in patients with a history of seizure disorders). [uSPDI; Drug Information for the Health Care Professional 12 ed V. IA p.1421 (1992)]**PEER REVIEWED** Drugs whose Effect on Nursing Infants is Unknown but may be of Concern: Fluoxetine: None. /from Table 4/ [Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 139 (1994)]**QC REVIEWED** _________________________________________________________________ Join the world’s largest e-mail service with MSN Hotmail. http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 9, 2002 Report Share Posted April 9, 2002 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 CASRN: 54910-89-3 FLUOXETINE Administrative Information: Hazardous Substances Databank Number: 6633 Last Revision Date: 20020114 Last Review Date: Reviewed by SRP on 6/15/1992 Update History: Complete Update on 01/14/2002, Human Health Effects: Human Toxicity Excerpts: Several fatalities following fluoxetine overdosage have been reported to date. One of the deaths occurred in a patient who reportedly ingested 1.8 g of fluoxetine and an unknown quantity of maprotiline; plasma fluoxetine and maprotiline concentrations in this patient were approximately 4570 and 4180 ng/ml, respectively. Another patient died after concomitantly ingesting fluoxetine, codeine, and temazepam; plasma fluoxetine, norfluoxetine, codeine, and temazepam concentrations in this patient reportedly were 1930, 1110, 1800, and 3800 ng/ml, respectively. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1244]**PEER REVIEWED** The potential for misuse of fluoxetine by depressed patients with concurrent eating disorders and/or those who may seek the drug for its appetite suppressant effects also should be considered. One patient with an undisclosed history of anorexia nervosa and laxative abuse who was given fluoxetine for depression ingested larger-than-prescribed doses (eg, 90-120 mg/day) and lost 9.1 kg within 2 mo; this patient falsely claimed mood improvement in order to continue receiving the drug for its anorectic and weight reducing effects. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1240]**PEER REVIEWED** The most frequent adverse effect associated with fluoxetine therapy is nausea, which occurs in about 21% of patients. Nausea generally is mild, occurs early in therapy, and usually subsides after a few weeks of continued therapy with the drug. Diarrhea occurs in about 12%, anorexia in about 9%, and dyspepsia in about 6% of patients receiving the drug; limited evidence suggests that the incidence of anorexia may be dose-related. Increased appetite has been reported in more than 1% of patients receiving fluoxetine , but has not been definitely attributed to the drug. Other adverse GI effects, including aphthous stomatitis, dysphagia, eructation, esophagitis, gastritis, gingivitis, glossitis, melena, stomatitis, and thirst, have been reported in less than 1% of fluoxetine -treated patients; however, a causal relationship to the drug has not been established. Bloody diarrhea, colitis, duodenal or gastric ulcer, enteritis, fecal incontinence, hematemesis, hyperchlorhydria, increased salivation, mouth ulceration, salivary gland enlargement, tongue discoloration, and tongue edema have occurred rarely, but have not been definitely attributed to fluoxetine. . [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Rash (including maculopapular, purpuric, pustular, and vesiculobullous rash; erythema multiform) and/or uticaria occurs in about 4% and pruritus occurs in about 2% of patients receiving fluoxetine.. Adverse dermatologic effects, principally rash and pruritus, generally occur during the first few weeks of therapy and have required discontinuance of the drug in approximately 1% of patients. ... Excessive sweating occurs in about 8% of patients receiving fluoxetine. . Allergic reactions have occurred in apporoximately 1% of patients. Adverse dermatologic and hypersensitivity reactions occuring in less than 1% of patients receiving fluoxetine include acne, cyst formation, dry skin, contact dermatitis, facial edema, alopecia, and herpes simplex; however, these effects have not been definitely attributed to the drug. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1242]**PEER REVIEWED** In controlled studies, the most common adverse reactions occurring more frequently in patients receiving fluoxetine than in those receiving placebo included nervous system effects such as anxiety, nervousness, insomnia, drowsiness, fatigue or asthenia, tremor, and dizziness or lightheadedness; GI effects such as anorexia, nausea, and diarrhea; and sweating. Discontinuance of fluoxetine therapy was required in about 15% of patients, principally because of adverse psychiatric /conditions/ (eg, nervousness, anxiety, insomnia), other nervous system (eg, dizziness, asthenia, headache), GI (eg, nausea), and dermatologic (eg, rash, pruritus) effects. Because of the relatively long elimination half-lives of fluoxetine and its principal metabolite norfluoxetine, the possibility that some adverse effects may resolve slowly following discontinuance of the drug should be considered. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** Headache has occurred in approximately 20% of patients receiving fluoxetine and has required discontinuance of therapy in less than 1.5% of patients. Nervousness and anxiety have occurred in about 15 and 9% of patients, respectively, and insomnia has occurred in about 14% of patients receiving the drug; such effects appear to be dose-related and have required discontinuance of therapy in approximately 5% of fluoxetine -treated patients. However, because insomnia is a symptom also associated with depression, relief of insomnia and improvement in sleep patterns may occur when clinical improvement in depression becomes apparent during antidepressant therapy. ... Drowsiness and fatigue or asthenia reportedly occur in about 12 and 4%, respectively, of patients receiving fluoxetine therapy. Tremor and dizziness have occurred in about 8 and 6% of patients, respectively; the incidence of dizziness may be dose-related. Adverse nervous system effects reportedly occurring in approximately 1-2% of patients include sedation, sensation disturbance, lightheadedness, and decreased concentration. Abnormal dreams and agitation have been reported in more than 1% of patients receiving fluoxetine therapy. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1241]**PEER REVIEWED** The most frequent side effects of fluoxetine are nausea, nervousness/agitation, and insomnia (incidence 20% to 40%). However, these effects are generally mild and seldom require discontinuation of treatment. Less frequent reported reactions include headache, tremor, anxiety, drowsiness, dry mouth, sweating, and diarrhea. Small but significant weight loss sometimes occurs during the first few weeks of therapy, but it may not be sustained. With prolonged treatment, excessive sweating and anxiety have been noted most frequently. The only cardiovascular effect observed has been a slight (about 3 beats/min) decrease in heart rate. The drug has not been tested specifically in patients with cardiac disease, but it probably is safe in such patients. [American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991. 276]**PEER REVIEWED** Experience with overdose in humans is limited. One patient had two brief seizures after ingesting 3 g /of/ fluoxetine. Eight additional patients tolerated overdose of fluoxetine with minimal or no symptoms. The only reported death involved multiple additional drugs. [Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990. 651]**PEER REVIEWED** A recent report of six depressed patients who developed intense, violent suicidal preoccupation after 2 to 7 wk of fluoxetine treatment prompted the /a/ survey of 27 psychiatrists who treated 1017 depressed outpatients with antidepressants during 1989: 3.5% (8/231) of those treated with fluoxetine alone, 6.5% (4/62) of those treated with fluoxetine and tricyclics, 1.3% (5/385) of those treated with tricyclics alone or with lithium, and 3.0% (3/101) of those treated with other antidepressants became suicidal only after treatment with these antidepressants was initiated. None of these patients, however, reported intense suicidal thoughts of the degree described in the previously reported six cases. The difference in incidence of suicidal ideation occurring only after initiation of treatment was not significant between patients treated with fluoxetine alone and those receiving the other antidepressant treatments. [Fava M, Rosenbaum JF; J Clin Psychiatry 52 (3): 108-11 (1991)]**PEER REVIEWED** A possible case of serotonin syndrome in a 45 yr old depressed woman resulting from the administration of 20-40 mg/day of fluoxetine hydrochloride (Prozac), 10-20 mg 2 times/day of tranylcypromine sulfate (Parnate), and 500 mg/day of tryptophan to treat refractory depression is described. It was likely that the combination of prozac, parnate, and tryptophan increased the availability of serotonin in the CNS to produce the syndrome. The patient died and the cause of death was listed as toxic encephalopathy with multisystem failure caused by neuroleptic malignant syndrome. /Fluoxetine hydrochloride (Prozac)/ [Kline SS et al; Clin Pharm 8 (July): 510-4 (1989)]**PEER REVIEWED** The cases of 2 patients with a history of depression, who had suicidal ideation while being treated with fluoxetine, are briefly presented. A 58 yr old man was admitted to a hospital for treatment for depression and began receiving 20 mg of fluoxetine /day. Three days later he attempted suicide. The fluoxetine was discontinued, with complete disappearance of suicidal ideation 4 days later. A 28 yr old woman, who had been treated for 2 mo with 20 mg of fluoxetine/day, was admitted to the hospital and the fluoxetine dosage was increased to 60 mg/day. Over the next week she had recurrent suicidal thoughts. When fluoxetine was discontinued her suicidal thoughts ceased in 10 days. It was concluded that fluoxetine can induce suicidal ideation in a very small minority of patients who do not have a diagnosable personality disorder or history of suicidal ideation, gestures, mania or hypomania. [Masand P et al; N Engl J Med 324 (Feb 7): 420 (1991)]**PEER REVIEWED** The response to and management of an acute ingestion of a large quantity of fluoxetine hydrochloride in a 13 year old boy with Tourette's syndrome and obsessive compulsive disorder is described. The patient's symptomatic course following the ingestion included a grand mal seizure, depressed ST segments on EKG, nausea, dizziness, and headache. In general, the fluoxetine was well tolerated: all of the symptoms and signs remitted spontaneously. /Fluoxetine hydrochloride/ [Riddle MA et al; J Am Acad Child Adolesc Psychiatry 28 (4): 587-8 (1989)]**PEER REVIEWED** Several fatalities due to fluoxetine combined with other drugs such as ethyl alcohol have been reported. An apparent suicide in which fluoxetine was the only causative agent was reported. Because this drug is widely described as having a wide safety margin, it is important to note concentrations in blood associated with overdose fatalities. The findings by GC/NPD and GC/MS in blood were as follows: fluoxetine 6000 ng/ml and demethylated metabolite 5000 ng/ml. Parent compound and metabolite were 13000 ng/ml each in bile. [Kincaid RL et al; J Anal Toxicol 14 (5)P: 327-9 (1990)]**PEER REVIEWED** Self-injurious ideation or behavior appeared de novo or intensified during fluoxetine treatment of obsessive-compulsive disorder in six patients, age 10 to 17 years old, who were among 42 young patients receiving fluoxetine for obsessive-compulsive disorder at a university clinical research center. These symptoms required the hospitalization of four patients. Before receiving fluoxetine, four patients had major risk factors for self-destructive behavior including depression or prior suicidal ideation or self-injury. Three hypotheses concerning the apparent association between fluoxetine and these self-injurious phenomena are discussed: (1) coincidence; (2) disorganization of vulnerable individuals secondary to drug-induced activation; and (3) a specific serotonergic-mediated effect on the regulation of aggression. [King RA et al; J Am Acad Child Adolesc Psychiatry 30 (2): 179-86 (1991)]**PEER REVIEWED** Treatment with 5HT reuptake inhibitors /such as fluoxetine/ has been shown to attenuate ethanol consumption in both animals and humans. [Durcan MJ et al; Adv Alcohol Subst Abuse 7 (3-4): 113-7 (1988)]**PEER REVIEWED** Drug Warnings: Because of the possibility of suicide in depressed patients, close supervision of high risk patients is recommended during initial fluoxetine therapy. To reduce the risk of overdosage, the drug should be prescribed in the smallest quantity consisted with good patient management. Suicidal ideation may persist until substantial remission of the depressive disorder occurs. [McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1992 (Plus Supplements 1992). 1243]**PEER REVIEWED** Risk-benefit should be considered when the following medical problems exist (reasons given where appropriate): Diabetes mellitus (glycemic control may be altered); Hepatic function impairment (metabolism of fluoxetine is delayed; lower doses or less frequent dosing is recommended in patients with liver disease); Renal function impairment (excretion of fluoxetine may be delayed; lower doses or less frequent dosing is recommended in patients with renal disease); History of seizures disorders (seizures may be induced by fluoxetine in patients with a history of seizure disorders). [uSPDI; Drug Information for the Health Care Professional 12 ed V. IA p.1421 (1992)]**PEER REVIEWED** Drugs whose Effect on Nursing Infants is Unknown but may be of Concern: Fluoxetine: None. /from Table 4/ [Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 139 (1994)]**QC REVIEWED** _________________________________________________________________ Join the world’s largest e-mail service with MSN Hotmail. http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 10, 2002 Report Share Posted April 10, 2002 Dear Suzy, Thanks for sharing this. The article came through just fine. This is a very nice compilation of peer reviewed clinical studies. I will forward the information on to the legal firms I am networking with. ML, The Avenging Angel Please sign the petitions at: http://www.petitiononline.com/lilpro http://www.petitiononline.com/oky71.html http://www.petitiononline.com/effexor Please report all adverse drug reactions to: http://www.fda.gov/medwatch/index.html ----Original Message Follows---- From: "suzy nakauchi" Reply-SSRI medications SSRI medications Subject: Another Site Date: Wed, 10 Apr 2002 00:33:28 +0000 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 MSN Photos is the easiest way to share and print your photos: Click Here Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 10, 2002 Report Share Posted April 10, 2002 Dear Suzy, Thanks for sharing this. The article came through just fine. This is a very nice compilation of peer reviewed clinical studies. I will forward the information on to the legal firms I am networking with. ML, The Avenging Angel Please sign the petitions at: http://www.petitiononline.com/lilpro http://www.petitiononline.com/oky71.html http://www.petitiononline.com/effexor Please report all adverse drug reactions to: http://www.fda.gov/medwatch/index.html ----Original Message Follows---- From: "suzy nakauchi" Reply-SSRI medications SSRI medications Subject: Another Site Date: Wed, 10 Apr 2002 00:33:28 +0000 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 MSN Photos is the easiest way to share and print your photos: Click Here Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 10, 2002 Report Share Posted April 10, 2002 Dear Suzy, Thanks for sharing this. The article came through just fine. This is a very nice compilation of peer reviewed clinical studies. I will forward the information on to the legal firms I am networking with. ML, The Avenging Angel Please sign the petitions at: http://www.petitiononline.com/lilpro http://www.petitiononline.com/oky71.html http://www.petitiononline.com/effexor Please report all adverse drug reactions to: http://www.fda.gov/medwatch/index.html ----Original Message Follows---- From: "suzy nakauchi" Reply-SSRI medications SSRI medications Subject: Another Site Date: Wed, 10 Apr 2002 00:33:28 +0000 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 MSN Photos is the easiest way to share and print your photos: Click Here Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 10, 2002 Report Share Posted April 10, 2002 Dear Suzy, Thanks for sharing this. The article came through just fine. This is a very nice compilation of peer reviewed clinical studies. I will forward the information on to the legal firms I am networking with. ML, The Avenging Angel Please sign the petitions at: http://www.petitiononline.com/lilpro http://www.petitiononline.com/oky71.html http://www.petitiononline.com/effexor Please report all adverse drug reactions to: http://www.fda.gov/medwatch/index.html ----Original Message Follows---- From: "suzy nakauchi" Reply-SSRI medications SSRI medications Subject: Another Site Date: Wed, 10 Apr 2002 00:33:28 +0000 Dear Group, Here is another site that I cannot bring to you as it should be viewed. But it is interesting - an obsolete toxnet.nim.nih.gov site last updated 1/14/2002. It also has a link to a new site. Suzy HSDB Toxnet http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~BAAU.aG7g:1 MSN Photos is the easiest way to share and print your photos: Click Here Quote Link to comment Share on other sites More sharing options...
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