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SERIOUS ADVERSE EVENTS FROM INTERFERON TREATMENT
SERIOUS ADVERSE EVENTS
FROM INTERFERON TREATMENT
Featured Passage From the
Center of Biologics Evaluation and Research
Review of Schering Plough's application for PEG-Intron
Selected clinical summaries of serious adverse events are provided below. Deaths are listed first followed by other serious events grouped by organ system. The order in which the organ systems are listed is based on the clinical significance of the adverse events. Psychiatric adverse events were the most frequent and most clinically significant serious adverse events. The clinical manifestations of the most frequent serious adverse events appeared to be similar across treatment groups. The rarer adverse events did not appear to be specific to any treatment group. The clinical descriptions of these events were consistent with those of adverse events previously reported in the literature for interferon alfa and described in the drug label.
Deaths
Suicide: Patient 148 was a 42 year-old woman on PEG-IFN 0.5pg/kg for 25 weeks who died by self-inflicted gunshot wound. Of note is the lack of history of depression. No symptoms or signs of depression were noted by the patient's physicians.
Suicide, murder, paranoid reaction in the post-treatment period: Patient 598 was a 41 year-old man on IFN for 1 year and a history of depression, antisocial behavior, and drug abuse.
Sudden death associated with straining at stool: Patient 406 was a 59 year-old man on IFN for 21 weeks. Myocardial infarction was suspected as cause of death. There were neither history nor symptoms of cardiovascular disease and the study ECG was normal. No postmortem examination was performed.
Psychiatric Adverse Events
The narratives of the psychiatric adverse events indicate that suicidal behavior, namely ideation, attempt, or completed suicide, was commonly (but by no means invariably) associated with a previous history of depression or other psychiatric diagnoses. Depression and other psychiatric disorders occurred both during the interferon-treatment period and in the post-treatment period.
Abuse of illicit drugs or ethanol was reported. Very frequently drug abuse represented a relapse of drug addiction and was often associated with development of depression. Overdoses of illicit drugs were also reported. These events did not appear to be a manifestation of suicidal behavior.
Suicide attempt: Patient 057 was a 49 year-old woman who completed PEG-IFN 1.5 pg/kg for 1 year and attempted suicide (venisection and intake of 24 g of acetaminophen) in the post-treatment period. The patient had a history of depression and anxiety.
Suicide attempt, depression, addiction relapse: Patient 371 was a 33 year-old man who completed treatment with PEG-IFN 1.5 pg/kg. The suicide attempt occurred in the post-treatment period; depression and addiction relapse were also diagnosed at that time. There was a previous history of suicide attempt, depression, and drug abuse.
Suicidal gesture, depression, anxiety, agitation: Patient 053 was a 53-year-old man on PEG-IFN 1 pg/kg for 1 year and a history of depression and drug abuse.
Suicidal/ ideation, depression, aggressive reaction: Patient 139 was a 40 year-old man on IFN-alfa-2b for 36 weeks and a history of depression.
Suicidal ideation, depression aggravated: Patient 824 was a 43 year-old woman on PEG-IFN 0.5 pg/kg for 1 year and a history of depression.
Suicidal ideation, depression, addiction relapse: Patient 96 was a 40 year-old woman on PEG-IFN 1.5 pg/kg for 8 weeks who became depressed with suicidal thoughts and resumed ethanol abuse. Patients had a history of suicidal attempts, depression and alcoholism.
Suicidal ideation, depression, aggressive moods: Patient 411 was a 29 year-old man, on PEG-IFN 1 pg/kg for 5 months. There was no previous history of depression.
Suicidal ideation, depression: Patient 012 was a 39 year-old man. PEG-IFN was discontinued after 42 weeks for severe depression and suicidal thoughts. There was no previous history of depression.
Suicidal ideation, depression: Patient 465 was a 33 year-old man; PEG-IFN 1 .Opg/kg was discontinued after 8 months for severe depression and suicidal thoughts. There was no previous history of depression.
Suicidal ideation, emotional lability, depression: Patient 304 was a 34 year-old woman who was discontinued from PEG-IFN 0.5 yg/kg after about 10 months due to suicidal ideation. There was no previous history of depression.
Suicidal ideation: Patient 288 was a 39 year-old woman on PEG-IFN 1.5pg/kg and no previous history of depression. The event resolved with treatment and IFN was continued.
Depression: Patient 084 was a 37 year-old man on PEG-IFN 0.5 pg/kg for 9 months and a history of depression and drug abuse.
Addiction relapse/overdose: Patient 084 following discontinuation of PEG-IFN due to depression was hospitalized for respiratory failure and required assisted ventilation. A drug screen was positive for amphetamine, benzodiazepine, pentobarbital, marijuana and ethanol.
Depression, drug abuse: Patient 086 was a 34 year-old woman who completed PEG-IFN 1.5 pg/kg treatment. Depression developed and was followed by use of illicit drugs. The patient had a history of depression.
Depression, anxiety, addiction relapse: Patient 024 was a 28 year-old man on PEG-IFN 1.5 pg/kg for 2 months who became anxious, severely depressed an restarted IV drug abuse.
Depression: Patient 089 was a 59 year-old woman on IFN for 2 months who developed severe depression, fatigue and somnolence; previous history of depression.
Depression: Patient 638 was a 43 year-old man who completed one year of treatment with PEG-IFN 0.5 pg/kg. Depression began within 1 month of treatment and waxed and waned in severity. In the post-treatment period the patient was hospitalized for severe depression.
Addiction relapse/overdose, depression, agitation, hypothyroidism: Patient 517 was a 47 year-old man on PEG-IFN 0.5 pg/kg for 37 weeks. He became depressed, agitated, irritable and overdosed on diazepam (#50 10 mg tabs), hydrocodone and dalmane. He developed hypothyroidism requiring treatment. There was a previous history of depression and drug abuse.
Substance abuse, injury accidental: Patient 097 was a 47 year-old man who completed PEG-IFN 0.5 pg/kg treatment. The patient sustained a crush injury with pelvic and rib fractures and bladder injury. During hospitalization for the multiple trauma he developed ethanol withdrawal syndrome.
Addiction relapse: Patient 107 was a 31 year-old man on IFN for 11 months. The patient had history of drug abuse and depression and was hospitalized for detoxification from benzodiazepines.
Addiction relapse, overdose: Patient 306 was a 35 year-old man completed 1 year of treatment with PEG-IFN 0.5 pg/kg. He was hospitalized for an episode of loss of consciousness diagnosed as drug abuse and unintended overdose of lorazepam and valoron. There was a history of drug abuse.
Addiction relapse: Patient 297 a 35 year-old man discontinued IFN treatment after 6 months due to relapse of heroin abuse.
Cardiovascular Adverse Events
Myocardial infarction, septal, age undetermined, cardiomyopathy, severe depression of left ventricular systolic function: Patient 053 was a 53 year old man on PEG-IFN 1 pg/kg for 1 year. He became symptomatic and was diagnosed in the post IFN-treatment period.
Additional evidence of association of ischemic events with IFN consists of one case of myocardial infarction in study C97-058-01 (a PK study), two cases of retinal ischemia in the phase 3 study (see "Ophthalmic" narratives below), and post-marketing reports of ischemic colitis associated with interferon alfa-2b.
Renal Adverse Events
Nephrotic syndrome, interstitial nephritis: Patient 087 was a 42 year old man who completed 1 year's treatment with PEG-IFN 0.5 f_r.g/kg. Dramatic increase in body weight and edema were first noted 1 month after the end of IFN treatment. At 3 months post-treatment heavy proteinuria (6g/24 hrs) was documented with normal urine microscopy, hematology and clinical chemistries. At 4 months post- treatment interstitial nephritis was diagnosed on renal biopsy (focal segmental glomerulosclerosis was included in the differential diagnosis) and corticosteroid treatment was begun for the nephrotic syndrome.
Hematologic Adverse Events
Autoimmune thrombocytopenia: Patient 0002 was a 58 year-old man who received PEG-IFN 1 .O yglkg for 16 weeks. IFN was stopped when the platelet count dropped to 65x10' from 370x10' at baseline. Other hematology parameters including bone marrow aspirate were normal. Anti-platelet glycoprotein Ilb/llla was negative at baseline and elevated during treatment. Increased gingival bleeding was the only clinical manifestation of the cytopenia. Platelet count normalized on corticosteroid treatment. After several months of treatment corticosteroids were tapered off without recurrence of thrombocytopenia.
Autoimmune thrombocytopenia, epistaxis: Patient 157 was a 59 year-old woman who received PEG-IFN 1 .O pg/kg for 3 months. While on study, Parkinson's disease, gastritis, anxiety, and flu-like syndrome were diagnosed and were treated with biperiden, madopar, famotidine, acetaminophen, and a benzodiazepine. IFN was discontinued due to severe thrombocytopenia (27 xl 0'). Anti-platelet glycoprotein la/lla and ANA became weakly positive whereas they were negative at baseline. Bone marrow was not examined. Corticosteroid treatment was deemed unnecessary. Three months after discontinuation of IFN the platelet count was 102 xl 0'.
Ophthalmic Adverse Events
Retinal ischemia, decreased visual Acuity, cotton wool spots: Patient 021 was a 58 year-old man on IFN for 3 months. At 4 weeks of treatment he began to complain of decreased vision at night that progressively grew worse. There was no history of diabetes or cardiovascular disease. Ophthalmologic exam at 3 months showed cotton wool spots in the right eye and microvacular ischemia was documented by angiography. IFN was stopped and ophthalmologic changes were reported to be normal 8 weeks later.
Retinal vein thrombosis, vision disorder: Patient 361 was a 48 year-old woman on IFN for 7 months. Evaluation for scotomas in the right eye revealed a thrombosis of the upper temporal pole of the retinal vein with no involvement of the central vein.
Endocrine Adverse Events
Autoimmune thyroiditis mya/gia,asthenia: Patient 049 was a 30 year-old man, on PEG-INF 1.5 f_rg/kg for 3 months. He developed asthenia, diarrhea, headaches, myalgia, low TSH, elevated T3 and T4 and positive anti-peroxidase antibodies. IFN was discontinued and carbimazole treatment was begun.
lnfections
Because of the bone marrow suppressive effect of interferons alfa, serious infections were reviewed for unusual clinical manifestations or outcomes. The following events were described. Two cases of pneumonias presumed to be bacterial; one case of each of the following: appendicitis; peri-appendiceal abscess with peritonitis; retrouterine abscess in the presence of an IUD; oral abscess following dental extractions; labial abscess associated with controlled diabetes; tonsillitis presumed to be bacterial; erysipelas originating from a wound in the popliteal fossa; aseptic meningitis. The adverse events were not associated with clinically significant decreases in neutrophil counts and patients appeared to recover with treatment. An unusual finding was the presence (in patient 206 on PEG-IFN 0.5 yglkg) of necrotizing epithelioid granulomas in the post-treatment liver biopsy. A diagnosis of mycobacterium infection was considered but was not confirmed.
Neuroloqic Adverse Events
Left-sided facial paralysis associated with neutropenia and thrombocytopenia: Patient 022 was a 62 year-old man on PEG-IFN 1 .O pg/kg for 3 months. Bell's palsy developed while WBC was 0.81 x10' and the platelet count was 81 x10'. Paralysis and cytopenias resolved after discontinuation of IFN. Left-sided facial paralysis: Patient 347 was a 53 year-old woman on PEG-IFN 1 ug/kg for two months and a history of diabetes. Severe Bell's palsy developed, IFN was stopped and corticosteroids begun; 15 weeks later mild facial drooping remained.
Oculomotor nerve paralysis, diplopia: Patient 577 was a 48 year-old man with insulin-controlled diabetes. IFN treatment was discontinued after 5 months because of double vision, and drooping left eyelid. Partial oculomotor nerve palsy was attributed to vasculitis caused by diabetes or IFN.
Hearing loss: Patient 068 was a 36 year-old woman who completed 1 year treatment with PEG-IFN 1.5 yglkg. The patient complained of hearing loss and an audiogram showed a bilateral 30% loss of hearing (30 dB in the 1000 and 2000 Hz frequencies) that remained stable on continued IFN treatment.
Dermatologic Adverse Events
Psoriasis aggravated: Patient 149 was a 37 year-old woman on IFN for 3 weeks and a history of mild psoriasis controlled with topical coal extract. The patient developed a severe flare of psoriasis affecting the extremities and associated with arthralgias and eye irritation. IFN was stopped and cyclosporine and calcipotriene were required to control the psoriasis. Exacerbations of psoriasis recurred in the post-treatment period.
Generalized urticaria: Patient 318 was a 54 year-old woman on PEG-IFN 0.5 pg/kg who developed injection site erythema after the third dose. With the fourth dose the patient developed urticaria that began at the injection site and became generalized. IFN was discontinued and the patient was treated with corticosteroids.
Autoimmune Adverse Events
Systemic lupus erythematosus-like syndrome, Patient 327 was a 71 year-old woman who completed a 1 year course of PEG-IFN 1.5 ug/kg. Six weeks post- treatment the patient developed dyspnea, fever, and thoracic pain. Pericarditis with effusion and pleurisy were diagnosed and diclofenac was administered. GI bleeding occurred, was attributed to diclofenac and was treated with transfusion. A respiratory infection was treated with a cepahalosporin. Serologic testing was positive at high titer for ANA, DS-DNA, TPO, and for thyroid, spleen, thymus, and smooth muscle. No treatment for the autoimmune disorder was considered necessary. To the SLE case should be added the following autoimmune adverse events described above: aggravated psoriasis, thyroiditis, thrombocytopenia, and nephritis. In addition ulcerative colitis (presenting with fever, abdominal pain, and bloody diarrhea) has been associated with interferon alfa by postmarketing adverse event reports."
(33/2-38/8)
FROM INTERFERON TREATMENT
Featured Passage From the
Center of Biologics Evaluation and Research
Review of Schering Plough's application for PEG-Intron
Selected clinical summaries of serious adverse events are provided below. Deaths are listed first followed by other serious events grouped by organ system. The order in which the organ systems are listed is based on the clinical significance of the adverse events. Psychiatric adverse events were the most frequent and most clinically significant serious adverse events. The clinical manifestations of the most frequent serious adverse events appeared to be similar across treatment groups. The rarer adverse events did not appear to be specific to any treatment group. The clinical descriptions of these events were consistent with those of adverse events previously reported in the literature for interferon alfa and described in the drug label.
Deaths
Suicide: Patient 148 was a 42 year-old woman on PEG-IFN 0.5pg/kg for 25 weeks who died by self-inflicted gunshot wound. Of note is the lack of history of depression. No symptoms or signs of depression were noted by the patient's physicians.
Suicide, murder, paranoid reaction in the post-treatment period: Patient 598 was a 41 year-old man on IFN for 1 year and a history of depression, antisocial behavior, and drug abuse.
Sudden death associated with straining at stool: Patient 406 was a 59 year-old man on IFN for 21 weeks. Myocardial infarction was suspected as cause of death. There were neither history nor symptoms of cardiovascular disease and the study ECG was normal. No postmortem examination was performed.
Psychiatric Adverse Events
The narratives of the psychiatric adverse events indicate that suicidal behavior, namely ideation, attempt, or completed suicide, was commonly (but by no means invariably) associated with a previous history of depression or other psychiatric diagnoses. Depression and other psychiatric disorders occurred both during the interferon-treatment period and in the post-treatment period.
Abuse of illicit drugs or ethanol was reported. Very frequently drug abuse represented a relapse of drug addiction and was often associated with development of depression. Overdoses of illicit drugs were also reported. These events did not appear to be a manifestation of suicidal behavior.
Suicide attempt: Patient 057 was a 49 year-old woman who completed PEG-IFN 1.5 pg/kg for 1 year and attempted suicide (venisection and intake of 24 g of acetaminophen) in the post-treatment period. The patient had a history of depression and anxiety.
Suicide attempt, depression, addiction relapse: Patient 371 was a 33 year-old man who completed treatment with PEG-IFN 1.5 pg/kg. The suicide attempt occurred in the post-treatment period; depression and addiction relapse were also diagnosed at that time. There was a previous history of suicide attempt, depression, and drug abuse.
Suicidal gesture, depression, anxiety, agitation: Patient 053 was a 53-year-old man on PEG-IFN 1 pg/kg for 1 year and a history of depression and drug abuse.
Suicidal/ ideation, depression, aggressive reaction: Patient 139 was a 40 year-old man on IFN-alfa-2b for 36 weeks and a history of depression.
Suicidal ideation, depression aggravated: Patient 824 was a 43 year-old woman on PEG-IFN 0.5 pg/kg for 1 year and a history of depression.
Suicidal ideation, depression, addiction relapse: Patient 96 was a 40 year-old woman on PEG-IFN 1.5 pg/kg for 8 weeks who became depressed with suicidal thoughts and resumed ethanol abuse. Patients had a history of suicidal attempts, depression and alcoholism.
Suicidal ideation, depression, aggressive moods: Patient 411 was a 29 year-old man, on PEG-IFN 1 pg/kg for 5 months. There was no previous history of depression.
Suicidal ideation, depression: Patient 012 was a 39 year-old man. PEG-IFN was discontinued after 42 weeks for severe depression and suicidal thoughts. There was no previous history of depression.
Suicidal ideation, depression: Patient 465 was a 33 year-old man; PEG-IFN 1 .Opg/kg was discontinued after 8 months for severe depression and suicidal thoughts. There was no previous history of depression.
Suicidal ideation, emotional lability, depression: Patient 304 was a 34 year-old woman who was discontinued from PEG-IFN 0.5 yg/kg after about 10 months due to suicidal ideation. There was no previous history of depression.
Suicidal ideation: Patient 288 was a 39 year-old woman on PEG-IFN 1.5pg/kg and no previous history of depression. The event resolved with treatment and IFN was continued.
Depression: Patient 084 was a 37 year-old man on PEG-IFN 0.5 pg/kg for 9 months and a history of depression and drug abuse.
Addiction relapse/overdose: Patient 084 following discontinuation of PEG-IFN due to depression was hospitalized for respiratory failure and required assisted ventilation. A drug screen was positive for amphetamine, benzodiazepine, pentobarbital, marijuana and ethanol.
Depression, drug abuse: Patient 086 was a 34 year-old woman who completed PEG-IFN 1.5 pg/kg treatment. Depression developed and was followed by use of illicit drugs. The patient had a history of depression.
Depression, anxiety, addiction relapse: Patient 024 was a 28 year-old man on PEG-IFN 1.5 pg/kg for 2 months who became anxious, severely depressed an restarted IV drug abuse.
Depression: Patient 089 was a 59 year-old woman on IFN for 2 months who developed severe depression, fatigue and somnolence; previous history of depression.
Depression: Patient 638 was a 43 year-old man who completed one year of treatment with PEG-IFN 0.5 pg/kg. Depression began within 1 month of treatment and waxed and waned in severity. In the post-treatment period the patient was hospitalized for severe depression.
Addiction relapse/overdose, depression, agitation, hypothyroidism: Patient 517 was a 47 year-old man on PEG-IFN 0.5 pg/kg for 37 weeks. He became depressed, agitated, irritable and overdosed on diazepam (#50 10 mg tabs), hydrocodone and dalmane. He developed hypothyroidism requiring treatment. There was a previous history of depression and drug abuse.
Substance abuse, injury accidental: Patient 097 was a 47 year-old man who completed PEG-IFN 0.5 pg/kg treatment. The patient sustained a crush injury with pelvic and rib fractures and bladder injury. During hospitalization for the multiple trauma he developed ethanol withdrawal syndrome.
Addiction relapse: Patient 107 was a 31 year-old man on IFN for 11 months. The patient had history of drug abuse and depression and was hospitalized for detoxification from benzodiazepines.
Addiction relapse, overdose: Patient 306 was a 35 year-old man completed 1 year of treatment with PEG-IFN 0.5 pg/kg. He was hospitalized for an episode of loss of consciousness diagnosed as drug abuse and unintended overdose of lorazepam and valoron. There was a history of drug abuse.
Addiction relapse: Patient 297 a 35 year-old man discontinued IFN treatment after 6 months due to relapse of heroin abuse.
Cardiovascular Adverse Events
Myocardial infarction, septal, age undetermined, cardiomyopathy, severe depression of left ventricular systolic function: Patient 053 was a 53 year old man on PEG-IFN 1 pg/kg for 1 year. He became symptomatic and was diagnosed in the post IFN-treatment period.
Additional evidence of association of ischemic events with IFN consists of one case of myocardial infarction in study C97-058-01 (a PK study), two cases of retinal ischemia in the phase 3 study (see "Ophthalmic" narratives below), and post-marketing reports of ischemic colitis associated with interferon alfa-2b.
Renal Adverse Events
Nephrotic syndrome, interstitial nephritis: Patient 087 was a 42 year old man who completed 1 year's treatment with PEG-IFN 0.5 f_r.g/kg. Dramatic increase in body weight and edema were first noted 1 month after the end of IFN treatment. At 3 months post-treatment heavy proteinuria (6g/24 hrs) was documented with normal urine microscopy, hematology and clinical chemistries. At 4 months post- treatment interstitial nephritis was diagnosed on renal biopsy (focal segmental glomerulosclerosis was included in the differential diagnosis) and corticosteroid treatment was begun for the nephrotic syndrome.
Hematologic Adverse Events
Autoimmune thrombocytopenia: Patient 0002 was a 58 year-old man who received PEG-IFN 1 .O yglkg for 16 weeks. IFN was stopped when the platelet count dropped to 65x10' from 370x10' at baseline. Other hematology parameters including bone marrow aspirate were normal. Anti-platelet glycoprotein Ilb/llla was negative at baseline and elevated during treatment. Increased gingival bleeding was the only clinical manifestation of the cytopenia. Platelet count normalized on corticosteroid treatment. After several months of treatment corticosteroids were tapered off without recurrence of thrombocytopenia.
Autoimmune thrombocytopenia, epistaxis: Patient 157 was a 59 year-old woman who received PEG-IFN 1 .O pg/kg for 3 months. While on study, Parkinson's disease, gastritis, anxiety, and flu-like syndrome were diagnosed and were treated with biperiden, madopar, famotidine, acetaminophen, and a benzodiazepine. IFN was discontinued due to severe thrombocytopenia (27 xl 0'). Anti-platelet glycoprotein la/lla and ANA became weakly positive whereas they were negative at baseline. Bone marrow was not examined. Corticosteroid treatment was deemed unnecessary. Three months after discontinuation of IFN the platelet count was 102 xl 0'.
Ophthalmic Adverse Events
Retinal ischemia, decreased visual Acuity, cotton wool spots: Patient 021 was a 58 year-old man on IFN for 3 months. At 4 weeks of treatment he began to complain of decreased vision at night that progressively grew worse. There was no history of diabetes or cardiovascular disease. Ophthalmologic exam at 3 months showed cotton wool spots in the right eye and microvacular ischemia was documented by angiography. IFN was stopped and ophthalmologic changes were reported to be normal 8 weeks later.
Retinal vein thrombosis, vision disorder: Patient 361 was a 48 year-old woman on IFN for 7 months. Evaluation for scotomas in the right eye revealed a thrombosis of the upper temporal pole of the retinal vein with no involvement of the central vein.
Endocrine Adverse Events
Autoimmune thyroiditis mya/gia,asthenia: Patient 049 was a 30 year-old man, on PEG-INF 1.5 f_rg/kg for 3 months. He developed asthenia, diarrhea, headaches, myalgia, low TSH, elevated T3 and T4 and positive anti-peroxidase antibodies. IFN was discontinued and carbimazole treatment was begun.
lnfections
Because of the bone marrow suppressive effect of interferons alfa, serious infections were reviewed for unusual clinical manifestations or outcomes. The following events were described. Two cases of pneumonias presumed to be bacterial; one case of each of the following: appendicitis; peri-appendiceal abscess with peritonitis; retrouterine abscess in the presence of an IUD; oral abscess following dental extractions; labial abscess associated with controlled diabetes; tonsillitis presumed to be bacterial; erysipelas originating from a wound in the popliteal fossa; aseptic meningitis. The adverse events were not associated with clinically significant decreases in neutrophil counts and patients appeared to recover with treatment. An unusual finding was the presence (in patient 206 on PEG-IFN 0.5 yglkg) of necrotizing epithelioid granulomas in the post-treatment liver biopsy. A diagnosis of mycobacterium infection was considered but was not confirmed.
Neuroloqic Adverse Events
Left-sided facial paralysis associated with neutropenia and thrombocytopenia: Patient 022 was a 62 year-old man on PEG-IFN 1 .O pg/kg for 3 months. Bell's palsy developed while WBC was 0.81 x10' and the platelet count was 81 x10'. Paralysis and cytopenias resolved after discontinuation of IFN. Left-sided facial paralysis: Patient 347 was a 53 year-old woman on PEG-IFN 1 ug/kg for two months and a history of diabetes. Severe Bell's palsy developed, IFN was stopped and corticosteroids begun; 15 weeks later mild facial drooping remained.
Oculomotor nerve paralysis, diplopia: Patient 577 was a 48 year-old man with insulin-controlled diabetes. IFN treatment was discontinued after 5 months because of double vision, and drooping left eyelid. Partial oculomotor nerve palsy was attributed to vasculitis caused by diabetes or IFN.
Hearing loss: Patient 068 was a 36 year-old woman who completed 1 year treatment with PEG-IFN 1.5 yglkg. The patient complained of hearing loss and an audiogram showed a bilateral 30% loss of hearing (30 dB in the 1000 and 2000 Hz frequencies) that remained stable on continued IFN treatment.
Dermatologic Adverse Events
Psoriasis aggravated: Patient 149 was a 37 year-old woman on IFN for 3 weeks and a history of mild psoriasis controlled with topical coal extract. The patient developed a severe flare of psoriasis affecting the extremities and associated with arthralgias and eye irritation. IFN was stopped and cyclosporine and calcipotriene were required to control the psoriasis. Exacerbations of psoriasis recurred in the post-treatment period.
Generalized urticaria: Patient 318 was a 54 year-old woman on PEG-IFN 0.5 pg/kg who developed injection site erythema after the third dose. With the fourth dose the patient developed urticaria that began at the injection site and became generalized. IFN was discontinued and the patient was treated with corticosteroids.
Autoimmune Adverse Events
Systemic lupus erythematosus-like syndrome, Patient 327 was a 71 year-old woman who completed a 1 year course of PEG-IFN 1.5 ug/kg. Six weeks post- treatment the patient developed dyspnea, fever, and thoracic pain. Pericarditis with effusion and pleurisy were diagnosed and diclofenac was administered. GI bleeding occurred, was attributed to diclofenac and was treated with transfusion. A respiratory infection was treated with a cepahalosporin. Serologic testing was positive at high titer for ANA, DS-DNA, TPO, and for thyroid, spleen, thymus, and smooth muscle. No treatment for the autoimmune disorder was considered necessary. To the SLE case should be added the following autoimmune adverse events described above: aggravated psoriasis, thyroiditis, thrombocytopenia, and nephritis. In addition ulcerative colitis (presenting with fever, abdominal pain, and bloody diarrhea) has been associated with interferon alfa by postmarketing adverse event reports."
(33/2-38/8)
"It is no measure of health to be well adjusted to a profoundly sick society."
Krishnamurti
Interesting read??? Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America
Given that we are trying to heal and protect our livers, taking AD's or other psych drugs should be something that a person reflects upon for at least as long as they did to decide on whether or not to treat w/ SOC given that: "Psychiatric drugs have repeatedly been shown to worsen mental illness, to say nothing of the risks of liver damage, weight gain, elevated cholesterol and blood sugar, and reduced cognitive function they entail."
Pick your poison.
Krishnamurti
Interesting read??? Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America
Given that we are trying to heal and protect our livers, taking AD's or other psych drugs should be something that a person reflects upon for at least as long as they did to decide on whether or not to treat w/ SOC given that: "Psychiatric drugs have repeatedly been shown to worsen mental illness, to say nothing of the risks of liver damage, weight gain, elevated cholesterol and blood sugar, and reduced cognitive function they entail."
Pick your poison.
there is also much documentation on the serious adverse events associated with life, confusion, suicidal thoughts, diseases of all kinds, homelessness, nervous breakdowns, death, severe selfishness, greed, constant concern with survival which is a mute point., attempts at being happy which only bring temporary high and eventual let down, depression, I know we would all like to live to the end of our life with a high quality of health and wellness, but we never know what is around the corner and we take risks based on choices, science and faith, we hope for the best outcome and deal as best we can with the outcome we get. Its OK to go kicking and screaming into the night, but in the end we have to accept it.
May all beings be free from suffering, May all beings never be separated from the happiness that is free from sorrow, may they rest in equanimity free from attachment and aversion, believing in the equality of all that lives.
May all beings be free from suffering, May all beings never be separated from the happiness that is free from sorrow, may they rest in equanimity free from attachment and aversion, believing in the equality of all that lives.
B-bunch wrote "This is why anti-depressants are recommended before you start treatment"
Sorry but I don't think this broad blanketed statement is at all accurate and is very misleading in itself. Healthy subjects and on an as needed basis they are in fact prescribed mostly well after treatments starts. Of course the operative word being healthy is relative to one's past or current mental health state.
Sorry but I don't think this broad blanketed statement is at all accurate and is very misleading in itself. Healthy subjects and on an as needed basis they are in fact prescribed mostly well after treatments starts. Of course the operative word being healthy is relative to one's past or current mental health state.
James,
Yes I too nearly asked for something like Zoloft near the end of Tx. In fact I never actually did but I worried a lot about what if it did turn into actually harming somebody else or myself. Good luck yourself.
Yes I too nearly asked for something like Zoloft near the end of Tx. In fact I never actually did but I worried a lot about what if it did turn into actually harming somebody else or myself. Good luck yourself.
Steve- we finished tx about the same time 1/27 was my last Riba. I hear what your saying about Riba Rage. I had one incident and got some Zoloft the next day. I never had any urge to hurt myself, I wanted to kick the viruses a$$ and get back to life.
I feel a bit better every day too, although today was a set back. I guess that's to be expected. Wish you the best with your recovery, and SVR.
I feel a bit better every day too, although today was a set back. I guess that's to be expected. Wish you the best with your recovery, and SVR.
In any event I think that there is value within the post involving what I'd prefer to be defined as "sides" rather than doom and gloom yah yah yah buy my supplements ranting. I just completed Tx 3+ weeks ago. While on Tx I have never been so close to "losing" it over basically none events involving complete strangers and even my freakin' television several times. The amount of rage I felt was nearly uncontrollable and scared the you know what out of me especially in view that I have youngsters around. Keep in minds I am also a combat experiened veteran, know how to keep it together and generally not freaked out another driver looking at me the wrong way.
3 days prior to end of Tx I had blurriness (Cotton Wool Spots) in both eyes and the next day a hemmorage in my right retina rendering my better than perfect (20/10) eyesight pretty much useless.
My point is simple: you can read all the warnings on the side of box you want and listen to your Dr.'s warnings until the cows come home but I think our want for a cure obscures us from perhaps heeding these with more conviction. Until you've experienced these sides first hand I believe a little in your face type statistics could maybe help ourselves explore the reality Tx with interferon. Frankly I now worry continuously about "Crap whats next! I do feel better on a daily basis and pray it's ongoing in this fashion.....
3 days prior to end of Tx I had blurriness (Cotton Wool Spots) in both eyes and the next day a hemmorage in my right retina rendering my better than perfect (20/10) eyesight pretty much useless.
My point is simple: you can read all the warnings on the side of box you want and listen to your Dr.'s warnings until the cows come home but I think our want for a cure obscures us from perhaps heeding these with more conviction. Until you've experienced these sides first hand I believe a little in your face type statistics could maybe help ourselves explore the reality Tx with interferon. Frankly I now worry continuously about "Crap whats next! I do feel better on a daily basis and pray it's ongoing in this fashion.....
Not sure about which has a higher percentage BUT a guy in my town was treating at the VA. He was really sick at one point during treatment and went to the VA, they told him to go home and have some chicken soup (literally, would have probably made him feel better) but didn't explain or even suggest to him that he was feeling "normal" for treating.
He went home, used hose from the Koi pond he just built.....exaust straight into driver window and permanent Good Night. I heard this the day after my first shot. His live-in GF didn't really tell anyone he had hep c but wanted to tell me to be careful.
He went home, used hose from the Koi pond he just built.....exaust straight into driver window and permanent Good Night. I heard this the day after my first shot. His live-in GF didn't really tell anyone he had hep c but wanted to tell me to be careful.
I didn't read the post I committed suicide. Question do more people commit suicide who are on INF or not on INF ?
Jerry, if you google this phrase;
---------------------------------------------------------------
"Deaths
Suicide: Patient 148 was a 42 year-old woman on PEG-IFN 0.5pg/kg for 25 weeks who died by self-inflicted gunshot wound.
----------------------------------------------------------------
You will see that it is a posting, a site from Lloyd Wright, a fellow who sells alternative type therapies to people who wish to avoid treating with interferon. I won't get sidetracked into debating the man or his site, but only want to impart to you that the 'evidence" of the post is pretty old, is generated by a vendor and may not be 100% objective.
I'm kind of centrist here; I believe that interferon/ SOC therapy cures many people, is the only solid proven cure there is for TX of HCV, but that it is not 100% safe and that for a percentage of people the "cure" is not without a price.
On the other hand some alternative therapies may be over-pitched and results over promised and in many cases the results are not guaranteed. Some of the evidence may indeed be true, but when factored into the large number of people who have treated successfully one has to ask what the acceptable number of casualties or post TX issues are...... when compared with the number of lives saved with SOC treatment? It would be different if there were other safer therapies available, but so far none really exist. Everybody has their own comfort level with the acceptable number of post TX issues. I accept that it may feel different coming out of a problematic treatment than before going in.
I am waiting myself but as my own sides from HCV begin to mount I myself ask....how much longer is it safe for me to wait? We all risk, whether we decide to wait or decide to treat. there is no one safe path for all people.
best,
Willy
---------------------------------------------------------------
"Deaths
Suicide: Patient 148 was a 42 year-old woman on PEG-IFN 0.5pg/kg for 25 weeks who died by self-inflicted gunshot wound.
----------------------------------------------------------------
You will see that it is a posting, a site from Lloyd Wright, a fellow who sells alternative type therapies to people who wish to avoid treating with interferon. I won't get sidetracked into debating the man or his site, but only want to impart to you that the 'evidence" of the post is pretty old, is generated by a vendor and may not be 100% objective.
I'm kind of centrist here; I believe that interferon/ SOC therapy cures many people, is the only solid proven cure there is for TX of HCV, but that it is not 100% safe and that for a percentage of people the "cure" is not without a price.
On the other hand some alternative therapies may be over-pitched and results over promised and in many cases the results are not guaranteed. Some of the evidence may indeed be true, but when factored into the large number of people who have treated successfully one has to ask what the acceptable number of casualties or post TX issues are...... when compared with the number of lives saved with SOC treatment? It would be different if there were other safer therapies available, but so far none really exist. Everybody has their own comfort level with the acceptable number of post TX issues. I accept that it may feel different coming out of a problematic treatment than before going in.
I am waiting myself but as my own sides from HCV begin to mount I myself ask....how much longer is it safe for me to wait? We all risk, whether we decide to wait or decide to treat. there is no one safe path for all people.
best,
Willy
By now, if you were serious when you posted your statements in 2007, you should have first hand knowledge of Jack's posted Adverse Events. Are you still laughing? Some pretty serious stuff ain't it?!!!
You're very welcome. After all the drivel I thought maybe something pertinent might be appropriate. I think it's likely that you are the only member who read the article. Mike
Thank you for the link. I get so much hep stuff from Clinical Care, that I pushed that one aside when I went through my e-mail Tuesday. I've read about the choline imbalance somewhere else and will make a point to try and read the full article. Thanks again.
Maybe a lot of these so called patients you "documented" are depressed
because
they are sick with HepC. It's not a laugh riot to be sick you know. This is why anti-depressants are recommended before you start treatment. Sounds like you could use a large dose yourself dude. What are you selling?
Everyday people die from heart attacks,organ failures,tumors.
mental health issues, strokes, infections etc.
Interferon/Riba treatment is used to get treat the virus of HepC not straining
while you are on the pot.
Everyone has to die from something. Does Interferon/Riba treatment cause cancer,
drowning, car crashes,heart failure, hit and runs, and drive by shootings too?
because
they are sick with HepC. It's not a laugh riot to be sick you know. This is why anti-depressants are recommended before you start treatment. Sounds like you could use a large dose yourself dude. What are you selling?
Everyday people die from heart attacks,organ failures,tumors.
mental health issues, strokes, infections etc.
Interferon/Riba treatment is used to get treat the virus of HepC not straining
while you are on the pot.
Everyone has to die from something. Does Interferon/Riba treatment cause cancer,
drowning, car crashes,heart failure, hit and runs, and drive by shootings too?
Goofy Dad: Nicely said.
pigeonca: There is nothing mysterious about abbas' "agenda" - he hates interferon, blames it for his health problems, and wants to dissuade other people from using it. Lots of people on this site have stongly held opinions that they try to share with other people, from the use of Dr. Zhang's herbs to the use of high-dose ribavirin. Some of these opinions are harmless others not. It's why MedHelp warns people coming to this site that what they read here are
only
people's
opinions.
A wise man once said, "I may not agree with what you say, but I'll defend to the death your right to say it."
B-bunch: People are not put on anti-depressants before they start tx because they are sick with hepatitis C. They are put on anti-depressants because everyone, including the makers of IFN, know that it causes depression. Jack_12 chose an extremely tasteless, inflammatory way to make this point, but it is still true.
pigeonca: There is nothing mysterious about abbas' "agenda" - he hates interferon, blames it for his health problems, and wants to dissuade other people from using it. Lots of people on this site have stongly held opinions that they try to share with other people, from the use of Dr. Zhang's herbs to the use of high-dose ribavirin. Some of these opinions are harmless others not. It's why MedHelp warns people coming to this site that what they read here are
only
people's
opinions.
A wise man once said, "I may not agree with what you say, but I'll defend to the death your right to say it."
B-bunch: People are not put on anti-depressants before they start tx because they are sick with hepatitis C. They are put on anti-depressants because everyone, including the makers of IFN, know that it causes depression. Jack_12 chose an extremely tasteless, inflammatory way to make this point, but it is still true.
You may have missed it but at Clinical Care you can read the entire article but here is the summary.
SEE: http://clinicaloptions.com/Hepatitis/Treatment%20Updates on depression and HCV - not treatment, the disease.
"Summary: Implications for Clinical Practice
* Prevalence of depressive disorders is increased in HCV-infected individuals when compared with the general population. Reported prevalence rates for depression range from 24% to 70% in HCV-infected patients vs 6% to 10% in the general population.
* Hepatitis C virus
SEE: http://clinicaloptions.com/Hepatitis/Treatment%20Updates on depression and HCV - not treatment, the disease.
"Summary: Implications for Clinical Practice
* Prevalence of depressive disorders is increased in HCV-infected individuals when compared with the general population. Reported prevalence rates for depression range from 24% to 70% in HCV-infected patients vs 6% to 10% in the general population.
* Hepatitis C virus
I don't think we're taking the adverse side effects of tx and shoving them under the rug in any way. One of the MAJOR purposes of this group is to discuss side effects. We're here to help one another, to share useful information and offer support. Abbas, however, has a different agenda - I have no idea what it is, but it doesn't belong here. I think he posts on the net to make sick people feel bad - in other words, he's on a power trip of some sort. We should stop responding to him. I won't say another word.
I don't know what Jack's trip is, but in reading the comments to his post it seems almost universally accepted that we should ignore the risks associated with taking these drugs. Why in Gods name should that infomation be suppressed or discouraged? Discredit the risks if you can, or point out they are often out-weighed by the benefits. But for chris'sakes don't criticize people or call them names for giving the documented risks due consideration just because you wish they weren't real.
It's like the downsides of interferon therapy are some crazy aunt that's to be kept locked in the attic and no one is allowed to dicuss her for fear the neighbors will find out what we're up to.
I'm not anti-interferon - it may very well have saved my life. But still, let's be open to everything it bring with it.
It's like the downsides of interferon therapy are some crazy aunt that's to be kept locked in the attic and no one is allowed to dicuss her for fear the neighbors will find out what we're up to.
I'm not anti-interferon - it may very well have saved my life. But still, let's be open to everything it bring with it.
There's something about a doctor's note that has this on it that makes you worry less about IFN:
Complexity: HIGH. Potentially life-threatening disease.
Anything other than that is just chicken feed.
xo
deb
Complexity: HIGH. Potentially life-threatening disease.
Anything other than that is just chicken feed.
xo
deb
I know you're Abbas or one of his cohorts. LEAVE US ALONE! GO AWAY! WE AREN'T BUYING!
I did the interferon 2b and the worse sx was it worked and 5 yrs later I'm still alive!!
this makes my family and others who were counting on me to be dead by now instead i'm finally incredibly healthy, started a business and building a 'retirement' home on the coast!!
This screws up the family trusts and forces my kids to use their education and my partner to re-evaluate our relationship.
B/ i get to travel and dream and do my yoga--even w/o the meditation @ times.
So living well and llng is the best or worst sx of tx w/interferon.
this makes my family and others who were counting on me to be dead by now instead i'm finally incredibly healthy, started a business and building a 'retirement' home on the coast!!
This screws up the family trusts and forces my kids to use their education and my partner to re-evaluate our relationship.
B/ i get to travel and dream and do my yoga--even w/o the meditation @ times.
So living well and llng is the best or worst sx of tx w/interferon.
It's so nice to hear that you're doing well. My, you have come a very long way and I am pleased to have been here to see you overcome this horrible disease. I wish you the very best. Mike
Death from liver cancer and end stage liver disease make that look like a picnic in the park.
Thanks though. I'd rather worry about being bitten to death by red ants rather than be too much of a CHICKEN to do anything about a potentially life threatening disease.
My momma didn't raise no scardy cat baby pansy girl - maybe she could'a give you some nuts.
Thanks though. I'd rather worry about being bitten to death by red ants rather than be too much of a CHICKEN to do anything about a potentially life threatening disease.
My momma didn't raise no scardy cat baby pansy girl - maybe she could'a give you some nuts.
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