Database of Adverse Event Notifications - medicines

Transcription

1 Database of Adverse Event Notifications - medicines You searched for the following 2 medicines between 01/01/ /10/2017: Invokana (Canagliflozin) Not specified (Canagliflozin) Commonwealth of Australia This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or ed to <tga.copyright@tga.gov.au>.

2 Important information The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises people taking prescription medicines not to change their medication regime without prior consultation with a health professional. About the Database of Adverse Event Notifications (DAEN) - medicines relation to medicines including vaccines used in Australia. The DAEN - medicines contains information from reports of adverse events that the TGA has received in The DAEN - medicines does not contain all known safety information about a particular medicine. Please do not make an assessment about the safety of a medicine based on the information in the DAEN - medicines. The TGA medicine safety monitoring program More information about the DAEN - medicines and the TGA medicines safety monitoring program is available at: About the DAEN - medicines < Medicines safety < You are encouraged to report an adverse event of being related to a medicine used in Australia. Reports of adverse events in relation to medicines and vaccines can be reported using the 'blue card' reporting form, by phone and online < Other useful sources of information on Australian medicines More information about a medicine is available from the Product Information (PI) < and Consumer Medicine Information (CMI) < leaflet or the labelling of the medicine. Australian Public Assessment Report for Prescription Medicines (AusPARs) < for some prescription medicines, are also available from the TGA website. < Your health professional can also provide help and assistance on how to use medicines. Information on medicines used in Australia is available from NPS MedicineWise < About the release of this information While reasonable care is taken to ensure that the information is an accurate record of the adverse events reported to the TGA, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose. To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information. Copyright restrictions apply to the DAEN - medicines < Report generated 6/02/2018 9:07:35 AM Page 2 of 5

3 Results reports (): 27 (Multiple adverse events have been reported for some patients) with medicine: 26 (The TGA thinks there is a possibility that the medicine caused the adverse event) outcome: 1 (These reports of death may or may not have been a result of taking a medicine) MedDRA system organ class i MedDRA reaction term ii iii with Metabolism and nutrition Dehydration Metabolism and nutrition Diabetic ketoacidosis Investigations Glomerular filtration rate decreased Cardiac Myocardial infarction Metabolism and nutrition Ketoacidosis Renal and urinary Renal failure Investigations Weight decreased Cardiac Tachycardia General and Thirst Infections and infestations Urinary tract infection Ear and labyrinth Vertigo Infections and infestations Vulvovaginal candidiasis Injury, poisoning and procedural complications Off label use Nervous system Cognitive disorder Investigations Urine output increased Injury, poisoning and procedural complications Incorrect dose administered Renal and urinary Acute kidney injury Infections and infestations Candida infection Injury, poisoning and procedural complications Wrong technique in product usage process tissue Rhabdomyolysis Nervous system Somnolence Nervous system Syncope Nervous system Lethargy Investigations Liver function test abnormal Nervous system Loss of consciousness Report generated 6/02/2018 9:07:35 AM Page 3 of 5

4 MedDRA system organ class i MedDRA reaction term ii iii General and with Malaise Gastrointestinal Nausea Renal and urinary Nephrogenic diabetes insipidus Renal and urinary Nocturia Infections and infestations Oral candidiasis Renal and urinary Pollakiuria Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rash pruritic Renal cancer Nervous system Headache Hyperhidrosis Nervous system Hypoglycaemic coma Nervous system Disturbance in attention General and Respiratory, thoracic and mediastinal Drug ineffective Dyspnoea Cardiac Angina unstable tissue Reproductive system and breast Back pain Balanoposthitis Investigations Blood glucose increased Investigations Blood potassium decreased Investigations Blood pressure increased Cardiac Cardiac arrest General and Concomitant disease aggravated Footnotes i A description of what, in general terms, was affected by the adverse event, as described by the Medical Dictionary for Regulatory Activities MedDRA (for example 'cardiac ') ii A description of the adverse event as defined by MedDRA; these adverse events are grouped by system organ class. You can use the MedlinePlus medical dictionary < to look up terms. iii The number of for which each type of adverse event was reported iv Results show a medicine is the only medicine to be related to the adverse event Report generated 6/02/2018 9:07:35 AM Page 4 of 5

5 v These reports of death may or may not have been the result of taking a medicine Report generated 6/02/2018 9:07:35 AM Page 5 of 5

6 Database of Adverse Event Notifications - medicines You searched for the following 3 medicines between 01/01/ /10/2017: Dapaglifozin (Dapagliflozin) Forxiga (Dapagliflozin) Xigduo XR (Dapagliflozin-Metformin) Commonwealth of Australia This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or ed to <tga.copyright@tga.gov.au>.

7 Important information The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises people taking prescription medicines not to change their medication regime without prior consultation with a health professional. About the Database of Adverse Event Notifications (DAEN) - medicines relation to medicines including vaccines used in Australia. The DAEN - medicines contains information from reports of adverse events that the TGA has received in The DAEN - medicines does not contain all known safety information about a particular medicine. Please do not make an assessment about the safety of a medicine based on the information in the DAEN - medicines. The TGA medicine safety monitoring program More information about the DAEN - medicines and the TGA medicines safety monitoring program is available at: About the DAEN - medicines < Medicines safety < You are encouraged to report an adverse event of being related to a medicine used in Australia. Reports of adverse events in relation to medicines and vaccines can be reported using the 'blue card' reporting form, by phone and online < Other useful sources of information on Australian medicines More information about a medicine is available from the Product Information (PI) < and Consumer Medicine Information (CMI) < leaflet or the labelling of the medicine. Australian Public Assessment Report for Prescription Medicines (AusPARs) < for some prescription medicines, are also available from the TGA website. < Your health professional can also provide help and assistance on how to use medicines. Information on medicines used in Australia is available from NPS MedicineWise < About the release of this information While reasonable care is taken to ensure that the information is an accurate record of the adverse events reported to the TGA, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose. To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information. Copyright restrictions apply to the DAEN - medicines < Report generated 6/02/2018 9:06:35 AM Page 2 of 8

8 Results reports (): 209 (Multiple adverse events have been reported for some patients) with medicine: 178 (The TGA thinks there is a possibility that the medicine caused the adverse event) outcome: 1 (These reports of death may or may not have been a result of taking a medicine) MedDRA system organ class i MedDRA reaction term ii iii with Metabolism and nutrition Diabetic ketoacidosis Metabolism and nutrition Ketoacidosis Infections and infestations Urinary tract infection Gastrointestinal Nausea Investigations Glomerular filtration rate decreased Injury, poisoning and procedural complications Off label use Renal and urinary Renal impairment Renal and urinary Acute kidney injury Rash Gastrointestinal Vomiting Metabolism and nutrition Dehydration Nervous system Dizziness Infections and infestations Pyelonephritis Infections and infestations Candida infection Infections and infestations Urosepsis Investigations Weight decreased Nervous system Headache Renal and urinary Haematuria Metabolism and nutrition Hyperglycaemia General and Fatigue Infections and infestations Necrotising fasciitis General and tissue Neoplasms benign, malignant and unspecified (incl cysts and polyps) Drug ineffective Back pain Bladder cancer Report generated 6/02/2018 9:06:35 AM Page 3 of 8

9 MedDRA system organ class i MedDRA reaction term ii iii with Infections and infestations Vulvovaginal candidiasis tissue Myalgia Renal and urinary Pollakiuria Renal and urinary Renal failure Injury, poisoning and procedural complications Product use issue Investigations Liver function test increased Rash pruritic Infections and infestations Sepsis Nervous system Syncope Injury, poisoning and procedural complications General and Fall Malaise Gastrointestinal Pancreatitis Metabolism and nutrition Urticaria Hyperglycaemic hyperosmolar nonketotic syndrome Investigations Blood ketone body increased Reproductive system and breast Balanoposthitis Gastrointestinal Abdominal pain Metabolism and nutrition Acidosis Alopecia Investigations Anion gap increased Investigations Blood glucose increased Metabolism and nutrition Ketosis Metabolism and nutrition Hypoglycaemia Metabolism and nutrition Hyponatraemia Vascular Hypotension Infections and infestations Infection Infections and infestations Influenza Metabolism and nutrition Lactic acidosis Hepatobiliary Liver disorder Investigations Liver function test abnormal Report generated 6/02/2018 9:06:35 AM Page 4 of 8

10 MedDRA system organ class i MedDRA reaction term ii iii Blood and lymphatic system Neoplasms benign, malignant and unspecified (incl cysts and polyps) with Lymphopenia Neoplasm malignant Renal and urinary Nephropathy General and Oedema peripheral Infections and infestations Oral candidiasis Gastrointestinal Oral pain Infections and infestations Orchitis Metabolism and nutrition Fluid overload Hepatobiliary Gallbladder disorder Infections and infestations Gastroenteritis Investigations Glycosylated haemoglobin increased Investigations Haematocrit increased Gastrointestinal Diarrhoea Metabolism and nutrition Hyperkalaemia Hyperkeratosis Investigations Haemoglobin increased Investigations Heart rate increased Hepatobiliary Hepatic function abnormal Metabolism and nutrition Hypercholesterolaemia Investigations Blood potassium increased Investigations Blood pressure decreased Cardiac Cardiac failure Nervous system Cerebrovascular accident General and General and Investigations Chest discomfort Condition aggravated Creatinine renal clearance decreased Cardiac Aortic valve incompetence tissue Arthralgia Metabolism and nutrition Acidosis hyperchloraemic Nervous system Ageusia Report generated 6/02/2018 9:06:35 AM Page 5 of 8

11 MedDRA system organ class i MedDRA reaction term ii iii Neoplasms benign, malignant and unspecified (incl cysts and polyps) with Bile duct cancer Blister Psychiatric Delirium Psychiatric Depression Metabolism and nutrition Diabetes mellitus inadequate control Gastrointestinal Dry mouth Dry skin Nervous system Dysgeusia Respiratory, thoracic and mediastinal Respiratory, thoracic and mediastinal Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysphonia Dyspnoea Eczema Lung neoplasm malignant Investigations Urine output increased Cardiac Cardiac disorder Reproductive system and breast Genital haemorrhage Metabolism and nutrition Decreased appetite Neoplasms benign, malignant and unspecified (incl cysts and polyps) General and General and Renal neoplasm Ill-defined disorder Disease progression Psychiatric Psychotic disorder Infections and infestations Cellulitis of male external genital organ Hepatobiliary Liver injury Reproductive system and breast Reproductive system and breast Vulvovaginal burning sensation Skin plaque Vulvovaginal pain Investigations Weight increased Report generated 6/02/2018 9:06:35 AM Page 6 of 8

12 MedDRA system organ class i MedDRA reaction term ii iii tissue with Spinal pain Nervous system Visual field defect Infections and infestations Urinary tract infection bacterial Reproductive system and breast Vulvovaginal pruritus Gastrointestinal Gastric disorder Vascular Aortic dilatation tissue Lupus-like syndrome Infections and infestations Candiduria Vascular Deep vein thrombosis Infections and infestations Pulmonary sepsis Gastrointestinal Oesophageal rupture Infections and infestations Escherichia urinary tract infection Reproductive system and breast Blood and lymphatic system Penile blister Pancytopenia Investigations Platelet count decreased Infections and infestations Pneumonia Metabolism and nutrition Metabolic acidosis Cardiac Mitral valve incompetence tissue General and Muscle atrophy Pyrexia Metabolism and nutrition Polydipsia Renal and urinary Polyuria Renal and urinary Proteinuria Respiratory, thoracic and mediastinal Pulmonary embolism Cardiac Tachycardia General and Thirst Infections and infestations Tinea cruris Cardiac Tricuspid valve incompetence Renal and urinary Urinary incontinence Renal and urinary Urinary retention Report generated 6/02/2018 9:06:35 AM Page 7 of 8

13 MedDRA system organ class i MedDRA reaction term ii iii with Nervous system Somnolence Stevens-Johnson syndrome Rash generalised Rash maculo-papular Infections and infestations Rash pustular Infections and infestations Renal abscess Renal and urinary Renal disorder Eye Retinal disorder Eye Retinopathy tissue Rhabdomyolysis Nervous system Seizure Renal and urinary Renal tubular injury Reproductive system and breast Injury, poisoning and procedural complications General and Penile burning sensation Intentional product misuse Multiple organ dysfunction syndrome Renal and urinary End stage renal disease Gastrointestinal Anal incontinence Footnotes i A description of what, in general terms, was affected by the adverse event, as described by the Medical Dictionary for Regulatory Activities MedDRA (for example 'cardiac ') ii A description of the adverse event as defined by MedDRA; these adverse events are grouped by system organ class. You can use the MedlinePlus medical dictionary < to look up terms. iii The number of for which each type of adverse event was reported iv Results show a medicine is the only medicine to be related to the adverse event v These reports of death may or may not have been the result of taking a medicine Report generated 6/02/2018 9:06:35 AM Page 8 of 8

14 Database of Adverse Event Notifications - medicines You searched for the following 6 medicines between 01/01/ /10/2017: JARDIAMET 12.5 mg / 500 mg (Empagliflozin-Metformin Hydrochloride) Jardiamet 12.5 mg/1000 mg (Empagliflozin-Metformin Hydrochloride) Jardiamet NOS (Empagliflozin-Metformin Hydrochloride) Jardiance (Empagliflozin) Not specified (Empagliflozin) Not specified (Empagliflozin-Metformin Hydrochloride) Commonwealth of Australia This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or ed to <tga.copyright@tga.gov.au>.

15 Important information The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises people taking prescription medicines not to change their medication regime without prior consultation with a health professional. About the Database of Adverse Event Notifications (DAEN) - medicines relation to medicines including vaccines used in Australia. The DAEN - medicines contains information from reports of adverse events that the TGA has received in The DAEN - medicines does not contain all known safety information about a particular medicine. Please do not make an assessment about the safety of a medicine based on the information in the DAEN - medicines. The TGA medicine safety monitoring program More information about the DAEN - medicines and the TGA medicines safety monitoring program is available at: About the DAEN - medicines < Medicines safety < You are encouraged to report an adverse event of being related to a medicine used in Australia. Reports of adverse events in relation to medicines and vaccines can be reported using the 'blue card' reporting form, by phone and online < Other useful sources of information on Australian medicines More information about a medicine is available from the Product Information (PI) < and Consumer Medicine Information (CMI) < leaflet or the labelling of the medicine. Australian Public Assessment Report for Prescription Medicines (AusPARs) < for some prescription medicines, are also available from the TGA website. < Your health professional can also provide help and assistance on how to use medicines. Information on medicines used in Australia is available from NPS MedicineWise < About the release of this information While reasonable care is taken to ensure that the information is an accurate record of the adverse events reported to the TGA, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose. To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information. Copyright restrictions apply to the DAEN - medicines < Report generated 6/02/2018 9:05:34 AM Page 2 of 7

16 Results reports (): 130 (Multiple adverse events have been reported for some patients) with medicine: 117 (The TGA thinks there is a possibility that the medicine caused the adverse event) outcome: 0 (These reports of death may or may not have been a result of taking a medicine) MedDRA system organ class i MedDRA reaction term ii iii with Metabolism and nutrition Diabetic ketoacidosis Gastrointestinal Vomiting Metabolism and nutrition Ketoacidosis Gastrointestinal Nausea General and Malaise Renal and urinary Acute kidney injury Infections and infestations Urinary tract infection Injury, poisoning and procedural complications Off label use Metabolism and nutrition Polydipsia Vascular Hypotension Gastrointestinal Diarrhoea Gastrointestinal Abdominal pain Infections and infestations Cellulitis General and Pyrexia Investigations Weight decreased Investigations Blood ketone body increased Erythema Investigations Glomerular filtration rate decreased Metabolism and nutrition Hyperglycaemia Gastrointestinal Pancreatitis Gastrointestinal Pancreatitis acute Renal and urinary Nocturia Cardiac Myocardial infarction Metabolism and nutrition Metabolic acidosis Nervous system Migraine Report generated 6/02/2018 9:05:34 AM Page 3 of 7

17 MedDRA system organ class i MedDRA reaction term ii iii tissue with Muscle spasms Metabolism and nutrition Hyperkalaemia Metabolism and nutrition Hypoglycaemia Metabolism and nutrition Hyponatraemia Metabolism and nutrition Lactic acidosis Nervous system Lethargy Vascular Circulatory collapse Nervous system Dizziness Gastrointestinal Dry mouth Respiratory, thoracic and mediastinal tissue Dyspnoea Back pain Psychiatric Confusional state Gastrointestinal Constipation Respiratory, thoracic and mediastinal Cough Metabolism and nutrition Dehydration Investigations Blood glucose increased Renal and urinary Polyuria Infections and infestations Sepsis Nervous system Somnolence Nervous system Syncope Cardiac Tachycardia Renal and urinary Renal impairment Infections and infestations Respiratory tract infection Metabolism and nutrition Reproductive system and breast Hyperglycaemic hyperosmolar nonketotic syndrome Penile oedema Infections and infestations Oral herpes Renal and urinary Lower urinary tract symptoms Infections and infestations Candida infection General and Thirst Nervous system Tremor Renal and urinary Urinary incontinence Report generated 6/02/2018 9:05:34 AM Page 4 of 7

18 MedDRA system organ class i MedDRA reaction term ii iii with Renal and urinary Urinary retention Nervous system Post herpetic neuralgia Reproductive system and breast Prostatitis Pruritus Infections and infestations Pyelonephritis acute Infections and infestations Pyuria Respiratory, thoracic and mediastinal Rash Respiratory disorder Eye Retinal vein occlusion Eye Retinopathy Investigations Blood ketone body present Nervous system Restless legs syndrome Metabolism and nutrition Decreased appetite General and Adverse drug reaction Surgical and medical procedures Gastrectomy Gastrointestinal Gastric disorder Ear and labyrinth Vertigo Eye Vision blurred Renal and urinary Tubulointerstitial nephritis General and Concomitant disease progression Nervous system Brain oedema Renal and urinary Leukocyturia Infections and infestations Staphylococcal bacteraemia Surgical and medical procedures Diabetes mellitus management Investigations Blood luteinising hormone abnormal Investigations Blood ph abnormal Investigations Blood pressure decreased Investigations Blood pressure systolic decreased Cardiac Cardiac arrest Investigations Cardiac output decreased Gastrointestinal Abdominal pain upper Infections and infestations Abscess Report generated 6/02/2018 9:05:34 AM Page 5 of 7

19 MedDRA system organ class i MedDRA reaction term ii iii with Metabolism and nutrition Acidosis Nervous system Altered state of consciousness Psychiatric Anxiety Surgical and medical procedures Aortic valve replacement Psychiatric Depression Nervous system Diabetic coma Nervous system Diabetic hyperosmolar coma Investigations Blood creatinine increased Investigations Blood glucose decreased Nervous system Cerebrovascular accident General and Chest pain Renal and urinary Dysuria Investigations Electrocardiogram QT prolonged Eye Dry eye General and Condition aggravated Metabolism and nutrition Gout Nervous system Headache Injury, poisoning and procedural complications General and Fall Fatigue Investigations Fibrin D dimer increased Metabolism and nutrition Fluid retention Vascular Flushing Investigations Glomerular filtration rate abnormal Investigations Liver function test abnormal Infections and infestations Lower respiratory tract infection Nervous system Memory impairment Surgical and medical procedures Knee arthroplasty Hyperhidrosis Metabolism and nutrition Hypovolaemia Nervous system Incoherent Infections and infestations Influenza Investigations Insulin C-peptide decreased Report generated 6/02/2018 9:05:34 AM Page 6 of 7

20 MedDRA system organ class i MedDRA reaction term ii iii tissue with Myalgia Gastrointestinal Mouth ulceration Gastrointestinal Abdominal discomfort Neoplasms benign, malignant and unspecified (incl cysts and polyps) General and Injury, poisoning and procedural complications Neoplasm Oedema peripheral Overdose Cardiac Palpitations Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma Infections and infestations Parotitis Vascular Peripheral ischaemia Congenital, familial and genetic Phimosis Infections and infestations Pneumonia Renal and urinary Pollakiuria Footnotes i A description of what, in general terms, was affected by the adverse event, as described by the Medical Dictionary for Regulatory Activities MedDRA (for example 'cardiac ') ii A description of the adverse event as defined by MedDRA; these adverse events are grouped by system organ class. You can use the MedlinePlus medical dictionary < to look up terms. iii The number of for which each type of adverse event was reported iv Results show a medicine is the only medicine to be related to the adverse event v These reports of death may or may not have been the result of taking a medicine Report generated 6/02/2018 9:05:34 AM Page 7 of 7