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Official FOI FDA Side Effect Reports 8 years 2 months ago #12379
Greg Jefferys pass along a Freedom of Information Request made to the FDA relating to reported side effects (adverse drug reactions for Harvoni). Here it is in the form delivered: Which is a bit hard to get your head round, but here is what happens if you run it through a bit of software to calculate the frequency of the reports (anything that was reported < 3 times has been ignored. 20.8% (158/759) Headache 18.1% (137/759) Fatigue 5.9% (45/759) Insomnia 5.7% (43/759) Nausea 5.7% (43/759) Diarrhoea 3.7% (28/759) Rash 3.2% (24/759) Anxiety 2.8% (21/759) Vomiting 2.0% (15/759) Nasopharyngitis 2.0% (15/759) Pain 1.8% (14/759) Dyspnoea 1.8% (14/759) Dizziness 1.8% (14/759) Dyspepsia 1.7% (13/759) Abdominal pain 1.7% (13/759) Hypertension 1.7% (13/759) Blood pressure increased 1.7% (13/759) Pruritus 1.4% (11/759) Pyrexia 1.4% (11/759) Depression 1.4% (11/759) Myalgia 1.4% (11/759) Feeling abnormal 1.4% (11/759) Peripheral swelling 1.4% (11/759) Chest pain 1.4% (11/759) Abdominal pain upper 1.3% (10/759) Tinnitus 1.3% (10/759) Influenza 1.3% (10/759) Hepatitis 1.2% (9/759) Cough 1.2% (9/759) Malaise 1.2% (9/759) Arthralgia 1.2% (9/759) Back pain 1.2% (9/759) Weight decreased 1.2% (9/759) Chills 1.2% (9/759) Abdominal discomfort 1.2% (9/759) Confusional state 1.2% (9/759) Pain in extremity 1.2% (9/759) Overdose 1.1% (8/759) Muscle spasms 1.1% (8/759) Constipation 1.1% (8/759) Drug dose omission 1.1% (8/759) Irritability 1.1% (8/759) Influenza like illness 1.1% (8/759) Accidental overdose 1.1% (8/759) Encephalopathy 1.1% (8/759) Somnolence 1.1% (8/759) Rash generalised 0.9% (7/759) Asthenia 0.9% (7/759) Alopecia 0.9% (7/759) Sleep disorder 0.9% (7/759) Drug interaction 0.9% (7/759) Aspartate aminotransferase increased 0.9% (7/759) Decreased appetite 0.8% (6/759) Gastrooesophageal reflux disease 0.8% (6/759) Alanine aminotransferase increased 0.8% (6/759) Death 0.8% (6/759) Convulsion 0.8% (6/759) Sinusitis 0.8% (6/759) Migraine 0.8% (6/759) Ascites 0.8% (6/759) Drug ineffective 0.8% (6/759) Agitation 0.7% (5/759) Flatulence 0.7% (5/759) Pneumonia 0.7% (5/759) Blood bilirubin increased 0.7% (5/759) Dysphagia 0.7% (5/759) Haemoglobin decreased 0.7% (5/759) Rash erythematous 0.7% (5/759) Chest discomfort 0.7% (5/759) Oropharyngeal pain 0.7% (5/759) Abdominal distension 0.7% (5/759) Vision blurred 0.7% (5/759) Blood glucose increased 0.7% (5/759) Visual impairment 0.7% (5/759) Blood creatinine increased 0.5% (4/759) Hyperhidrosis 0.5% (4/759) Abnormal dreams 0.5% (4/759) Cardiac failure congestive 0.5% (4/759) Sepsis 0.5% (4/759) Unknown 0.5% (4/759) Syncope 0.5% (4/759) Nightmare 0.5% (4/759) Lower respiratory tract infection 0.5% (4/759) Lymphadenopathy 0.5% (4/759) Condition aggravated 0.5% (4/759) Stomatitis 0.5% (4/759) Palpitations 0.5% (4/759) Hot flush 0.5% (4/759) Renal impairment 0.5% (4/759) Fluid retention 0.5% (4/759) Pruritus generalised 0.4% (3/759) Renal failure acute 0.4% (3/759) Local swelling 0.4% (3/759) Blood phosphorus decreased 0.4% (3/759) Hypoglycaemia 0.4% (3/759) Retching 0.4% (3/759) Balance disorder 0.4% (3/759) Chromaturia 0.4% (3/759) Memory impairment 0.4% (3/759) Hepatic failure 0.4% (3/759) Product 0.4% (3/759) Bronchitis 0.4% (3/759) Rash pruritic 0.4% (3/759) Blood alkaline phosphatase increased 0.4% (3/759) Dermatitis bullous 0.4% (3/759) Anaemia 0.4% (3/759) Epistaxis 0.4% (3/759) Blood potassium decreased 0.4% (3/759) Epilepsy 0.4% (3/759) Toxicity to various agents 0.4% (3/759) Vertigo 0.4% (3/759) Dehydration 0.4% (3/759) Cerebral haemorrhage 0.4% (3/759) Asterixis 0.4% (3/759) Psychomotor hyperactivity 0.4% (3/759) Blood pressure fluctuation 0.4% (3/759) Urticaria 0.4% (3/759) Feeling cold 0.4% (3/759) Cardiac arrest 0.4% (3/759) Upper respiratory tract infection 0.4% (3/759) Unevaluable event 0.4% (3/759) Disorientation 0.4% (3/759) Speech disorder 0.4% (3/759) Diazepam 0.4% (3/759) Cognitive disorder 0.4% (3/759) Nephrotic syndrome 0.4% (3/759) Hepatic cirrhosis YMMV The following user(s) said Thank You: mgalbrai, Matt-Kenney-google | |
Official FOI FDA Side Effect Reports 8 years 2 months ago #12384
| "Sinusitis" and "Lower resporatory tract infection/ Bronchitis" - Tick tick Plus others...."Feeling cold" ! Had the former for 4 weeks now, in afyone is suffering Saline solution spray gelps, natural sea salt. Interesting for Dan - "Balance disorder" GT1a Dec14 F2/8.7 VL 900000-2.5M Jan16 Hepcivir-L MonkMed/Redemption Baseline: VL 913575 Alt 76 Platelets low Wk2 VL1157 Alt 23 DET Wk 8 VL 32 Alt19 'In the slow lane' June16 Fibro 5.7 F0/1 LIF 1.5 Wk 11 VL<12 Alt 13 Det/Unq Extending tx 12 wks Mylan Sofo/Dac MonkMed Wk 14 VL <12 Det/Unq Wk 16 VL UNDETECTED Wk 22 + 4 Wks Sunprevir FixHepC Wk 24 UNDETECTED Alt 13 Wk 12 post tx SVR12 Wk 26 SVR24 Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC The following user(s) said Thank You: Fara, Matt-Kenney-google |
Official FOI FDA Side Effect Reports 8 years 2 months ago #12389
Edema Treatment naive F 3/4 Genotype 1 a & b V/L 17 MILLION Started Harvoni 11th Dec 2015 for 12 weeks 4 weeks VL UND 6 WEEKS ALT 32, AST 34 EOT 03/03 2016 ! UND ALT 34, AST 26 04.04.2016 SVR 4 26.05.2016 SVR 12 16.08.2016 SVR 24 | |
Official FOI FDA Side Effect Reports 8 years 2 months ago #12393
If you add up all of these different ways of saying it you get to perhaps as much as 4.7% 1.4% (11/759) Peripheral swelling 0.8% (6/759) Ascites 0.7% (5/759) Abdominal distension 0.5% (4/759) Cardiac failure congestive 0.5% (4/759) Fluid retention 0.4% (3/759) Local swelling 0.4% (3/759) Nephrotic syndrome YMMV | |
Official FOI FDA Side Effect Reports 8 years 6 days ago #15374
Thanks tweakmax, that made my evening! (Given the overall patient profile involved, a few cardiac problems are probably par for the course but I suspect there have been no instances directly attributed to the Harvoni as yet or we would likely have heard) G3a since '78 - Dx '12 - F4 (2xHCC) 24wk Tx - PEG/Riba/Dac 2013 relapsed 24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed 16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof SVR7 - 22/06/17 UND SRV12 - 27/07/17 UND SVR24 - 26/10/17 UND | |
Official FOI FDA Side Effect Reports 7 years 9 months ago #19278
Now that is funny! Contracted HCV 1980's Geno Type 1a F3 ( doc says once treated I'll be F2 maybe F1) Meds shipped 6/17/2016 arrived early 7/2016 Viral count - 3,471,080 4 week quantitative bloods: August 17, 2016. I have been diagnosed as <15 (told undetected) 8 week quantitative bloods: September 14th. I have been diagnosed as <15 (told undetected) 11 week PCR RNA Qualitative bloods: September 26th 2016 - Undetected December 19th 2016: Cured! Viral count: zero!!! 2018 viral count: still zero! Cured! The following user(s) said Thank You: fitz | |
Official FOI FDA Side Effect Reports 7 years 9 months ago #19413
Borderline. After you get your SVR12 and relax check it again YMMV | |
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