Home › Forums › Main Forum › Experts Corner › Official FOI FDA Side Effect Reports
- This topic has 10 replies, 8 voices, and was last updated 8 years, 5 months ago by Dr James.
-
AuthorPosts
-
5 March 2016 at 10:32 am #13352
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:
Harvoni(2275)-DetailedReport.pdf
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
5 March 2016 at 11:18 am #13356“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 HepC5 March 2016 at 12:33 pm #13361Edema
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 245 March 2016 at 1:33 pm #13366Edema
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
30 April 2016 at 10:10 am #16423Have you heard of anybody having cardiac problems AFTER they finish treating with Harvoni?
P.
30 April 2016 at 1:06 pm #16430Maybe before they start treatment, when they find out the price.
30 April 2016 at 1:22 pm #16432Thanks 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
7 July 2016 at 4:29 pm #20663Thanks this is very useful information for me..
8 July 2016 at 6:45 am #20690Now 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 7/2016Viral 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!9 July 2016 at 7:06 pm #20753i have hypertension after treatment
146/96
11 July 2016 at 9:29 pm #20832 -
AuthorPosts
- You must be logged in to reply to this topic.