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TOPIC: Official FOI FDA Side Effect Reports

Official FOI FDA Side Effect Reports 2 years 3 months ago #12379

  • DrJames
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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:


File Attachment:

File Name: Harvoni(22...port.pdf
File Size:1,070 KB


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
Last Edit: 2 years 3 months ago by DrJames.
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Official FOI FDA Side Effect Reports 2 years 3 months ago #12384

  • LondonGirl
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"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
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Official FOI FDA Side Effect Reports 2 years 3 months ago #12389

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Edema
Treatment naive
F 3/4
Genotype 1 a
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
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Official FOI FDA Side Effect Reports 2 years 3 months ago #12393

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Edema

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
Last Edit: 2 years 3 months ago by DrJames.
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Official FOI FDA Side Effect Reports 2 years 1 month ago #15365

  • Price
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Have you heard of anybody having cardiac problems AFTER they finish treating with Harvoni?

P.
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Official FOI FDA Side Effect Reports 2 years 1 month ago #15372

  • tweakmax
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Maybe before they start treatment, when they find out the price.
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Official FOI FDA Side Effect Reports 2 years 1 month ago #15374

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#roflmao


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
:cheer: :cheer: :cheer:
Last Edit: 2 years 1 month ago by Gaj.
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Official FOI FDA Side Effect Reports 1 year 11 months ago #19254

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Thanks this is very useful information for me..
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Official FOI FDA Side Effect Reports 1 year 11 months ago #19278

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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!!!
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Official FOI FDA Side Effect Reports 1 year 11 months ago #19338

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i have hypertension after treatment

146/96
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Official FOI FDA Side Effect Reports 1 year 11 months ago #19413

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Borderline. After you get your SVR12 and relax check it again
YMMV
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