TOPIC:

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

"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"

Edema

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

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

P.

Maybe before they start treatment, when they find out the price.

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)

Thanks this is very useful information for me..

Now that is funny!

i have hypertension after treatment

146/96

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