Petition · Dr. Janet Woodcock: The FDA Must Disclose All Potential Side Effects of Harvoni, Hepatitis C Medication · Change.org

It is estimated that 150 million people world-wide may have the Hepatitis C Virus. On October 10, 2014, the FDA approved the fixed-dose combination capsule of ledipasvir plus sofosbuvir (Harvoni; Gilead Sciences) for the treatment of patients with chronic HCV genotype 1 infection. Ledipasvir plus sofosbuvir is the first combination tablet approved for the treatment of patients with chronic HCV genotype 1 infection, as well as, the first approved regimen that does not require the use of interferon or ribavirin.  The FDA approved the drug under breakthrough therapy designation, which is intended to expedite the development and review of drugs for serious conditions.

Source: Petition · Dr. Janet Woodcock: The FDA Must Disclose All Potential Side Effects of Harvoni, Hepatitis C Medication · Change.org

Harvoni Archives – MedShadow

More than 1,500 additional cases of liver injury have been discovered that are associated with the newest class of hepatitis C drugs. In October, the FDA first identified 24 cases involving safety issues related to the 9 new antiviral drugs for hepatitis C, including Harvoni (ledipasvir-sofosbuvir), Olysio (simeprevir) and Sovaldi (sofosbuvir). While these drugs appeared to lower the hep C virus to undetectable levels in the majority of patients, some of them experienced reactivation of hepatitis B that had serious health consequences, including liver transplant and death. An investigation by the Institute for Safe Medicine Practices of FDA adverse events data identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of liver injury. In a further 761 cases, the adverse event was failure of the antiviral drug against the virus. Posted January 25, 2017. Via ISMP.

Source: Harvoni Archives – MedShadow

Sepsis and septic shock: new guidelines for clinical management – The Clinical Advisor

New guidelines for sepsis and septic shock emphasize frequent patient re-evaluation and patient-specific tailoring of hemodynamic therapy. The guidelines were presented at the 46th Annual Meeting of the Society of Critical Care Medicine (SCCM) and were published online in Critical Care Medicine and Intensive Care Medicine.The guidelines, developed by the SCCM and the European Society of Intensive Care Medicine, serve as an update to the “Surviving Sepsis Campaign Guidelines for Management of Sepsis and Septic Shock: 2012.” The international panel was grouped into 5 sections— hemodynamics, infection, adjunctive therapies, metabolic, and ventilation—and provided 93 statements on early management and resuscitation of patients with sepsis or septic sho

Source: Sepsis and septic shock: new guidelines for clinical management – The Clinical Advisor

briefly before bed

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I HAVE NOT FOUND MYSELF TODAY.

I am wearied and sad in an aimless off-handed way.

I suppose it is one of those ‘IN BETWEEN’ times. It reminds me of Tugun in 2002.

Bring me sunrises and views and birds on my verandah.

Bring me beauty and grace and dignity

Remove me from drunks and drug users.

Bring me to MY place.

Bring me to meetings and water and companions and a passing parade.

Bring me to the Children.

Bring me home.

lynne-camera

________________________________________

And I shall finish with another Sepsis story. So many of us have suffered this way and are suffering.

Bri

This is Part One of my Sepsis Survival Story.
Hello, thanks very much for letting me join this group.
My name is Brian, & I will tell you my story in 2 parts.

I went into Hospital for removal of a gallstone in cystic duct & to have a plastic stent fitted, on Jan 6th 2017. There was a small perforation in my duct by mistake during surgery. This developed into Biliary Sepsis. I didn’t know what this meant at the time. At 39.1 degrees I didn’t know what was really being said to me, I was delirious. Having Severe Sepsis Infection, I was administered intravenously, directly into my veins, Antibiotics, Morphine, paracetamol, fluids & nutritional liquids. If there was anything else like anti-sickness I was not aware. I was told I had raised inflammatory markers, although I could not process a question to ask what it meant as I was drifting to sleep.
Whilst at my worst, I knew I was very ill. I remember getting ready to die. I realised I was not afraid of dying, I was scared of what I would leave behind. Very emotive, but true. I knew I had to be strong to survive and be positive, as I didn’t want to leave my wonderful Wife, family and rabbits behind, and this wonderful life we have, has to continue.
It wasn’t until I left the Hospital, that my Wife Nicky & I started research into Biliary Sepsis & Sepsis. We are shocked & cannot believe we were not offered any information, no aftercare offered, and not told to look for signs of re-occurrence, as this is a known Sepsis habit.
I was sent home with Oral Antibiotics. 5 days after the antibiotics were finished I started feeling ill again.

On the 20th January 2017 I went to Doctors. The Doctor I saw didn’t take any notice in what I was saying, and completely ignored the fact I had surgery 14 days ago. He didn’t want to know about the Biliary Sepsis I had just experienced. Instead he pressed as hard as he could, causing me to grab the inspection bed with both hands & arch my back rigid off the bed, the pain was stupidly intense. When I told him to stop pressing hard & to stop holding his hand down, on the surgical site, as he was hurting me, he just turned away, walked off and said he had finished the examination, I had to go as he was running an hour late and next patient was due. I didn’t even have my full appointment time.
I tried to get up but the waves of pain were too much, I collapsed back on the inspection bed. Dr Potts took no notice & didn’t help me. I used every ounce of strength to sit up on the inspection bed, I managed on the second attempt to sit on the edge, then I was sweating & swaying, feeling light headed. He saw this from his chair but didn’t help, he didn’t care, and he said I had leave. I told him I felt ill and about the worry & anxiety of the early warning signs of re-occurring Sepsis, and the symptoms I was having. He retorted examination was over. I left the room in considerable pain, everything I told the Doctor fell on deaf ears, I found him dismissive, ignorant and uncaring. My Wife was with me & witnessed it all.

The following day my temperature range was 36.8 to 38 degrees. My temp rising around 38 I was having an occasional shiver & a nasty thumping headache over my right eye. I felt stiff, my left shoulder very stiff, and my pain still very high in surgical area from previous day. We both knew these were early warning signs to keep a watchful eye on.

The next day temperature was spiking at 38 degrees & up and down again. I was losing appetite, picking at food, I was feeling extra tired, slightly nauseous in the morning, and I still had the thumping headache over my right eye. My temperature range was 36 to 38. I was drinking lots of fluids, about 4 litres of water, dosed up, but couldn’t shift the headache, which was starting to feel like a migraine.

Sorry for length of this story, it does need to be told. Part 2 will be in the next few days. It will start with a similar heading and will be dated Monday 23rd Jan 2017. Many thanks and good luck to all readers.

Bri Maze King ©
4.2.17.

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SATURDAY

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Another day has passed and one too flash. Pain in my side has become worse and I got Kaybee to get my script out of the chemist. That helped but has meant another day in bed and no meetings. I did have a long conversation on phone with Arkue and I have good food from town via Kaybee.

I also had an hour or so with my girls and now Facetime.That is it for today.