It sounds alarmist, it seems mainly to be incorrect dosage given and as a patient being considered for it or taking it I would want to know.
FDA Drug Safety Communication: FDA warns ab... - PBC Foundation
FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease
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Jo_Br
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"Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose"
This is the sentence that makes me nervous. I have been on Urso for 6 months and my enzymes are slowly declining with the exception of a recent spike in my ALK. I think my doctor is about to recommend Ocaliva for me and I am wondering whether it is too soon. It seems like it has been so hugely helpful for so many on this site though. Wishing you good luck with your particular situation Jo_br
Thank you, need the luck. xx It concerns me as Urso not doing its thing for me as you read. For those who are doing well on Urso, it's all good, obviously not symptoms, but the disease is delayed and life can be a normal span. The newer drug that was hailed as being the superstar is now having a blip, it's a tiny blip I imagine, as thousands must be taking it, but Intercept not commenting makes me concerned also.
Do you itch a lot Ottley3 ?
Not really - sometimes I'm itchy but barely a nuisance - to the point if i wonder if its really "the itch" or just a scratchy top i am wearing. My eyes are sometimes dry in the morning. I feel so blessed to be pretty much symptom free except for the twingey pain under my rib cage.
Agree that it's most likely a warning blip on Ocaliva, but maybe Ocaliva is being somewhat over prescribed in certain circumstances, and health care providers should give those like me who are tolerating Urso a few more months before switching. I'd rather have my levels closer to normal as soon as possible but I'm worried by this report. Your situation sounds like a clear case for Ocaliva since Urso clearly not working.
Going to doc Tuesday for fibroscan and will discuss Ocaliva with her and will report back!
Yes, pls let us know what your dr says.
I will not be tried on Ocaliva, I have too much of an itch plague and Ocaliva can cause more. Well after this new curveball of presumed Premature Ductopenic Variant not sure what will happen.
I was about to start Fenofibrates which is not an authorised PBC drug, however, it is a licenced and tested drug for other ailments. It can only be used in a liver unit and monitored regularly.
I will, however, accept Ocaliva if I do have the variant but more likely to be transplanted as disease is pretty fast and nutritionally I am also showing poor results via blood tests, another reason I will be biopsied.
I wish you the best🙏🏻💐
I think it was overdosing very ill patients & those toward end stages. St this time I have no choice. Can't tolerate Urso
From what I've read you also sound like a clear Ocaliva person and I'm glad it's working for you and that you are discussing this all with your doctor!
Have only been on it 3-4 weeks. Labs in November unless I speed it up when I talk to dr. No idea yet if it's working. Tks.
Do you feel any kind of difference? Good luck!
I was only on Urso for week & half. But I will say the slight pain on right side complete went away. Then came the hives. On Oclavia, it seems I may have little bloat off & on & hardly any pain but I feel Urso was the thing to take. Maybe my dr can find a way for me to take it again 🙏🏻
That's my understanding which was confirmed by my medical support people , having been on OCA for 1 month now, numbers coming down and no issues. I trust I'm in good hands.
Thank you. Makes me feel somewhat better😊
However I will discuss with my dr
It clearly says its overdosing, but I would check. There is another for Intercept as well, again incorrect dosing, just makes me a bit concerned as Ocalive I presumed was prescribed by a liver unit.
bloomberg.com/news/articles...
Thank you for this important info. I read both links & have saved to my email so I have proof. He knows I research so he won't be surprised when I call, lol!
Haha, I already have sentences "As you already will have read Jo!"
Jo_Br, I somehow lost Bloomberg link. Can you post it again pls?
Never mind Jo_Br, I've got Bloomberg. Tks!
In another thread regarding this recent warning by Intercept PBCRobert had posted that the foundation team is studying this latest news and hope to have something to add to this important discussion.
Thank you for posting this
For me, the Ocaliva has done wonders. I feel that my university heptologist was very cautious as to how he started me on it & when. The Urso was a great help when I was first diagnosed but I had lost my insurance due to some mix up with paperwork. I went untreated for close to 18 months. Finally got the issue fixed & started the treatment with Urso again. Unfortunately this time the Urso was not working any longer. My ALK Phos was crazy along with the bilirubin & everything else. My GI felt it was time to be referred to Indiana university Medical, Dr Masuoka. He's awesome & I trust him completely!!! He started the paperwork after my second visit, & doing bloods & all of the fun stuff all of us PBC'ers are used to having done. I started the Ocaliva on June 9th with just 5mg a day with the Urso for the first couple months. My numbers started trickling where they were supposed to be. Then he had me start alternating the 5mg with the 10mg for a month until I worked my way to just the 10mg daily with the Urso. So far so good, & my itching hasn't gotten any worse than it was before taking Ocaliva. It isn't every night nor is it to where Im clawing my skin off. Mainly when I wear something tight or where the elastic sticks into my skin. Praying they find something that works for you Jo_Br.
Stay strong❣️
Shannon
Tks Shulsey. I think right now biggest upset of many, is took off Urso after week & a half. 3 weeks waiting for Oclavia. And beennon it a month & now this FDA scare. My mind is in upheaval to say the least.
I just left my heptologist office. I asked of this recent find about the dosage of Ocaliva. He feels that the way he gradually works to the best dosage for the individual patient is the best route. There has been less sickness & itching this way. This is how he has worked With his pbc patients who are on Ocaliva. Those who place their patient right into the max dosage have become very ill because it's too much at one time. Gradually is best. Im resting now because this trip always drains me mentally, physically, & emotionally.
Stay during❣️
Shannon
Well that's what concerns me. According to FDA, dosage should start 5mg 1 x week. I'm on 5mg per day. I'm not taking anymore until I talk to dr. They are supposed to have him call me. Tired of nurses always being the messenger. I'll let you know.
I asked my doctor yesterday while getting my fibroscan and they agreed that a big issue is overdose or as shulsey said, stepping a dose up too quickly. It made me conclude that Ocaliva has risks as do many medicines but it’s one of the best (and the only, right?) options for PBC patients especially those who are advanced in the disease. Appreciate this thread very much, lots of food for thought.
I'm not advanced but since Urso acted ugly, lol. It's 2nd choice.
Ha I know it is but now that I’ve read to the end of the Internet and back and discussed with doctor I feel that properly dosed and monitored ocaliva is an excellent option and we are all lucky that it is out there. Definitely think you should talk to your doc about the dosage just as a precaution.
Thank you. You're right. In the news release from Intercept on Monday, they did say 1 - 5 mg per day is safe. I did call Dr but haven't gotten my call back. Waiting ☹️😊
I would have no qualms in accepting it at a liver unit, I hope it always administered by specialists even in future years. I have been administered the wrong dose of Urso by a gastroenterologist and that has not helped me in my journey at the start (under dosage) and I know that weight is a factor in dosage for it. I also talked to a lady who is in N. Ireland on 900mg and weighs less than me. This is the concern and shows that with PBC we as patients should always be well informed and read up and get support from the PBC Foundation who first queried this.
