Intercept Dives On Warning Of Drug-Related Injuries, Deaths

[Betonarme]

investors.com/news/technolo...

Additionally, Intercept's Letter to Health Care Providers can be found here:

ocalivahcp.com/_assets/_pdf...

but not here:

ocaliva.com/

If you just browse to ocalivahcp.com, a small window pops up containing the Letter.

[gwillistexas]

OMG!!! Thanks. I'll talk to my GI.

[gwillistexas]

I cannot thank you enough. Surely my GI can try Urso again & prescribe antihistamine for any hives. Oh dear, talk about scared & nowhere to run🏃🏼‍♀️

[gwillistexas]

I have fibroscan tomorrow morning. Was told a Dr will be there also. I am not taking Oclavia today & will address it at my fibroscan if a dr is in fact present.

[Sachin1234]

Did you find any death mention on website? Read before get any panicking!!

I didn't not find any harm then better while reading unless I didn't understand!!

Please read or counsel before stressing!

All I find is very interesting and positive patients trail about oclivia!

[SheepJane in reply to Sachin1234]

The letter that pops up DOES specifically mention death and liver damage. The warning is about dosage levels of OCALIVA. I think anyone who is prescribed that should download the letter and contact whoever prescribed it to them asap. It's a very serious warning.

[Sachin1234]

That letter is about how to prescribe oclivia!

[Shulsey]

Ocaliva is recommended with very positive outcomes in the States. If it was the cause of injuries & death I don't believe it would have been passed & legalized. It is the only thing that has helped me so I will not let one article make me run scared. Anyway, you cannot believe everything that is printed. I refuse to even read this. And for all of you who are new to all of this fun stuff😉, please speak with your specialists. Again, there has been nothing but praise from my university heptologist in regards to Ocaliva🙂 & I refuse to believe he would have me taking anything that would be harmful for me❤️

Stay strong❣️

Shannon

[gwillistexas in reply to Shulsey]

Very well said. When the hospital called to confirm fibroscan in the morning, she said there will be a dr there. Whether it will be my dr, I don't know. But I will ask about this. Yes it scared me. I do know their trials are still ongoing, as to whether it prolongs life & if it keeps you off transplant list. If you were pleased with your results then that's a big plus. 😊

[claygi in reply to Shulsey]

While I agree with you about being vigilant in checking with your own doctor, I think you're not clearly understanding. You must read the information.

What is posted is a letter from the Chief Medical Officer of Intercept himself, he has listed the warnings about toxicity and death due to incorrect dosing of the drug Ocaliva. The actual drug manufacturer is self reporting morbidity and death of patients in clinical trials of their own product. This is a very serious warning that should NOT be ignored, especially for those with moderate to advanced disease.

Please click all the links and read the information reported by the doctor, as in fact this is the most serious kind of warning when coming from the manufacturer themselves.

[Q8Cooper in reply to claygi]

Some one here stated in addition to seven deaths of latent stage pbc patients prescribed inappropriate dose for their stage of illness - There were five deaths on Ocaliva of patients in early stages on Ocaliva. I haven't been able to find any information to validate this. Please tell me if anyone has any information regarding this.

Kathy - Patient on Ocaliva

[gwillistexas in reply to Q8Cooper]

I also take Ocalvia. Yes, they did say some with mild fibrosis & were being dosed properly. They also stated your dr should monitor closely for few months. My GI is following that recommendation.

[Q8Cooper in reply to gwillistexas]

Thanks for your response. My doctor has been watching me closely as well

[Sachin1234]

I would recommend to read ocliviahcp.com tho

[gwillistexas in reply to Sachin1234]

Oh I have. When I was first put on it, everything i resesrched, I sent to my email & saved in archive. Full of info🤗 my GI says he likes a well informed patient. If he only knew, lol!🙃

[LisaC22]

I'm not sure if I'm over simplifying this but isn't this just a warning against overdosing on this drug? That overdosing is dangerous? As it is with almost all drugs??

[Sachin1234 in reply to LisaC22]

Yes! if uses as company criteria, oclivia works better for patient who are resistant or less effective to urso!

Every drugs has side effects even aspirin and penicillin "the wonder drugs," kills!!

[claygi]

I am posting this in the main thread as it is critically important to read.

What is posted in the links are several things, the second link is to a letter from the Chief Medical Officer of Intercept himself, he has listed the warnings about toxicity and death due to incorrect dosing of the drug Ocaliva. The actual drug manufacturer is self reporting morbidity and death of patients in clinical trials of their own product. This is a very serious warning that should NOT be ignored.

Please click all the links and read the information reported, as in fact this is the most serious kind of warning when coming from the manufacturer themselves.

[PBCRobert Partner]

We are still researching this and shall make a statement when we have all the relevant facts.

From what we can fathom, difficulties can arise when clinicians do not keep to the guidance for dosing OCA. There is clear guidance as to how much OCA should be prescribed and to whom. e.g. patients with a Child-Pugh score of B or C would be prerscribed less than patients with closer to normal liver health.

We are looking into this in more detail and shall announce what we can as soon as we can.

Yours,

Robert.

[AB12 in reply to PBCRobert]

Thank you Robert. As part of your review there is also a statement that states "In addition serious liver adverse events have been reported in patients initiating therapy without cirrhosis or with mild liver impairment" this would indicate that it is broader than the dosing discussion above. I have been on the trial for 9 months in the uk and fully aware of the dosage approach linked to Child Pugh score but as above was surprised by this additional statement from Intercept.

[PBCRobert Partner in reply to AB12]

Thank you.

We are still checking all of this out. I have a teleconference in an hour where I shall hopefully get some clear answers.

[LindaVillanova]

Thanks for sharing - I like to know as much as I can. Have been on OCA for 3 weeks so far, 1x/day - initial results show numbers coming down, which is positive.

I am monitored very closely by my Hep doc, 2 other groups (drug co and insurance co) with a hotline to call if I have any issues. Lots of support. I am scheduled for an ultrasound in a few weeks and blood work every 2 weeks for quite a while.

I will forward this to the support team for their input - but as others have said, take it with a grain of salt. I trust my Dr and others involved as they have proceeded very cautiously along this path.

Always open to more knowledge!

Thanks

Linda

[Sachin1234 in reply to LindaVillanova]

You will be all right Linda!!

🙏🙏🙏

[LindaVillanova in reply to Sachin1234]

I am not worried!!! But thanks for the support!

Happy to have an option since Urso isnt cutting it!

[gwillistexas in reply to LindaVillanova]

Myself, since I can't take Urso. That is what scared me do much👍

[LindaVillanova in reply to gwillistexas]

I can understand that - but have now been reassured by my support people the dosing error occurred only in very advanced stage people, not an issue for others

[Pippilotta]

Thank you for sharing. I think it is very important to stay informed!