Statement from the Medical Advisory Committee of PBC Foundation
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Statement from the Medical Advisory Committee of PBC Foundation

Obeticholic acid (OCA) has recently been licenced in the UK and many other countries around the world for the treatment of people with PBC and is used in those who have not fully responded to or who are intolerant of Ursodeoxycholic acid. Clinical trials have shown that OCA is usually well tolerated and improves outcomes of people with PBC.

Recently, the manufacturers of OCA have written to health care practitioners in the US to inform them of a small number of cases in the US where there has been deterioration in liver function and even death following the prescription of OCA. These cases are being investigated and a causal relationship between the taking of OCA and the liver decompensation is being investigated.

A common factor was that the prescribed dose of OCA was greater than that recommended by the regulatory authorities and in the package insert. For those who have moderate or severe hepatic impairment (Child’s group B and C) should take OCA 5mg weekly: the frequency may be increased cautiously in some cases.

People with PBC should be reassured that prescription of OCA in the NHS in England is done only after assessment by a designated multi-disciplinary team (MDT) which includes experienced hepatologists and pharmacists; this will ensure that OCA is prescribed according to current guidelines. Other UK nations have developed similar approaches that will ensure that prescription is done in line with current guidance.

For anyone taking any medication or treatment:

1.       Be aware that all medications are associated with risk as well as benefit

2.       Carefully read the information provided

3.       Report any possible side-effects to your doctor/health care provider

4.       If you have any concerns about treatments, discuss them with your doctor/health care provider

Further information

Details about OCA is provided on

https://www.nice.org.uk/guidance/ta443/informationforpublic

https://ocaliva.com/

The letter from Intercept can be seen on

https://ocalivahcp.com/_assets/_pdfs/Ocaliva-Dear-HCP-Letter-9.8.17.pdf

 

20th September 2017