What are the side effects of obeticholic acid?

Obeticholic acid is a drug used to treat primary cholangitis (PBC). Although it has shown certain efficacy in clinical application, it is also accompanied by a variety of side effects. In clinical studies, the most common adverse reactions included pruritus, fatigue, abdominal pain, and discomfort. Itching is one of the main symptoms reported by patients, and many patients experience this discomfort within the first month after starting treatment. Although symptoms usually decrease over time, in some cases, this itching may cause patients to discontinue treatment. In addition to itching, patients may experience persistent fatigue, abdominal discomfort, and pain, which can affect their quality of daily life.

In addition, some patients may experience other uncomfortable symptoms such as rash, joint pain, sore throat, dizziness, constipation, and peripheral edema after taking obeticholic acid. Heart palpitations and fever are also side effects reported by some patients, while the risk of thyroid dysfunction is of particular concern as this may have long-term effects on the patient's overall health. The occurrence of eczema has also been documented, further demonstrating the skin-related problems this drug can cause.

More seriously, during post-marketing surveillance,FDA reported a number of serious adverse events related to the use of obeticholic acid, including liver failure, new cirrhosis, increased direct bilirubin and total bilirubin levels, and new or worsening jaundice. These adverse reactions prompt health care providers to be cautious when prescribing to patients, especially if there is a potential impact on liver health.

Accordingly, the use of obeticholic acid is expressly contraindicated in certain patient groups, including patients with decompensated cirrhosis (e.g.Child-Pugh class B or C), patients with previous decompensation events, and patients with compensated cirrhosis with evidence of portal hypertension, such as ascites, gastroesophageal varices, and sustained thrombocytopenia. In addition, patients with complete biliary obstruction should not use this drug to avoid possible harm.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cdfbe0cd-eb15-45a1-ac17-531bcda21aec