The FDA first issued a warning regarding the risk of serious liver injury with Ocaliva in September 2017. In early 2018, the FDA required the addition of a boxed warning, the most prominent type of FDA warning, to Ocaliva’s prescribing information to highlight these severe risks.
Another official warning focusing on liver injury was released by the FDA in May 2021, reminding healthcare professionals to adhere strictly to the recommended dosing, especially in patients with more advanced disease.
According to the warnings and documented side effects of liver disease progression, once a person begins to suffer from liver failure, they may begin to experience other symptoms like a build-up of fluid in the brain, seizures, coma, bleeding disorders, fluid retention and liver cancer.
As a result of the mounting Ocaliva side effects reported throughout the postmarketing studies, the FDA decided against giving Ocaliva full approval, after a scientific advisory committee voted against it, according to a November 12 press release by Intercept.
According to the FDA, postmarketing data showed that patients taking Ocaliva face a significantly higher risk of needing a liver transplant or dying compared to those taking a placebo, according to the FDA.
Among 81 Ocaliva patients considered at lower initial risk, seven ultimately required a liver transplant, while only one of the 68 placebo patients did. Notably, that single placebo patient had switched to Ocaliva for two years before needing the transplant, suggesting Ocaliva’s role in the injury.
Overall, the data indicates patients taking Ocaliva face a 377% increased risk of needing a liver transplant or dying. A total of four patients taking Ocaliva have died, compared to one patient in the placebo group.
FDA Ocaliva Recommendations
The FDA indicates doctors should conduct frequent liver tests and monitor the results to identify liver disease early and worsening liver function in patients taking Ocaliva. However, researchers said it is unclear if monitoring is sufficient to prevent serious liver injury.
The agency also recommends doctors explain the signs and symptoms of liver injury to Ocaliva patients, including symptoms such as yellow eyes or skin, bloody or black stool, coughing up or vomiting blood, change in mental status like confusion, slurred speech, increased sleepiness, stomach pain, nausea, vomiting, diarrhea, fever, weakness, and frequent urination.
The FDA requests any side effects linked to taking Ocaliva, such as liver disease and liver failure, should be reported to the FDA’s MedWatch Adverse Event Reporting Program.