The FDA has issued a warning about a liver disease medication Ocaliva after 19 reported fatalities were linked to incorrect dosing.
Ocaliva (obeticholic acid) is prescribed to people with a chronic liver disease known as primary biliary cholangitis (PBC). The FDA believes the 19 patients received an overdose of the medication. In addition, 11 cases of serious liver injury related to Ocaliva use were reported to the FDA.
The drug’s label information recommends that a patient should not take more than 10 mg twice a week. However, it was reported that 7 patients with moderate to severe liver disease received 5 mg of Ocaliva daily. What’s even more alarming is that patients with milder liver disease were prescribed this medication, and may have experienced liver injury after receiving the correct dose of Ocaliva.
The agency urges patients to closely monitor the onset of possible side effects and contact their doctor if they begin to experience the following symptoms that may be associated with liver damage:
- New or worsening fatigue
- Diarrhea
- Weight loss
- Abdominal pain
- Decreased appetite
- Nausea and vomiting
- Change in behavior or confusion
- Vague symptoms such as anxiety or unease
- Abdominal swelling
- Yellow eyes or skin
- Bloody stools
