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Ocaliva Lawsuit

Abbott Law Group, P.A. > Class Actions > Ocaliva Lawsuit

The Abbott Law Group attorneys are now reviewing claims for people injured by Ocaliva (obeticolic acid) from Intercept Pharmaceuticals Inc., a liver disease drug that may be linked to serious liver injury and death. If you currently take or have taken the drug Ocaliva, you may be eligible to file Ocaliva class action lawsuit.

On September 21, 2017, the Food and Drug Administration (FDA) issued a warning that the liver disease medicine Ocaliva (obeticolic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed. This in turn causes bile (a fluid that helps in digestion) to build up in the liver, over time damaging it, and ultimately losing its ability to function.

FDA Drug Safety Announcement

The FDA reports that these patients are receiving excessive dosing, particularly a higher frequency of dosing (more often) than is recommended in the drug label for them. The FDA further reports that Ocaliva also may be associated with liver injury in some patients with mild disease who are receiving the correct dose. The FDA states that it is working with the drug manufacturer (Intercept Pharmaceuticals) to address these safety concerns.

Drug Safety Communication

[09-21-2017] The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. We are working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.

Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed. This causes bile, a fluid that helps in digestion, to build up in the liver. This build-up damages the liver over time, eventually causing it to lose its ability to function. Ocaliva has been shown to improve a certain blood test that measures liver problems.

Nineteen cases of death were identified, of which eight provided information about the patient’s cause of death. The cause of death was reported to be worsening of PBC disease in seven cases, with cardiovascular disease cited in the other case. Seven of these eight cases described patients with moderate to severe decreased liver function who received Ocaliva 5 mg daily, instead of a dose no greater than 10 mg twice weekly as recommended in the label prescribing information for patients with this extent of decreased liver function.

Resources

9/21/2017 Bloomberg – FDA Warns Doctors After 19 Deaths on Intercept Liver Drug

9/21/2017 U.S. Food & Drug Administration – FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease