Home Page Potential Lawsuit FDA Issues Warning for Ocaliva
FDA Issues Warning for Ocaliva
Washington, DC: The US Food and Drug Administration (FDA) has issued a 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.
According to the FDA warning , some 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.
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.
The FDA notes in its warning letter that the following symptoms may be signs of liver injury:
New or worsening fatigue
Nausea and vomiting
Change in behavior or confusion
Vague symptoms such as anxiety or unease
Yellow eyes or skin
Legal HelpIf you or a loved one has suffered similar damages or injuries, please fill in our form and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Sep-21-17
READ MORE [ Defective Products Settlements and Legal News ]
READ MORE [ Drugs/Medical Settlements and Legal News ]
READ MORE [ Personal Injury Settlements and Legal News ]
ADD YOUR COMMENT ON THIS ISSUE