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Ocaliva Drug Label Warnings vis-à-vis FDA Ocaliva Safety Signal Investigation

October 19, 2020 By Law Offices of Thomas J. Lamb, P.A.

In our last article, we reported on the current FDA investigation of an Ocaliva safety signal which, although it began in May 2020, only became public knowledge in October. The best we can tell, it is a possible Ocaliva liver toxicity issue that is the subject of this Ocaliva FDA investigation. Now we have some additional information about some … [Read more...]

Filed Under: Unsafe Drugs Tagged With: liver damage, liver failure, liver injury, Ocaliva

Current Ocaliva Liver Safety FDA Evaluation Started Back in May 2020

October 15, 2020 By Law Offices of Thomas J. Lamb, P.A.

In October 2020 we first learned about a "new" drug safety issue for Ocaliva -- although it apparently has been on the FDA's radar since at least May 2020. It seems a possible Ocaliva liver-related side effects risk has attracted scrutiny, and there is an Ocaliva liver safety FDA evaluation underway. It was this October 9, 2020, Endpoints News … [Read more...]

Filed Under: Unsafe Drugs Tagged With: drug-induced liver injury, liver damage, liver failure, liver injury, Ocaliva

Ocaliva Label Change Includes A Black-Box Warning About Liver Failure

February 7, 2018 By Law Offices of Thomas J. Lamb, P.A.

On February 1, 2018 the FDA issued this Safety Alert, “Ocaliva (obeticholic acid): Drug Safety Communication – Boxed Warning Added To Highlight Correct Dosing”, about an Ocaliva label change, from which we get this information: ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead … [Read more...]

Filed Under: Unsafe Drugs Tagged With: drug-induced liver injury, hepatic failure, liver failure, Ocaliva

Ocaliva Patients Died From Liver Injury Says September 2017 FDA Report

October 5, 2017 By Law Offices of Thomas J. Lamb, P.A.

A liver side effects issue for Ocaliva was presented in this document, “FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic chronic liver disease”, issued on September 21, 2017. From the Safety Announcement part of that document: The Food and Drug Administration (FDA) is warning … [Read more...]

Filed Under: Unsafe Drugs Tagged With: liver damage, liver failure, liver injury, Ocaliva

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