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Ocaliva-related Liver Injury Warnings Will be Added to Ocaliva Drug Label

June 1, 2021 By Law Offices of Thomas J. Lamb, P.A.

We now know more about the Ocaliva-related liver injury “safety signal” that the FDA has been investigating over the past year, and as a result of that Ocaliva FDA safety evaluation there will be an Ocaliva label change with new warnings. On May 26, 2021, this FDA Drug Safety Communication about Ocaliva, “Due to risk of serious liver injury, FDA … [Read more...]

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

Guidelines for Diagnosing and Managing Patients with Drug-induced Liver Injury

May 10, 2021 By Law Offices of Thomas J. Lamb, P.A.

We continue to monitor the medical literature for developments relevant to the important drug safety issue of drug-induced liver injury (DILI). This medical journal article, “ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury”, appeared in The American Journal of Gastroenterology (AJC) May 2021 … [Read more...]

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

Gilenya Linked To Acute Liver Failure, Drug-induced Liver Injury

November 13, 2020 By Law Offices of Thomas J. Lamb, P.A.

As reported in this European Medicines Agency (EMA) periodic safety update report, “Gilenya (fingolimod): Updated recommendations to minimise the risk of drug-induced liver injury (DILI)”, published November 10, 2020, there have been cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya. A Direct Healthcare … [Read more...]

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

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

Actemra Liver Injury Risks Warnings Added To Drug Label In June 2019

June 18, 2019 By Law Offices of Thomas J. Lamb, P.A.

The FDA sent an email on June 13, 2019 about Drug Safety-related Labeling Changes (SrLC) which alerted us to a revised version of the Actemra Prescribing Information document used in the US. Upon review of this new section added to the “Warnings and Precautions” part of the June 2019 Actemra drug label (accessed 6/13/19): 5.3 … [Read more...]

Filed Under: Unsafe Drugs Tagged With: Actemra, drug-induced liver injury, liver injury, liver transplants

Actemra Drug-Induced Liver Injuries Warning From Health Canada

May 29, 2019 By Law Offices of Thomas J. Lamb, P.A.

Actemra drug-induced liver injuries, which can be serious, life-threatening, or even fatal. This is according the Canadian drug regulatory agency, Health Canada, which issued this Dear Healthcare Professional Letter, “Important Safety Information on ACTEMRA ® (tocilizumab) – Risk of Hepatotoxicity”, on May 21, 2019. From this Health Canada … [Read more...]

Filed Under: Uncategorized, Unsafe Drugs Tagged With: Actemra, drug-induced liver injury, liver damage, liver failure, liver transplants

Pradaxa Liver Injury: Label Changes Warning About This Increased Risk

July 27, 2018 By Law Offices of Thomas J. Lamb, P.A.

We are watching to see whether the FDA and/or European drug regulators require a Pradaxa liver injury label change adding a new warning about an increased risk of acute liver failure and drug-induced hepatitis — like what was done in Japan last year and is being done now in Canada. In May 2018 Health Canada announced that their Pradaxa drug … [Read more...]

Filed Under: Unsafe Drugs Tagged With: drug side effects, drug-induced liver injury, liver damage, liver failure, liver injury, Pradaxa

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

Health Canada: OFEV Label Will Add Drug-Induced Liver Injury Warning

January 16, 2018 By Law Offices of Thomas J. Lamb, P.A.

On January 11, 2018 Health Canada issued a Dear Healthcare Professional Letter communication titled “OFEV (nintedanib) – Risk of Drug-Induced Liver Injury and the Need for Regular Monitoring of Liver Function”. From the Background Information section of that new Health Canada document we get this overview of the safety issue: OFEV (nintedanib) … [Read more...]

Filed Under: Unsafe Drugs Tagged With: drug injury, drug side effects, drug-induced liver injury, OFEV

Limbrel Medical Food Product for Osteoarthritis Removed from the Market

January 12, 2018 By Law Offices of Thomas J. Lamb, P.A.

Background Limbrel (flavocoxid) is an anti-inflammatory agent comprised mostly of flavonoids such as baicalin and catechin that is prescribed to manage the metabolic processes associated with osteoarthritis. This supplement has traditionally been classified and marketed as a "medical food," which is defined by the Orphan Drug Act as: "a food … [Read more...]

Filed Under: Unsafe Drugs Tagged With: DILI, drug-induced liver injury, FDA, flavocoxid, hypersensitivity pneumonitis, limbrel, medical food, Pancreatitis, recall, side effects

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