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...]
Current Ocaliva Liver Safety FDA Evaluation Started Back in May 2020
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...]
Actemra Liver Injury Risks Warnings Added To Drug Label In June 2019
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...]
Actemra Drug-Induced Liver Injuries Warning From Health Canada
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...]
Pradaxa Liver Injury: Label Changes Warning About This Increased Risk
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...]
Ocaliva Label Change Includes A Black-Box Warning About Liver Failure
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...]
Health Canada: OFEV Label Will Add Drug-Induced Liver Injury Warning
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...]
Limbrel Medical Food Product for Osteoarthritis Removed from the Market
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...]
Primus Pharmaceuticals Refuses To Recall Limbrel Despite FDA Request
On November 21, 2017 the FDA issued this Safety Alert for Human Medical Products: “Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory – Linked to Potentially Life-Threatening Health Problems”. More recently, there was a December 4, 2017 FDA statement which can be found on this Safety Alerts & Advisories page, “FDA Alerts Consumers … [Read more...]