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...]
Guidelines for Diagnosing and Managing Patients with Drug-induced Liver Injury
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...]
Gilenya Label Change with New Liver Injury Risk Warnings in Canada
In the final two months of 2020, we saw a Gilenya label change adding new liver risk warnings announced by drug regulators in Europe, first, and the United Kingdom (UK), later. Next, in January 2021, Health Canada posted a Gilenya drug safety alert about patients developing Gilenya-associated liver injury, including acute liver failure … [Read more...]
Gilenya Linked To Acute Liver Failure, Drug-induced Liver Injury
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...]
Ocaliva Drug Label Warnings vis-à-vis FDA Ocaliva Safety Signal Investigation
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...]
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...]
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...]
Uterine Fibroid Drug Esmya Investigated Due to Severe Liver Injuries
About Esmya Esmya (ulipristal acetate) is indicated for the treatment of severe symptoms caused by uterine fibroids -- or noncancerous growths in the uterus -- in women of reproductive age. While Esmya is currently available in Europe, it is still pending FDA approval in the U.S. The active ingredient, ulipristal acetate is the same as that … [Read more...]
Ocaliva Patients Died From Liver Injury Says September 2017 FDA Report
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...]