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...]
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...]
Lemtrada Safety Issues Lead To Use Restrictions In Europe
Drug safety regulators for the European Union recently recommended that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada. This November 5, 2019 Multiple Sclerosis News Today report, “EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals … [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...]
Lemtrada Side Effects Being Investigated By European Drug Regulatory Agency
The multiple sclerosis drug Lemtrada (alemtuzumab) is under scrutiny from the European Medicines Agency (EMA), according to the drug regulator’s April 12, 2019 press release, “Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing”. From this April 14, 2019 Medscape article, “PRAC Restricts Use of Alemtuzumab for MS … [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 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...]
Warnings About Significant Liver Injury Added To Tecfidera Drug Label
In January 2017 liver injury was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera (dimethyl fumarate), which was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS). We get background information and some commentary from this … [Read more...]
Safety of Hepatitis C Treatment Drugs Called Into Question
UPDATE: On February 14, 2017, the FDA released a Black Box warning for these drugs with the following text:Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.(2/16/17).Recently, the safety of the newer hepatitis C treatment drugs -- such as Solvadi and Harvoni -- is … [Read more...]