Serious Cases Of Hepatic Injury Some Of Which Have Resulted In Liver Transplant Or Death Reported As Side Effects
On May 21, 2019 we posted this article, "Risk Of Actemra Associated Liver Injury Being Assessed By Health Canada, With Drug Label Change Likely To Follow", which ended with this sentence: "We will watch to see whether the FDA issues a similar drug safety warning about Actemra-related liver injury and mandates a drug label change here in the US."
Now, about three weeks later, we have our answer as regards an Actemra label change which adds warnings about the increased risk of liver injury.
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):
Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous ACTEMRA. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation with [Actemra (tocilizumab)]. While most cases presented with marked elevations of transaminases (> 5 times ULN), some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases….
Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient is found to have abnormal liver tests (e.g., ALT greater than three times the upper limit of the reference range, serum total bilirubin greater than two times the upper limit of the reference range), ACTEMRA treatment should be interrupted and investigation done to establish the probable cause. ACTEMRA should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.
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Here are a couple of other earlier Actemra articles we posted on Drug Injury Watch:
- Actemra Side Effects: Pulmonary Hypertension, Interstitial Lung Disease, Pulmonary Alveolar Proteinosis (August 2018)
- Despite The High Number Of Actemra - Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label (June 2017)
We are currently investigating cases of these Actemra side effects as possible drug injury lawsuits against Genentech, Inc., the responsible drug company.
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