Actemra Health Canada Liver Warnings
Canada’s health authority, Health Canada, which is similar to the U.S. Food and Drug Administration (FDA) has issued a “Dear Doctor” letter addressed to healthcare professionals warning of the possibility of liver injury in patients who use Actemra.
The May 21, 2019 safety alert indicates that a number of serious drug-induced liver injury cases have been reported in patients who use Actemra, some of which have resulted in acute liver failure and may have required liver transplant. The warning recommends that Actemra should not be used in patients with active liver disease or liver impairment. Practitioners should test liver function tests and enzymes before starting therapy and every 4 to 8 weeks in adults and 2 to 4 weeks in children.
Health Canada advised healthcare professionals to: not start patients on medication if liver enzymes are 3 times higher than normal range; discontinue medication if liver enzymes exceed 5 times normal; and use Actemra only with caution in patients whose liver enzymes are 1.5 times normal.
Patients should be advised to contact their healthcare provider if signs of liver injury occur such as:
- Nausea and vomiting
- Loss of appetite
- Dark urine
- Yellowing of skin or eyes
- Abdominal swelling
- Pain in upper abdomen
The alert was issued after Health Canada requested information from Genentech about their RA drug, Actemra. Information about the risk was compiled from Genentech records which included FDA reports of liver injury and hepatic failure, but the company has not changed prescribing information to include the warning.
Actemra Liver Failure Lawsuit
Actemra (tocilizumab) is used to treat rheumatoid arthritis and other autoimmune disorders. Despite the reports of liver failure associated with Actemra and warnings from Health Canada, the prescribing information for Actemra in the U.S. fails to include a warning for liver failure and those injured as a result may be filing Actemra lawsuits for liver injury, liver failure and other serious side effects.
|Classification||Monoclonal antibody immune modulator|
|Dosage form(s)||80mg/4ml, 200mg/10ml, 400mg/20ml solution for injection to be formulated as infusion|
162mg/0.9ml prefilled syringe for subcutaneous injection
|Normal dosage||4mg/kg patient weight every 4 weeks by IV infusion, may increase to 8mg/kg every 4 weeks|
patients under 100kg (220 pounds) – 162mg subcutaneous (SC) injection every 2 weeks
patients over 100kg – 162mg SC every week
Lack of Actemra Safety Warnings in U.S.
Since the drug was first approved in the United States in 2010, Actemra’s prescribing information has included instructions to monitor liver function but has never included a warning about the possibility of acute liver injury or failure.
Genentech may be facing a number of Actemra lawsuits due to the increased risk of liver failure and other serious liver injuries caused by the medication.
People or loved ones of those who have suffered liver damage, experienced liver failure, required a liver transplant or who died due to Actemra use should seek legal advice. If you or a loved one experienced liver failure after taking Actemra, call us today for a free case evaluation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.