Actemra and Liver Failure

Health Canada recently released a warning involving rheumatoid arthritis (RA) drug Actemra (tocilizumab), alerting patients and doctors to a potential link with acute liver failure.

Actemra was previously linked with an increased risk of heart attacks and strokes, but this is the first warning related to liver problems. The Canadian drug regulatory agency stated in their safety communication that “serious cases of drug-induced liver injuries have been reported in patients treated with Actemra, including cases of acute liver failure requiring a transplant.”

Actemra has been approved in Canada, as in the U.S., for the treatment of RA in adult patients with moderately to severely active RA. Considering this new information, Health Canada is working with manufacturers Roche and subsidiary Genentech to include this new safety information in the Canadian Product Monograph. It’s unclear at the time of this writing whether the agency may also require new warnings on the product label.

Health Canada Warns of Actemra Liver Damage

Health Canada—which is the country’s health regulatory agency, similar to the United States’ FDA—sent a letter to doctors advising them of the concern for liver injury. In that letter, they suggested that doctors not recommend Actemra to patients with active liver impairment or liver disease, and urged them to check patients’ liver function before prescribing the drug and then periodically during use to monitor for liver damage.

They also suggested doctors advise their patients to watch out for symptoms of liver problems, including loss of appetite, nausea and vomiting, fatigue, itching, dark urine, yellowing of the skin and eyes, abdominal swelling, and pain in the upper-right abdomen. Anyone experiencing these symptoms should check with a doctor immediately.

Data Shows Eight Cases of Actemra Liver Damage, Including Liver Failure

At Health Canada’s request, Actemra manufacturers performed a cumulative, comprehensive assessment of potential liver injury and liver failure with Actemra across all available clinical and post-marketing data sources, including the U.S. FDA’s Adverse Event Reporting System (FAERS).

Eight cases of Actemra-related moderate to severe liver injury were identified. They all occurred between 2 weeks and more than 5 years after the patients first started taking the drug. Two of the patients required a liver transplant.

So far, despite these reports, Genentech has not issued any warnings in the U.S. about a potential risk for liver damage. The prescribing information on the product suggests monitoring liver function but does not alert doctors or patients to the possibility of liver injury, liver failure, or the potential need for a liver transplant.

Patients who are taking the drug to treat RA who end up suffering from liver damage or liver failure may be eligible to file Actemra lawsuits to recover damages.

Actemra Linked to Heart Attacks and Strokes

Actemra was previously linked with a potential increased risk for heart attack and stroke. STAT News conducted an investigation into the drug, reviewing about 500,000 adverse event reports submitted to the FDA. The analysis of the data showed that 1,128 people died after using it.

There was reportedly no way to determine if Actemra caused those deaths, but in many of the reports, the doctors involved suggested a link between Actemra and the deaths. STAT added that there was clear evidence that the risks of heart attacks, strokes, and heart failure “were as high or higher for Actemra patients than for patients taking some competing drugs.”

So far, there is still no warning on the RA medication concerning heart attacks or strokes. For more information on Actemra and the STAT News investigation, see our main Actemra lawsuit page.

Actemra Liver Failure Lawsuits

If you or a loved one took Actemra and suffered serious liver impairment, liver injury, or liver failure requiring a transplant, you may be eligible to file an Actemra lawsuit to recover damages. Our dangerous drug attorneys now investigating these cases and encourage you to call today at 888-480-1123.