Actemra Side Effects Increase Risk Of Blood Loss After Knee Replacement Surgery: Study

A new study warns that side effects of Actemra may include an increased risk of blood loss for patients undergoing knee replacement surgery. 

Japanese researchers warn that the new-generation arthritis drug Actemra appears to result in lower preoperative fibrinogen levels for patients, causing them to lose more blood than others during total knee arthroplasty (TKA). The findings were published last week in the medical journal Modern Rheumatology.

Actemra (tocilizumab) was introduced by Roche in 2010, as a second-line medication primarily prescribed to treat severe cases of rheumatoid arthritis that may not have responded to other drugs. However, in May 2017, the drug maker obtained expanded approval of Actemra injections for giant cell arthritis.

Researchers from Tokyo Women’s Medical University looked at 115 rheumatoid arthritis (RA) patients who underwent knee replacement surgery. The patients were preoperatively tested for fibrinogen levels and blood loss was measured following surgery.

Fibrinogens are glycoproteins in the blood that helps stop excessive bleeding.

According to the findings, patients treated with Actemra had significantly lower preoperative fibrinogen levels than those not treated with Actemra. In addition, the researchers found that patients treated with Actemra suffered a greater amount of blood loss following knee replacement surgery, with a mean total volume of blood loss of 797.1 mL, compared to 511.4 mL of blood loss suffered by patients not on Actemra.

Actemra Health Risks

Actemra has become a blockbuster treatment for Roche, generating over $1.6 billion in annual sales, since it was widely thought by many doctors that it does not carry some of the same health risks associated with competing rheumatoid arthritis drugs, such as Humira, Remicade and Enbrel. However, concerns have emerged in recent months about potential Actemra health risks, after an independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis.

In July, the findings of phase III clinical trials for the use of Actemra for giant cell arthritis showed that it had benefits for patients, but also revealed that 15% suffered adverse side effects.

Adding to the Actemra problems for Roche, another study published in July in the medical journal Rheumatology found that individuals with a specific type of rheumatoid arthritis (RA), known as anti-citrullinated protein antibody (ACPA) negative, face a higher risk of infections than those with ACPA-positive rheumatoid arthritis.

Unlike other competing rheumatoid arthritis drugs, Actemra warnings do not include information about certain health risks linked to competing treatments, such as Humira, Remicade and Enbrel. Therefore, many doctors and consumers are under the impression that Actemra is safer. However, recent reports suggest that users may face the same, or higher risks.

A recent independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis. In addition, the drug has been linked to at least 1,128 deaths since 2010. As a result, some are calling for Actemra warnings to be added, which may cut into sales.

A number of product liability lawyers are now reviewing potential Actemra lawsuits, indicating that evidence suggests that Roche knew or should have known that the drug carried similar risks to other rheumatoid arthritis drugs, but withheld information from the label to create a false impression that their drug was safer.